Manager - PSOQ Clinical Complaints and Investigations

USE YOUR POWER FOR PURPOSE

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 

This Quality position is considered a global position and reports into the Global Clinical Supply Quality Assurance (GCS QA) Lead for Clinical Complaints and Investigations, within Pharm Sci Operation Quality (PSOQ) responsible for supporting Pharmaceutical Sciences.

This Manager position will primarily support the GMP/GCP interface specialty team within GCS QA and may lead to opportunities to move or rotate into the wider areas of GCS QA in alignment with Development Planning and/or Business need.

This Manager will be responsible for leveraging strong and collaborative partnerships with colleagues across PSOQ, Global Clinical Supplies / Clinical Development Operations, other Worldwide Research and Development organizations and PGS to support the management for the following areas: Clinical Complaints, Investigation management, and Management Notification activities. Additional responsibility will also include supporting the Local Process Owner (LPO) for clinical complaints, to meet investigational product requirements ensuring regulatory expectations are embedded with relevant procedures.

In addition, would be required to support Inspection/Audit readiness, data analysis and development and management of Spotfire and SharePoint platforms, also responsible for developing and enhancing processes to continuously improve and streamline existing quality processes to support activities, with knowledge and skills contributing towards the goals and objectives of the team.

ROLE RESPONSIBILITIES

Perform a range of duties within the GCS QA Clinical Complaints and Investigation team, associated with Quality Management Systems oversight, Quality Operational role for Clinical Complaints,  Investigations , Management Notification  and may be required to support Inspection/Audit  readiness , for which Duties may include some or all the following, at various times, depending on experience and job assignment:

• Responsible for leading /supporting the author, review, and approval of related moderately complex GMP deviations & product quality investigations and provide oversight to the timely closeout and effective investigation of clinical supplies, CAPA effectiveness, trending, and metrics.

• Responsible for leading /supporting the author, review, and approval of moderately complex clinical complaints, ensuring timely closeout, providing complaint management oversight for trending and metrics, CAPA effectiveness.

• Escalate issues as appropriate to the Quality Assurance Lead in a timely manner, with responsibilities for generating Notifications to Management/ Issue Escalations.

• Perform Management Notification activities, and May be required to participate/ support PSQRT/AQRT activities and outcomes.

•  Support the Local Process Owner for Clinical Complaints, ensuring Investigational Product (IP) needs are met and reflected, ensuring an IP fit for purpose model in the global documents.

• Tracking and Trending of metrics to measure Process effectiveness & mitigate risk at local level.

• Audit/Inspection support, collaborate with Global Clinical Supply, PharmSci Operation Quality and other groups in Worldwide Research and Development to support Regulatory agency inspections, Regulatory Quality Assurance, and Internal audits / Inspections.

• Applies skills and knowledge to Support continuous improvement, special projects and limited duration teams in the support model and management of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) activities for the investigational medicinal product process through partnerships with Global Clinical Supply and the wider Clinical Development Operations.

• Takes appropriate risks to Streamline compliance and simplify procedural and other requirements to ensure ease of following program requirements.

• lead quality risk management efforts in all areas/ disciplines within the team.

• Able to operate independently in ambiguous situations.

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

• Takes responsibility for a portion of the Team’s milestones/deliverables.

 

HERE IS WHAT YOU NEED (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 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.

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

• Knowledge of regulations related to investigational Products and industry quality systems.

• Strong critical thinking skills and an initiative-taking approach.

• Proven leadership, accountability, and demonstrated excellent interpersonal, listening, communication, negotiation, influencing, organizing and problem-solving capabilities.

• Capable of managing multiple complex projects with a keen sense of business acumen.

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

• Demonstrated experience in supporting continuous improvement projects.

• Proven ability to function autonomously in a matrix model and in a team environment.

BONUS POINTS IF YOU HAVE (Preferred Requirements)  

• Knowledge of GCP regulations, principles, and concepts.

• Knowledge or exposure to data science.

• Ability to influence and negotiate with stakeholders.

• Ability to adapt to changing priorities and manage multiple tasks simultaneously.

• Experience in supporting internal audits and 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

Work Location Assignment: Hybrid

Last Date to Apply for Job: May 14, 2026

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.

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.

Quality Assurance and Control