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Sr Manager, Quality Assurance - Pharma (Remote)

Sr Manager, Quality Assurance - Pharma (Remote)

 

As a leader in the science of nutrition, Nestlé Health Science believes in empowering healthier lives for patients and consumers through a rich product portfolio featuring top brands such as Garden of Life®, Nature’s Bounty®, Vital Proteins®, Nuun®, Persona Nutrition®, BOOST®, Carnation Breakfast Essentials®, Peptamen®, Compleat Organic Blends®, and more, as well as through Aimmune Therapeutics, a biopharmaceutical company developing therapies to prevent, manage and treat food, GI and metabolic-related diseases.

 

Our team members are challenged to make a genuine impact and play an integral role in driving the business forward. We embrace a dynamic culture that always puts the consumer first, and where ownership, accountability and agility are celebrated at every level. To help our people thrive, we offer expansive career growth potential, the opportunity to work alongside and learn from talented colleagues with diverse backgrounds and skill sets, and a range of best-in-class benefits.

 

We have more than 11,000 employees around the world, and products available in over 140 countries.

 

This position is not eligible for Visa Sponsorship.

 

 

Requisition ID

175880 

175880 

Position Summary

Summary:

Provide Quality oversight of cGMP operations performed for Aimmune at Contract Manufacturing Organizations (CMOs) and/or Contract Testing Labs (CTLs) per the global regulatory requirements.  Additional responsibilities may include conducting internal/external audits and participate in inspection readiness activities.  This position provides Quality recommendations and guidance to project teams and manages other compliance duties as assigned.


Specific Responsibilities:

  •  Work directly with operating entities (internal and CMOs/CTLs) to ensure that clinical drug substance and drug products meet all required quality standards and specifications or are appropriately investigated.
  •  Provide effective QA support for the manufacturing and disposition of clinical drug product lots.
  • Review and approve internal and CMO/CTL deviations, OOS, lab investigations, change controls.
  • Review and approve the CMO/CTL Specifications, Test Methods, Analytical Method Validation Protocols/Reports and Stability Protocols/Reports as assigned.
  • Work with CMOs/CTLs to ensure that policies at CMOs/CTLs adhere to cGMPs and regulatory requirements of FDA, EMA and other regulatory agencies, as required.
  • Demonstrate proven strategies for coping with early-stage product development including the ability to be flexible with requirements based on phase appropriateness. 
  • Ensure that Quality policies and practices at CMOs/CTLs adhere to approved quality agreements, monitor, and provide corrective action recommendations to compliance issues and/or observations as they arise.  Manage and coordinate process monitoring and continuous improvement initiatives as per cGMP requirements, as required
  • Support and ensure CMOs/CTLs achieve the appropriate levels of compliance and develop plans to ensure on-going performance is maintained.
  •  Resolve of quality issues in a timely manner.  Coordinate communication with contract manufacturers and internal cross functional teams for quality issues.
  • Establish or revise assigned internal SOPs/Guidelines applicable to internal functions as well as outsourced functions to ensure compliance to cGMP.
  • Ensure compliance with the Quality Systems such as change control, quality investigations, and CAPA resolutions.  Management of assigned QA operation tasks in accordance to SOPs.
  • Perform QA audits/inspections (internal and external) as assigned.
  • Represent QA in multi-departmental meetings & project teams.
  • Manage, oversee, develop, if applicable, and/or contract support personnel..

Qualifications

  • Bachelor of Arts/Sciences (BA/BS) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
  • 5+ years’ experience in a cGMP regulated environment, with exhibited knowledge or proficiency in Quality Assurance.
  • Organizational and management skills to communicate to multi-discipline project groups. Ability to speak, present data, and defend approaches in front of audiences and inspectors.
  • Proficiency with Office software applications, including MS Word, MS Excel, MS Project, MS Power Point.
  • Proficiency with technical summary report reviews required, with exceptional organizational attention to detail.
  • Knowledge of industry standards, guidance documents, and global regulatory requirements from Phase I to Phase III is required.

.
 

 

It is our business imperative to remain a very inclusive workplace.

 

To our veterans and separated service members, you're at the forefront of our minds as we recruit top talent to join Nestlé. The skills you've gained while serving our country, such as flexibility, agility, and leadership, are much like the skills that will make you successful in this role.  In addition, with our commitment to an inclusive work environment, we recognize the exceptional engagement and innovation displayed by individuals with disabilities.  Nestlé seeks such skilled and qualified individuals to share our mission where you’ll join a cohort of others who have chosen to call Nestlé home.

 

The Nestlé Companies are an equal employment opportunity and affirmative action employer seeking diversity in qualified applicants for employment.  All applicants will receive consideration for employment without regard to race, ethnicity, color, gender, gender identity, age, religion, national origin, ancestry, disability, perceived disability, medical condition, genetic information, veteran status, sexual orientation, or any other protected status, as defined by applicable law. Prior to the next step in the recruiting process, we welcome you to inform us confidentially if you may require any special accommodations in order to participate fully in our recruitment experience. Contact us at accommodations@nestle.com or please dial 711 and provide this number to the operator: 1-800-321-6467.

 

This position is not eligible for Visa Sponsorship.

