Use Your Power for Purpose
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
Candidate is responsible for providing Quality Assurance oversight to GMP
manufacturing and testing operations relative to commercial cell bank manufactured in the Andover Cell Bank Facility (ACBF), clinical drug substance manufactured within the Pfizer Andover Clinical Manufacturing Facility (ACMF) and clinical drug product manufactured in the Andover Liquid Dose Manufacturing Facility (AN-LDM). This includes quality oversight to tech transfer of new programs, new manufacturing technology and support of GMP facility certification. The candidate will also support disposition deliverables such as review of batch records, investigations, CAPAs, SOPs, test methods, including the release of the drug substance material.
This position does not include the management of direct reports.
This position is based at the Andover, MA Pfizer location. This role is part of the Pfizer Global Biotherapeutics Quality organization and will work closely with quality, manufacturing and laboratory lines. This position is responsible for
assuring compliance with Pfizer Quality Standards and governmental regulatory requirements.
How You Will Achieve It
Provide guidance, lead/co-lead projects/manufacturing campaigns, manage own time to meet objectives, plan resource requirements for projects across the Department.
Participate on technology transfer teams reviewing and approving master batch records and manufacturing related documentation.
Participate/Lead continuous improvement initiatives
Provide review of equipment/instrument validation documentation and related
calibration documentation, as needed.
Lead continuous inspection readiness for Quality Assurance.
Drive effective management of quality issues and Corrective Action Plan (CAPAs) and make decisions that may involve complex quality and technical issues.
Participate in internal Good Manufacturing Practices {also cGMP} audits and
support regulatory inspections or corporate audit activities.
Perform disposition of clinical trial materials.
Support Raw material release as needed
Communicate with and influence internal and external customers across site and department boundaries to ensure compliant and aligned resolution of project related issues and investigations.
Ensure appropriate internal networking to develop and maintain close and effective
business partner relationship with internal colleagues.
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 of relevant experience
Pharmaceutical manufacturing/Quality experience
Experience in clinical manufacturing operations/Media Fill observations
Current Good Manufacturing Practices experience with compliance issues resulting from cGMP deviations or product defects, regulations as related to vendor management programs and other industry quality systems and processes
Proactive approach and strong critical thinking skills
Strong collaboration, relationship management, and interpersonal skills.
Excellent written and verbal communication
Advanced computer skills in MS Office applications and good knowledge of
enterprise systems, such as Veeva Quality Management System (eQMS), EMD365, and Documentum platforms.
Bonus Points If You Have (Preferred Requirements)
Experience in Quality Systems in pharmaceutical, medical device, or combination product industry
Knowledge or exposure to and data sciences
PHYSICAL/MENTAL REQUIREMENTS
Mental agility to handle a large quantity and broad scope of different types of quality assurance work.
Ability to work independently, problem solve and make recommendations for solutions.
Role is primarily office-sitting. Position requires walking, sitting, standing, and carrying batch records from one location to another as 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
Shift is 1st, Monday - Friday, typically 8am -5pm, availability to work off shift hours, weekends and Holidays as needed.
OTHER JOB DETAILS
Last Date to Apply for Job: Nov 10, 2025.
Referral Bonus Eligibility: YES
Eligible for Relocation Package: No
Work Location Assignment: On Premise
Relocation assistance may be available based on business needs and/or eligibility.
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.