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

ROLE SUMMARY
The Sr. Site Quality Authority (SQA), Investigations & Compliance role provides is responsible for 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. The candidate will be responsible for performing thorough, detailed, and timely investigation reviews and approvals.
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.
ROLE 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.
The annual base salary for this position ranges from $99,200.00 to $165,400.00. In addition, this position is 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. 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.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
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, di

Skills
Data Analysis, Excel, Project Management, Talent Acquisition, SAP, Documentation