Medical Regulatory Affairs Associate

Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.

The Manufacturing Quality Operations Senior Associate provides Quality Assurance (QA) support to all modalities manufactured on site including clinical, commercial, and contract manufacturing operations providing QA Operations Floor oversight. The role ensures adherence to regulatory expectations, safety, and GxP (i.e., Duties include, but are not limited to, Aseptic Observations, batch record review, line clearance approvals, alarms evaluation, on the floor triage, and on the floor real time batch record review. The Senior Associate will work cross-functionally with manufacturing and support groups to investigate manufacturing events, and support site internal and external regulatory inspections. The role is based at the Pfizer Sanford, NC Pfizer Global Supply (PGS) site and provides on-call, after hours and weekend support to ensure no interruptions of 24 / 7 operations.

BA / BS degree in Microbiology, Chemistry, Biological Sciences, Bioengineering (preferred) with 2+ years of experience OR MBA / MS degree in Microbiology, Chemistry, Biological Sciences, Bioengineering (preferred) with any years of relevant experience OR Associate’s degree in Microbiology, Chemistry, Biological Sciences, Bioengineering (preferred) with 6+ years of experience OR High school diploma (or equivalent) with 8+ years of experience

Fundamental knowledge of the principles and concepts of current Good Manufacturing Practices (cGMPs) used in the Pharmaceutical Industry. Knowledge of, and experience in a biopharmaceutical / pharmaceutical cGMP environment

Knowledge of electronic systems including Trackwise, Documentum / PDOCs, SAP, gLIMS, Microsoft Office.

Good judgment and correct decision making based on company procedures / standards, technical experience, and industry guidance / regulatory requirements

Good working knowledge of Microsoft Excel and Word

Bonus Points If You Have (Preferred Requirements)

Experience in quality administered systems

Experience with regulatory compliance and documentation

Non-Standard work schedule, travel or environment requirements

~ Limited travel, no more than 5%, if required.

In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary. 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.Pfizer compensation structures and benefit packages are aligned based on the location of hire. Relocation assistance may be available based on business needs and / or eligibility.

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

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.This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and / or interviewing. Quality Assurance and Control