Manager Quality Assurance

Pfizer • Sanford, NC

2d • Onsite

About The Position

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 In this role, you will: Lead and guide moderately complex projects, managing time and resources effectively, and apply skills and discipline knowledge to departmental work. 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 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. Apply broad and in-depth GxP knowledge to interpret cGxP requirements across commercial and clinical environments, independently reviewing and shaping global procedures and working instructions to ensure regulatory compliance and business value. Oversee and manage all site batch disposition activities for Monoclonal Antibodies and Vaccine drug substance and drug substance intermediates. Lead and develop a QA team responsible for batch record review and disposition, COA/COC issuance, lot release protocols, APRRs, regulatory submission query responses, and QA warehouse support to enable compliant material flow and release readiness. Own planning and execution to meet objectives, plan-of-record deliverables, and project milestones by actively managing resources, priorities, and timelines. Drive quality strategic initiatives and continuous improvement, implementing new processes and applying best practices aligned to risk, compliance expectations, and business needs. Serve as a QA technical authority, independently resolving complex quality, technical, and compliance issues; making sound, risk‑based decisions that may impact product disposition, supply commitments, and project timelines. Provide expert leadership support in investigations, including SME support of complex investigations, interpretation of data and trends, and development of clear conclusions and next steps. Coach, mentor, and train colleagues, strengthening team capability in batch release and quality decision‑making practices. Partner cross‑functionally with Supply Chain, Manufacturing, QC, Investigations, Project Management, and global stakeholders to ensure market supply, clinical timelines, and inspection readiness. Represent Quality Assurance in cross‑functional, cross‑site, and cross‑network forums, serving as the Quality SME empowered to speak on behalf of the function and provide strategic input. Assess internal and external regulatory compliance, support inspection readiness, and proactively anticipate, communicate, and escalate issues to appropriate management when needed. Demonstrate strong judgment, open communication, and effective collaboration, knowing when broader multidisciplinary engagement or escalation is required.

Requirements

• 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.
• 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 SAP, LIMS, Veeva Vault and other Quality Management Systems, and Documentum platforms.
• Permanent work authorization in the United States.

Nice To Haves

• Experience in Quality Systems in pharmaceutical, 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.

Responsibilities

• Lead and guide moderately complex projects, managing time and resources effectively, and apply skills and discipline knowledge to departmental work.
• Make decisions to resolve moderately complex problems, develop new options guided by policies, and operate independently in ambiguous situations.
• Evaluate clinical and commercial 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.
• Apply broad and in-depth GxP knowledge to interpret cGxP requirements across commercial and clinical environments, independently reviewing and shaping global procedures and working instructions to ensure regulatory compliance and business value.
• Oversee and manage all site batch disposition activities for Monoclonal Antibodies and Vaccine drug substance and drug substance intermediates.
• Lead and develop a QA team responsible for batch record review and disposition, COA/COC issuance, lot release protocols, APRRs, regulatory submission query responses, and QA warehouse support to enable compliant material flow and release readiness.
• Own planning and execution to meet objectives, plan-of-record deliverables, and project milestones by actively managing resources, priorities, and timelines.
• Drive quality strategic initiatives and continuous improvement, implementing new processes and applying best practices aligned to risk, compliance expectations, and business needs.
• Serve as a QA technical authority, independently resolving complex quality, technical, and compliance issues; making sound, risk‑based decisions that may impact product disposition, supply commitments, and project timelines.
• Provide expert leadership support in investigations, including SME support of complex investigations, interpretation of data and trends, and development of clear conclusions and next steps.
• Coach, mentor, and train colleagues, strengthening team capability in batch release and quality decision‑making practices.
• Partner cross‑functionally with Supply Chain, Manufacturing, QC, Investigations, Project Management, and global stakeholders to ensure market supply, clinical timelines, and inspection readiness.
• Represent Quality Assurance in cross‑functional, cross‑site, and cross‑network forums, serving as the Quality SME empowered to speak on behalf of the function and provide strategic input.
• Assess internal and external regulatory compliance, support inspection readiness, and proactively anticipate, communicate, and escalate issues to appropriate management when needed.
• Demonstrate strong judgment, open communication, and effective collaboration, knowing when broader multidisciplinary engagement or escalation is required.

Benefits

• 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
• Health benefits to include medical, prescription drug, dental and vision coverage
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: High school or GED