Quality Assurance Manager

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.

You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer’s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

As a Manager, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services. Your will guide projects by meeting objectives and preparing forecasts for resource requirements. Your risk-taking ability will help us advance new concepts and methodologies. You will provide technical guidance and oversight to team members and help in problem solving.

• Leads the efforts of QA personnel responsible for the testing, investigations, and method transfer activities to ensure compliance with all regulatory requirements, company policies, values, and goals.
• Responsible for quality record review such as investigations, CAPAs, Change Controls and other quality documents as required.
• Responsible for driving process improvements within Drug Substance, Drug Product, Site support systems.
• Actively drives with urgency when necessary to resolve issues related to production or supply as it relates to investigations or other issues.
• Responsible for driving cross-training across Drug Substance, Drug Product, Site staff resources (as well as potentially other areas of QA).
• Responsible for inspection support and SME for QA QC Site department as required.
• Partners with other QA managers to ensure consistency and efficiency within the QA department.
• This position requires strong collaboration skills, including working with Pharm Sci QA, Quality Control, Engineering, Site Technical Services, other Pfizer sites, and others to ensure timelines are met for activities related to Quality Control and the Site.
• Decision maker for compliance and quality issues and documentation such as investigations, protocols, change controls, regulatory filings, etc.
• Participates in the recruitment, selection, promotion, termination, and performance management of QA employees
• Other duties as required.

• BS or BA degree (Chemistry, Engineering, Biology, Manufacturing Management)
• 12 + years experience in pharma/biopharma industry, 1+ years management experience

Nice-to-Have

• Experience in QA and/or Manufacturing and/QC, experience dealing with Regulatory compliance. Experience in problem solving, process improvement, negotiations and supervision
• Master's degree
• Knowledge of device/combination product industry regulations

Relocation support available

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.