QA Manager, Site Investigation Lead (Secondment - 6 Months)

WHY PATIENTS NEED YOU

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients.

WHAT YOU WILL ACHIEVE

In this role, you will:

  • Conduct detailed analysis of KPIs, collaborating cross-functionally to identify process gaps and initiate improvement strategies aligned with quality and production target.

  • Lead statistical trending of deviations and investigations to uncover systemic issues and inform proactive risk mitigation.

  • Initiate and oversee continuous improvement projects based on data trends, leveraging Lean and Six Sigma methodologies to streamline operations and reduce recurrence.

  • Make decisions to resolve moderately complex problems, develop new options guided by policies, and operate independently in ambiguous situations.

  • Utilize judgment and experience to potentially become a resource for others, and evaluate clinical and commercial drug batches to ensure adherence to specifications.

  • Identify deviations in manufacturing and packaging processes, approve investigations and change control activities, and guide operational teams in project management.

  • Prepare forecasts for resource requirements, identify areas for improvement, and facilitate agreements between different teams using leadership skills.

  • Assess supplier operations for regulatory compliance, conduct quality reviews, and report results to relevant medical and quality groups.

  • Support the development of country quality strategic initiatives, lead continuous inspection readiness, and drive effective management of quality issues and CAPAs.

  • Participate in internal cGMP audits, support regulatory inspections, perform disposition of clinical trial materials, and communicate with internal and external customers to resolve project-related issues.

  • Ensure effective internal networking to develop and maintain business partner relationships with internal colleagues.

QUALIFICATIONS

Must-Have

  • Applicant must have a bachelor's degree with at least 5+ years of experience; OR a master's degree with at least 3+ years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8+ years of experience; OR a high school diploma (or equivalent) and 10+ years of relevant experience.

  • Substantial experience in pharmaceutical manufacturing and quality control.

  • Familiarity with Current Good Manufacturing Practices (cGMP) and handling compliance issues arising from cGMP deviations or product defects.

  • Knowledge of regulations related to vendor management programs and other industry quality systems.

  • Strong critical thinking skills and a proactive approach.

  • Ability to collaborate effectively, manage relationships, and communicate well both in writing and verbally.

  • Advanced computer skills in MS Office applications and a good understanding of enterprise systems such as PDM, Veeva Vault, Quality Tracking System Trackwise, LIMS, SAP and Documentum platforms.

Nice-to-Have

  • Experience in Quality Systems in pharmaceutical, medical device, or combination product industry.

  • Knowledge or exposure to data science.

  • Strong leadership and team management skills.

  • Ability to work under pressure and meet tight deadlines.

  • Ability to influence and negotiate with stakeholders.

  • Experience in conducting internal audits and supporting regulatory inspections.

  • 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.

OTHER JOB DETAILS

  • Last Date to Apply for Job: July 22, 2026

  • Additional Location Information: NA

  • Eligible for Relocation Package – NO

  • Secondment 6 months

  • If you are currently in a driving position with a fleet vehicle and this secondment does not require driving as an essential function of the position for 12 months or longer, you will be required to turn in your fleet vehicle for the duration of the non-driving secondment. Please refer to the Fleet Policy and Procedures document for more information.

  • There will be no change to your current work location.

  • Position is considered Flexible, and colleagues are expected to comply with Log In For Your Day (LIFYD) requirements at site location (e.g. about 2.5 days a week in office).








Relocation assistance may be available based on business needs and/or eligibility.




Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.




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, 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. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.

Pfizer endeavors to make www.pfizer.com/careers accessible to all users. 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.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.




To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.


Quality Assurance and Control