QA Manager

** Use Your Power for Purpose **

Everything we do is driven by our commitment to delivering safe and effective products to patients. The QA Manager helps sustain Our science- and risk-based compliant quality culture that is compliant, flexible, innovative, and customer focused. Whether you are supporting development, maintenance, compliance, validation, manufacturing, laboratory testing, or quality systems, your contribution is critical and has a direct impact on patients. Our commitment to quality and safety helps ensure we consistently meet the highest standards and make a meaningful difference for those we serve.

  What You Will Achieve

The QA Manager is part of the Pharmaceutical Sciences Operations Quality (PSOQ) team based at the Andover, MA site. This role provides Quality Assurance support and oversight for GMP operations, including clinical manufacturing, GMP laboratory testing, validation, and related quality systems. The position partners cross-functionally with manufacturing, laboratory, engineering, validation, and quality colleagues to ensure compliant execution of activities and maintain continuous inspection readiness.

** Primary Responsibilities include:   **

• Provide Quality Assurance oversight for GMP operations, including clinical and /commercial cell banks, clinical drug substance, clinical drug product, and validation activities, for Pharmaceutical Sciences facilities.

• Review and approve GMP documentation, including batch records, investigations, change controls, CAPAs, commitments, SOPs, test methods, laboratory data, validation protocols/reports, trend reports, and other quality records.

• Provide quality oversight for the Pharmaceutical Sciences validation program, including facilities, utilities, manufacturing and laboratory equipment, instruments, and computer systems.

• Review and approve validation lifecycle documentation, including maintenance, calibration, vendor assessments, data integrity assessments, requalification, and decommissioning activities.

• Perform disposition of clinical materials; support document review, final material release, raw material release, and clinical manufacturing operations as needed.

• Participate in QA observation of the drug product media fill program.

•  Support internal audits, external audits, and regulatory inspections.

• Manage quality issues, investigations, and CAPAs through sound judgment, risk-based decision making, timely resolution, and appropriate escalation.

• Support quality oversight for technology transfers, new program introductions, manufacturing technologies, quality risk management, and GMP facility certification activities.

• Contribute to Quality Assurance management team initiatives and act in accordance with Pfizer’s values.

• This position does not include the management of direct reports.

• This position is based at the Andover, MA Pfizer location.

• This individual contributor role

** How You Will Achieve It   **

• Drive Quality Assurance Validation strategy, planning, and continuous improvement activities to support compliant, risk-based execution across the network.

• Evaluate operations, procedures, equipment, computerized systems, and quality records for compliance with regulations, Pfizer Quality Standards, and site procedures.

• Maintain inspection readiness by identifying gaps, supporting audit preparation, and driving timely completion of commitments and corrective actions.

• Manage equipment and computer system quality lifecycles from onboarding through decommissioning, including data integrity and electronic records expectations.

• Communicate effectively, present to peers and management, influence cross-functional partners, and maintain strong internal and external business relationships.

• Prioritize competing responsibilities, make sound quality decisions, recognize issues beyond the role’s scope, and escalate appropriately.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years ofrelevant experience

• Relevant pharmaceutical manufacturing, quality assurance, validation, laboratory operations, or GMP experience.

• Team player with strong interpersonal, organizational, collaboration, relationship management, and written/verbal communication skills.

• Self-motivated, engaged, proactive, and able to perform moderately complex tasks independently.

• Strong critical thinking skills with the ability to resolve issues, problem solve and recommend solutions.

• Proficiency with MS Office applications and enterprise quality/document systems such as Veeva Quality Management System (eQMS), EMD365, and Documentum platforms.

Bonus Points If You Have (Preferred Requirements)

• Biopharma industry experience, including a good understanding of FDA and international regulatory requirements for Aseptic drug product manufacturing and testing preferred.

• A microbiological background is desirable.

• Science, Engineering, or Technical field of study preferred.

 **

PHYSICAL/MENTAL REQUIREMENTS**

• Mental agility to manage a large quantity and broad scope of quality assurance work.

• Ability to work independently, solve problems, and recommend solutions.

• Role is primarily office-based. Position requires walking, sitting, standing, and carrying batch records from one location to another, as the Andover site is a campus setting.

• Able to lead and/or participate in in-person or Teams meetings.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Role is a standard daytime 40-hour work week.

• Adherence to Pfizer safety practices is a must.

• It is not anticipated that this role will require business travel but it would be minimal if needed.

**Work Location Assignment: On Premise

The annual base salary for this position ranges from $99,200.00 to $165,400.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

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.  This position requires permanent work authorization in the United States.

Pfizer endeavors to make   www.pfizer.com/careers   accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email   disabilityrecruitment@pfizer.com . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on  Pfizer Careers .

Quality Assurance and Control