Sr. Site Quality Authority (SQA), Investigations & Compliance

About this role

Use Your Power for Purpose Everything we do every day is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based quality culture is both flexible and innovative, always putting the customer first. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that every step we take is aligned with our mission to improve patient outcomes. Join us in our mission to make a difference in the lives of patients through your expertise and dedication.

What You Will Achieve

In this role, you will: • Overseeing GMP manufacturing investigations, including review and approval of investigations, interim reports, commitments, and complex deviation records. In addition, to any other GMP documentation such as validation & qualification reports, procedures.  • Be responsible for performing thorough, detailed, and timely investigation reviews and approvals. • Drive timely investigation closure, promote robust root-cause analysis and human-error reduction practices, and partners cross-functionally with Manufacturing, Laboratory, Engineering, Analytical Technology, and Quality groups to maintain established compliance standards, support supply performance, and continually improve investigation processes. • Review, edit, approve, and/or directly support investigations, interim reports, commitments, and associated actions to drive timely and compliant closure. • Accountable for driving investigations to closure by reviewing and editing investigations, interim reports, and commitments that meet the established compliance standards and timelines. • Assist in continually defining and improving the philosophy tools for investigations to meet changing business needs. • Use knowledge of manufacturing processes and systems to evaluate process deviations, atypical results, and complex investigations with appropriate scientific and compliance rationale. • Coordinate and facilitate investigation meetings, lead technical discussions, influence cross-functional teams, and build consensus with multiple stakeholders. • Have a fundamental understanding of the investigation process as it applies to manufacturing and laboratory issues. • Partner with Operations, Laboratory, Engineering, Analytical Technology, Manufacturing, Quality, other PGS sites, center functions, and Pharm-Sci to support investigations, new product/technology transfer activities, and continuous improvement. • Drive or contribute to complex projects and team milestones/deliverables, exercising independent judgment under limited supervision. • Promote consistent application of root-cause analysis, human-error reduction tools, and investigation process improvements to meet changing business needs. • Exercises own judgement leveraging knowledge and experience with minimal assistance from Management • Provides peer leadership to mentor and develop other colleagues • Upkeep and development of department SOPs, monitoring alignment with regulations and Pfizer Quality Standards

Here Is What You Need (Minimum Requirements) • BA/BS with at least 4 years of experience or MBA/MS with at least 2 years of experience or PhD/JD with any years of experience or Associate's degree with at least 8 years of experience or High School Diploma (or Equivalent) with at least 10 years of relevant experience • Demonstrated effective team-building skills • Strong oral and written communication abilities • Proficiency in deviation management systems • Experience with six sigma methodologies • Strong analytical and problem-solving skills • Experience in Quality and/or Compliance with working knowledge of Good Manufacturing Practices (GMPs). • Demonstrated ability to solve problems, manage priorities, make decisions independently, and work under limited supervision. • Experience with electronic quality and business systems such as eQMS, QTS, Sherlock, PDOC’s, LIMS, SAP, MS Word, and MS Excel.  

Bonus Points If You Have (Preferred Requirements) • Master’s degree coupled with relevant pharmaceutical experience • Proficiency in M1 and PHP • Background in continuous improvement methodologies such as Green or Black belt certification • Robust understanding of GMP Manufacturing, QA/QC, Aseptic Manufacturing, and Environmental Monitoring • Experience coordinating/facilitating meetings, leading conversations, influencing teams, and communicating effectively with multiple stakeholders. • Experience with FDA and EU licensing and inspection activities, technology transfer, and project management.

• Demonstrated leadership capability including developing/coaching colleagues, guiding work of others, and creating meaningful business impact. • Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

  PHYSICAL/MENTAL REQUIREMENTS Sitting, standing, walking, ability to perform mathematical calculations, ability to perform complex data analysis, and ability to work periodically on the manufacturing floor with heightened safety awareness. Aseptic gowning may be required when entering applicable manufacturing areas.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS • Onsite or flex schedule, as aligned with site/business requirements. • Core business hours are generally 8:00 a.m.–5:00 p.m.; occasional evening, weekend, or holiday work may be required to support operations, investigations, or commitments. • No routine travel expected; occasional travel may be required (0–10%). • Position may require work on the manufacturing floor and adherence to applicable safe work practices and aseptic gowning requirements.

Work Location

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