Associate Director, External Site Quality Lead, External Quality Assurance Drug Product (Pittston)

Compensation

: $105,360.00 - $158,170.00 /year *

Employment Type

: Full-Time

Industry

: Executive Management



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Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The position corresponds to a team leader responsible for implementing the our Company's Quality Assurance policy and discharging Quality responsibilities for the oversight of contract manufacturing organizations that supply drug products to our Company.

The responsibilities of this position may include the quality oversight of contract manufacture, testing, packaging, storage, and/or distribution of pharmaceutical products and drug delivery systems with particular focus on the deviation management quality system, including coordination of significant investigations and regulatory agency notifications.

These activities include assuring that products are manufactured/packaged from approved processes in conformance to all applicable regulatory requirements and Company policies.

The incumbent will exercise a leadership role in monitoring and maintaining contracted third-party compliance with the FDC Act, Current Good Manufacturing Practices Regulations (domestic and foreign), and other pertinent legal requirements.

The incumbent may also ensure the quality performance of the Contract Manufacturer/Packager through direct oversight, support and technical advice, counseling to the third-party site senior leadership and providing on-site supervision as appropriate. This may include participation in activities such as third-party selection, GMP Due Diligence, and establishing of Quality Agreements.

The incumbent also provides support to build effective quality systems and drive continuous improvement activities at the Contract Manufacturer/Packager; and maintains compliance with the Quality Agreements between the parties.

The incumbent is expected to drive collaboration within internal and external cross-functional groups to achieve objectives and communicate company expectations as necessary to improve relationship performance against agreed upon metrics and business goals.

Qualifications

Education:
  • Bachelor's degree in science, engineering, or related areas of study.
Required:
  • A minimum of five (5) years of experience working in the Pharmaceutical industry, with strong knowledge of and broad experience in Quality Assurance and Quality Control activities, particularly applied to deviation management, as well as significant investigation and Fact Finding coordination.
  • Experience in Quality Agreement development and cross-functional teamwork is required.
  • Familiarity with Field Alert Reporting is also required.
Preferred:
  • Strong demonstrated communication skills.
  • Prior experience managing 3rd Party relationships preferred.
  • Demonstrated personal networking and relationship building skills.
  • Conversant on domestic and foreign regulations and compendia governing manufacturing operations.
  • Contractual and financial awareness is preferred.
  • Experience in Lean project implementation also preferred.
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that?s committed to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are ?

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as ?Merck? in the United States, Canada & Puerto Rico. We are known as ?MSD? in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world?s biggest investors in Research & Development.

What we look for ?

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

If you need an accommodation for the application process please email us at ...@merck.com

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster
EEOC GINA Supplement?
OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran ? proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

25%

Flexible Work Arrangements:

Remote Work

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The position corresponds to a team leader responsible for implementing the our Company's Quality Assurance policy and discharging Quality responsibilities for the oversight of contract manufacturing organizations that supply drug products to our Company.

The responsibilities of this position may include the quality oversight of contract manufacture, testing, packaging, storage, and/or distribution of pharmaceutical products and drug delivery systems with particular focus on the deviation management quality system, including coordination of significant investigations and regulatory agency notifications.

These activities include assuring that products are manufactured/packaged from approved processes in conformance to all applicable regulatory requirements and Company policies.

The incumbent will exercise a leadership role in monitoring and maintaining contracted third-party compliance with the FDC Act, Current Good Manufacturing Practices Regulations (domestic and foreign), and other pertinent legal requirements.

The incumbent may also ensure the quality performance of the Contract Manufacturer/Packager through direct oversight, support and technical advice, counseling to the third-party site senior leadership and providing on-site supervision as appropriate. This may include participation in activities such as third-party selection, GMP Due Diligence, and establishing of Quality Agreements.

The incumbent also provides support to build effective quality systems and drive continuous improvement activities at the Contract Manufacturer/Packager; and maintains compliance with the Quality Agreements between the parties.

The incumbent is expected to drive collaboration within internal and external cross-functional groups to achieve objectives and communicate company expectations as necessary to improve relationship performance against agreed upon metrics and business goals.

Qualifications

Education:
  • Bachelor's degree in science, engineering, or related areas of study.
Required:
  • A minimum of five (5) years of experience working in the Pharmaceutical industry, with strong knowledge of and broad experience in Quality Assurance and Quality Control activities, particularly applied to deviation management, as well as significant investigation and Fact Finding coordination.
  • Experience in Quality Agreement development and cross-functional teamwork is required.
  • Familiarity with Field Alert Reporting is also required.
Preferred:
  • Strong demonstrated communication skills.
  • Prior experience managing 3rd Party relationships preferred.
  • Demonstrated personal networking and relationship building skills.
  • Conversant on domestic and foreign regulations and compendia governing manufacturing operations.
  • Contractual and financial awareness is preferred.
  • Experience in Lean project implementation also preferred.
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that?s committed to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are ?

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as ?Merck? in the United States, Canada & Puerto Rico. We are known as ?MSD? in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world?s biggest investors in Research & Development.

What we look for ?

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

If you need an accommodation for the application process please email us at ...@merck.com

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster
EEOC GINA Supplement?
OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran ? proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

25%

Flexible Work Arrangements:

Remote Work

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The position corresponds to a team leader responsible for implementing the our Company's Quality Assurance policy and discharging Quality responsibilities for the oversight of contract manufacturing organizations that supply drug products to our Company.

