Principal Scientist: ARD Compliance Lead

Use Your Power for Purpose At Pfizer, our purpose is to deliver breakthroughs that change patients’ lives. Your role will be pivotal in translating advanced science and technologies into impactful therapies and vaccines, ultimately improving patients' lives. What You Will Achieve Support the delivery of ARD compliance, instrumentation, and GMP data processes including data integrity strategy. This matrixed role will interface across ARD and with our strategic partners to ensure compliance with applicable procedures and policies and the implementation of robust GMP data processes. You will: Interact effectively with highly interdisciplinary teams in a cross‑functional environment. Enhance the overall quality culture and maintain an audit and inspection‑ready state. Proactively drive departmental initiatives to improve data integrity, quality, and compliance. Represent ARD in the ARD Quality Council and other quality leadership efforts. Lead CAPA management, eQMS support, vendor support, instrument validation lifecycle support and other compliance responsibilities. Implement continuous improvement initiatives in data review, specification review, instrument systems, and ARD project team interfaces with GMP functions. Assist teams in bridging technical needs with quality requirements at the interface of ARD laboratory quality systems. Manage compliance‑related metrics and optimize implementation of Pfizer Revolution processes that impact ARD. Coordinate audit and inspection readiness training, audit coordination, CAPA resolution, and timely response to audit activities. Support data integrity efforts and partner with laboratory personnel for remediation. Contribute to GA involvement in AMTE unit of work, including engagement and implementation of updated Revolution AMTE processes. Qualifications Must Have BA/BS with at least 12 years of experience, MBA/MS with at least 9 years of experience, or PhD/JD with 4–8 years of experience in a quality or compliance field. Experience with data integrity approaches and instrument qualification strategy. Experience in a regulated environment (e.g., GLP, cGMP). Strong technical skills and scientific expertise in equipment validation. Proven record of delivering results in a fast‑paced environment and effective communication with project teams and external partners (e.g., regulatory authorities). Familiarity with technologies focused on the analysis of biomolecules and conjugates. Demonstrated technical writing and presentation skills. Exemplary leadership behaviors and the ability to collaborate with and mentor others. Proficiency in general analytical techniques and knowledge of quality management systems. Experience in strategic planning and resource management in fast‑paced, multi‑tasking environments. Nice to Have Direct experience working with auditors or inspectors (e.g., FDA, European regulatory authorities). Experience in GMP environment and implementation of continuous improvement practices. Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Curiosity for exploring how these tools can improve outcomes and an understanding of responsible AI practices, including risk management and ethical use. Compensation Annual base salary ranges from $106,000.00 to $176,600.00. Eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility for a share‑based long‑term incentive program. Benefits Comprehensive and generous benefits including a 401(k) plan with matching contributions, paid vacation, holidays, personal days, paid caregiver/parental and medical leave, and health benefits covering medical, prescription drug, dental and vision coverage. Relocation Support Relocation assistance may be available based on business needs and/or eligibility. Work Location Assignment: On Premise. Eligibility This position requires permanent work authorization in the United States; U.S. work visa sponsorship is not available for this role now or in the future. EEO & Employment Eligibility Pfizer is committed to equal opportunity in all 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 complies with all applicable laws governing nondiscrimination and work authorization verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E‑Verify employer and this position requires permanent U.S. work authorization. #J-18808-Ljbffr