Manager - PSOQ Clinical Complaints and Investigations

Pfizer•Groton, CT

2d•Hybrid

About The Position

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. ROLE SUMMARY 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 and Investigation management. Additional responsibility will also include being the Local Process Owner ( LPO) for clinical complaints, interfacing with the Global Process Owner (GPO) and process peers as appropriate, to meet investigational product requirements ensuring regulatory expectations are embedded, plus includes being the lead for the interface with PGS - Commercial complaints team. 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. What You Will Achieve In this role, you will: 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 , responsibilities pertaining to being the Local Process Owner for Clinical complaints 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:

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 a proactive 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.
This position requires permanent work authorization in the United States.

Nice To Haves

Knowledge of GCP regulations, principles, and concepts
Knowledge or exposure to data science
Strong leadership and team management skills
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

Responsibilities

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.
May be required to participate/ support PSQRT/AQRT activities and outcomes.
Local Process Owner /Lead for Clinical Complaints, ensuring Investigational Product (IP) needs are met and reflected, ensuring an IP fit for purpose model in the global documents.
Subject Matter Expert for the complaint process for PSOQ.
Accountable for the ownership, training, health, and continuous improvement (CI) of the Process Influence Global Process Owner (GPO) and process peers as appropriate, local needs & best practices and share local Regulatory Commitments for the Process, also ensuring regulatory expectations are embedded.
Lead Interface with PGS -PQC -Product Quality complaints (Commercial Complaints) Lead for PSOQ on the Complaint Council/ Governance with PGS Tracking and Trending local performance on global KPIs to measure Process effectiveness & mitigate risk at local level.
Audit/Inspection point of contact/ Lead, 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.
Support the development and management for Spotfire and SharePointplatforms, using these for data analysis, team documentation repository, plus as a communication tool.
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.

Benefits

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.

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