The responsibilities of this position may include the quality oversight of contract manufacture, testing, packaging, storage, and/or distribution of pharmaceutical products and drug delivery systems with particular focus on the deviation management quality system, including coordination of significant investigations and regulatory agency notifications.

These activities include assuring that products are manufactured/packaged from approved processes in conformance to all applicable regulatory requirements and Company policies.

The incumbent will exercise a leadership role in monitoring and maintaining contracted third-party compliance with the FDC Act, Current Good Manufacturing Practices Regulations (domestic and foreign), and other pertinent legal requirements.

The incumbent may also ensure the quality performance of the Contract Manufacturer/Packager through direct oversight, support and technical advice, counseling to the third-party site senior leadership and providing on-site supervision as appropriate. This may include participation in activities such as third-party selection, GMP Due Diligence, and establishing of Quality Agreements.

The incumbent also provides support to build effective quality systems and drive continuous improvement activities at the Contract Manufacturer/Packager; and maintains compliance with the Quality Agreements between the parties.

The incumbent is expected to drive collaboration within internal and external cross-functional groups to achieve objectives and communicate company expectations as necessary to improve relationship performance against agreed upon metrics and business goals.

Qualifications

Education:
  • Bachelor's degree in science, engineering, or related areas of study.
Required:
  • A minimum of five (5) years of experience working in the Pharmaceutical industry, with strong knowledge of and broad experience in Quality Assurance and Quality Control activities, particularly applied to deviation management, as well as significant investigation and Fact Finding coordination.
  • Experience in Quality Agreement development and cross-functional teamwork is required.
  • Familiarity with Field Alert Reporting is also required.
Preferred:
  • Strong demonstrated communication skills.
  • Prior experience managing 3rd Party relationships preferred.
  • Demonstrated personal networking and relationship building skills.
  • Conversant on domestic and foreign regulations and compendia governing manufacturing operations.
  • Contractual and financial awareness is preferred.
  • Experience in Lean project implementation also preferred.
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that?s committed to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are ?

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as ?Merck? in the United States, Canada & Puerto Rico. We are known as ?MSD? in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world?s biggest investors in Research & Development.

What we look for ?

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

If you need an accommodation for the application process please email us at ...@merck.com

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster
EEOC GINA Supplement?
OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran ? proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

25%

Flexible Work Arrangements:

Remote Work

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

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Associate Director, External Site Quality Lead, External Quality Assurance Drug Product

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  • Job
Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The position corresponds to a team leader responsible for implementing the our Company's Quality Assurance policy and discharging Quality responsibilities for the oversight of contract manufacturing organizations that supply drug products to our Company.

The responsibilities of this position may include the quality oversight of contract manufacture, testing, packaging, storage, and/or distribution of pharmaceutical products and drug delivery systems with particular focus on the deviation management quality system, including coordination of significant investigations and regulatory agency notifications.

These activities include assuring that products are manufactured/packaged from approved processes in conformance to all applicable regulatory requirements and Company policies.

The incumbent will exercise a leadership role in monitoring and maintaining contracted third-party compliance with the FDC Act, Current Good Manufacturing Practices Regulations (domestic and foreign), and other pertinent legal requirements.

The incumbent may also ensure the quality performance of the Contract Manufacturer/Packager through direct oversight, support and technical advice, counseling to the third-party site senior leadership and providing on-site supervision as appropriate. This may include participation in activities such as third-party selection, GMP Due Diligence, and establishing of Quality Agreements.

The incumbent also provides support to build effective quality systems and drive continuous improvement activities at the Contract Manufacturer/Packager; and maintains compliance with the Quality Agreements between the parties.

The incumbent is expected to drive collaboration within internal and external cross-functional groups to achieve objectives and communicate company expectations as necessary to improve relationship performance against agreed upon metrics and business goals.

Qualifications

Education:
  • Bachelor's degree in science, engineering, or related areas of study.
Required:
  • A minimum of five (5) years of experience working in the Pharmaceutical industry, with strong knowledge of and broad experience in Quality Assurance and Quality Control activities, particularly applied to deviation management, as well as significant investigation and Fact Finding coordination.
  • Experience in Quality Agreement development and cross-functional teamwork is required.
  • Familiarity with Field Alert Reporting is also required.
Preferred:
  • Strong demonstrated communication skills.
  • Prior experience managing 3rd Party relationships preferred.
  • Demonstrated personal networking and relationship building skills.
  • Conversant on domestic and foreign regulations and compendia governing manufacturing operations.
  • Contractual and financial awareness is preferred.
  • Experience in Lean project implementation also preferred.
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that?s committed to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are ?

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as ?Merck? in the United States, Canada & Puerto Rico. We are known as ?MSD? in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world?s biggest investors in Research & Development.

What we look for ?

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

If you need an accommodation for the application process please email us at ...@merck.com

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster
EEOC GINA Supplement?
OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran ? proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

25%

Flexible Work Arrangements:

Remote Work

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

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Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The position corresponds to a team leader responsible for implementing the our Company's Quality Assurance policy and discharging Quality responsibilities for the oversight of contract manufacturing organizations that supply drug products to our Company.

The responsibilities of this position may include the quality oversight of contract manufacture, testing, packaging, storage, and/or distribution of pharmaceutical pro
Associated topics: administrative support, assist, assistant, associate, beverage, facilities, front desk, food, operations director, records management * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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