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

The Sr. Site Quality Authority (SQA), Investigations & Compliance role oversees GMP manufacturing investigations, including review and approval of investigations, interim reports, commitments, and complex deviation records.

The role drives timely investigation closure, promotes 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.

Responsibilities

• 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 PharmSci 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.

Basic Qualifications

• Bachelor’s degree with at least 4 years of relevant experience; OR master’s degree with at least 2 years of relevant experience; OR a PhD with 0+ years of relevant experience; OR an associate’s degree with 8 years of relevant experience; OR high school diploma/equivalent with 10 years of relevant experience.
• 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.

Preferred Qualifications

• 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.

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.

Salary and Benefits

• The annual base salary for this position ranges from $99,200.00 to $165,400.00.
• Eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share-based long-term incentive program.
• Comprehensive and generous benefits and programs to help colleagues lead healthy lives and support each of life’s moments.