GMP Investigation Lead

Use Your Power for Purpose

Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need when they need them. Your contributions will be vital in achieving project tasks and goals, fostering a collaborative team environment, and enabling Pfizer to reach new milestones and provide aid to patients worldwide.

What You Will Achieve

In this role, you will:

• Lead and author GMP investigations within Pfizer quality systems for manufacturing deviations, product quality excursions, equipment and facility events, and compliance-related observations.
• Conduct thorough fact-finding, data collection, and technical assessments utilizing manufacturing records, process data, laboratory data, audit trails, equipment histories, and enterprise systems.
• Facilitate cross-functional investigation teams to identify root causes using structured problem-solving methodologies and quality risk management principles.
• Partner with Manufacturing, Quality Assurance, Process Development, Engineering, Validation, and Analytical teams to determine event impact, product disposition requirements, and corrective/preventive actions.
• Drive investigations to completion while ensuring quality, regulatory compliance, and adherence to established timelines.
• Evaluate investigation trends and support continuous improvement initiatives aimed at reducing repeat events and improving manufacturing robustness.
• Support internal and external audits, regulatory inspections, and quality system assessments as required.
• Contribute to additional quality and compliance initiatives, including audit responses, CAPA effectiveness evaluations, risk assessments, and procedure development.

Qualifications

Must Have

• Bachelor's degree with 0 to 2 years of relevant experience, or an Associate's degree with 4 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience
• Strong technical writing and documentation skills with demonstrated ability to author complex GMP records
• Experience in a GMP biotechnology manufacturing or laboratory environment
• Ability to analyze technical data, identify trends, and present clear, evidence-based conclusions.
• Excellent organizational and project management skills with the ability to independently manage multiple priorities and deadlines.

Nice to Have

• Commitment to continuous improvement and operational excellence
• 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.
• Experience authoring and leading cGMP manufacturing investigations, deviations, CAPAs, and quality event records.
• Working knowledge of biologics manufacturing processes including cell culture, purification, filtration, formulation, and supporting utilities.
• Familiarity with quality risk management and root cause analysis tools such as Fishbone, 5-Why, FMEA, Fault Tree Analysis, or similar methodologies.
• Experience utilizing manufacturing and quality systems including DeltaV, SAP, Microsoft Dynamics, LIMS, electronic batch records, document management systems, and data historian platforms.
• Experience supporting regulatory inspections, internal audits, and inspection readiness activities.

PHYSICAL/MENTAL REQUIREMENTS

• Ability to perform mathematical calculations and complex data analysis
• Ability to gown into/out of manufacturing clean rooms

The annual base salary for this position ranges from $60,200.00 to $100,400.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary. 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.