Quality Assurance Manager

Andover, Massachusetts
Jul 30, 2021
Required Education
Bachelors Degree
Position Type
Full time


Working as a partner with Operations, QC, EMU, Planning and STS the Building A Suite AB Quality Manager is accountable for all activities required to disposition product and ensure overall compliance of all processes included in the Suite A/B Asset.  Additionally, is accountable for the assurance that all activities related to processing, and disposition for the product(s) is/are in full compliance with government regulations and internal company standards and values.  Strong communications skills are needed to be successful in this role


  • Leads the efforts of QA personnel responsible for the monitoring, testing, and disposition of the product in compliance with all regulatory requirements, company policies, values, and goals
  • Responsible for quality record review such as investigations, CAPAs, Change Controls.
  • Partners with other QA managers to ensure consistency and efficiency within the QA department.
  • This position requires strong collaboration skills, working with the network and Prevnar product team to ensure supply of Poly.
  • Decision maker for compliance and quality issues and documentation such as investigations, protocols, change controls, regulatory filings, etc.
  • Responsible to the asset for GMP compliance of the Suite AB manufacturing facility as well QA shift support for all assets
  • Participates in the recruitment, selection, promotion, termination, and performance management of QA employees
  • Partners with the Asset Team (Operations, Engineering, Technical Services and Supply Chain) to provide feedback on performance of non-Quality personnel.
  • Partners with the Asset Team for cross-functional management staff to evaluate production process needs, resolve problems and obstacles, provide resources. Reset direction and maximize effective interactions and functioning using IMEX to drive performance


  • BS or BA degree (Chemistry, Engineering, Biology, Manufacturing Management)
  • 12 plus years experience in pharma/biopharma industry, 5+ years management experience
  • Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. 


  • Experience in QA and/or Manufacturing and/QC, experience dealing with Regulatory compliance. Experience in problem solving, process improvement, negotiations and supervision


  • Ability to gown and enter the manufacturing Suite as needed


  • 24/7 support of manufacturing as quality issues arise
  • Some travel may be required but expected to be minimal.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations.  These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure.  Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act.  Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government.  If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Pfizer is an E-Verify employer.

Quality Assurance and Control