 

 

 

As a leader in the science of nutrition, Nestlé Health Science believes in empowering healthier lives for patients and consumers through a rich product portfolio featuring top brands such as Garden of Life®, Nature’s Bounty®, Vital Proteins®, Nuun®, Persona Nutrition®, BOOST®, Carnation Breakfast Essentials®, Peptamen®, Compleat Organic Blends®, and more, as well as through Aimmune Therapeutics, a biopharmaceutical company developing therapies to prevent, manage and treat food, GI and metabolic-related diseases.

 

Our team members are challenged to make a genuine impact and play an integral role in driving the business forward. We embrace a dynamic culture that always puts the consumer first, and where ownership, accountability and agility are celebrated at every level. To help our people thrive, we offer expansive career growth potential, the opportunity to work alongside and learn from talented colleagues with diverse backgrounds and skill sets, and a range of best-in-class benefits.

 

We have more than 11,000 employees around the world, and products available in over 140 countries.

 

This position is not eligible for Visa Sponsorship.

 

 

Requisition ID

175880 

175880 

Position Summary

Summary:

Provide Quality oversight of cGMP operations performed for Aimmune at Contract Manufacturing Organizations (CMOs) and/or Contract Testing Labs (CTLs) per the global regulatory requirements.  Additional responsibilities may include conducting internal/external audits and participate in inspection readiness activities.  This position provides Quality recommendations and guidance to project teams and manages other compliance duties as assigned.


Specific Responsibilities:

  •  Work directly with operating entities (internal and CMOs/CTLs) to ensure that clinical drug substance and drug products meet all required quality standards and specifications or are appropriately investigated.
  •  Provide effective QA support for the manufacturing and disposition of clinical drug product lots.
  • Review and approve internal and CMO/CTL deviations, OOS, lab investigations, change controls.
  • Review and approve the CMO/CTL Specifications, Test Methods, Analytical Method Validation Protocols/Reports and Stability Protocols/Reports as assigned.
  • Work with CMOs/CTLs to ensure that policies at CMOs/CTLs adhere to cGMPs and regulatory requirements of FDA, EMA and other regulatory agencies, as required.
  • Demonstrate proven strategies for coping with early-stage product development including the ability to be flexible with requirements based on phase appropriateness. 
  • Ensure that Quality policies and practices at CMOs/CTLs adhere to approved quality agreements, monitor, and provide corrective action recommendations to compliance issues and/or observations as they arise.  Manage and coordinate process monitoring and continuous improvement initiatives as per cGMP requirements, as required
  • Support and ensure CMOs/CTLs achieve the appropriate levels of compliance and develop plans to ensure on-going performance is maintained.
  •  Resolve of quality issues in a timely manner.  Coordinate communication with contract manufacturers and internal cross functional teams for quality issues.
  • Establish or revise assigned internal SOPs/Guidelines applicable to internal functions as well as outsourced functions to ensure compliance to cGMP.
  • Ensure compliance with the Quality Systems such as change control, quality investigations, and CAPA resolutions.  Management of assigned QA operation tasks in accordance to SOPs.
  • Perform QA audits/inspections (internal and external) as assigned.
  • Represent QA in multi-departmental meetings & project teams.
  • Manage, oversee, develop, if applicable, and/or contract support personnel..

Qualifications

  • Bachelor of Arts/Sciences (BA/BS) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
  • 5+ years’ experience in a cGMP regulated environment, with exhibited knowledge or proficiency in Quality Assurance.
  • Organizational and management skills to communicate to multi-discipline project groups. Ability to speak, present data, and defend approaches in front of audiences and inspectors.
  • Proficiency with Office software applications, including MS Word, MS Excel, MS Project, MS Power Point.
  • Proficiency with technical summary report reviews required, with exceptional organizational attention to detail.
  • Knowledge of industry standards, guidance documents, and global regulatory requirements from Phase I to Phase III is required.

.
 

 

It is our business imperative to remain a very inclusive workplace.

 

To our veterans and separated service members, you're at the forefront of our minds as we recruit top talent to join Nestlé. The skills you've gained while serving our country, such as flexibility, agility, and leadership, are much like the skills that will make you successful in this role.  In addition, with our commitment to an inclusive work environment, we recognize the exceptional engagement and innovation displayed by individuals with disabilities.  Nestlé seeks such skilled and qualified individuals to share our mission where you’ll join a cohort of others who have chosen to call Nestlé home.

 

The Nestlé Companies are an equal employment opportunity and affirmative action employer seeking diversity in qualified applicants for employment.  All applicants will receive consideration for employment without regard to race, ethnicity, color, gender, gender identity, age, religion, national origin, ancestry, disability, perceived disability, medical condition, genetic information, veteran status, sexual orientation, or any other protected status, as defined by applicable law. Prior to the next step in the recruiting process, we welcome you to inform us confidentially if you may require any special accommodations in order to participate fully in our recruitment experience. Contact us at accommodations@nestle.com or please dial 711 and provide this number to the operator: 1-800-321-6467.

 

This position is not eligible for Visa Sponsorship.

 

 

Brisbane, CA, US, 94005

Brisbane, CA, US, 94005


Nearest Major Market: San Francisco
Nearest Secondary Market: Oakland

Apply now »