Site Compliance Lead

Pfizer • Sanford, NC

11d • Onsite

About The Position

At Pfizer, quality protects patients and enables reliable supply. As the Site Compliance Lead, you’ll ensure site cGMP activities align with Pfizer Quality Standards and regulatory requirements partnering across Quality and Operations to strengthen inspection readiness, audits, data integrity, and proactive risk management. What You Will Achieve In this role, you will: Own and drive the site inspection readiness strategy and execution, ensuring a sustained state of compliance and rapid escalation/containment when needed. Lead site preparation for, execution of, and follow-up from external audits/inspections (health authorities/Board of Health, customer, and internal corporate audits), including response coordination and lessons learned. Lead the internal audit program to assess ongoing cGMP compliance and drive continuous improvement actions. Provide leadership and governance for the site Data Integrity program. Own site Quality Risk Management processes, including establishing/maintaining the site risk register and leveraging quality system signals to reduce risk. Coordinate Management Review by leading routine Site Quality Review Team (SQRT)/quality council cadence, inputs, and outputs. Lead Annual Product Record Review (APRR) planning, execution, and reporting. Develop and lead a team (approx. 5–10 direct reports); set expectations, coach performance, and build quality capability across the organization.

Requirements

• BA/BS with 6+ years of experience or MBA/MS with 5+ years of experience.
• Demonstrated ability to lead cross-functional compliance programs and communicate effectively at all levels.
• In-depth knowledge and experience of pharmaceutical cGMP principles and concepts of relevant quality processes.
• Strong interpersonal and leadership skills, including the ability to positively influence and coach others.
• Ability to communicate complex information in both verbal and written formats.

Nice To Haves

• 5+ years of people leadership experience.
• Experience managing external audits/inspections (regulatory authorities/Board of Health, customer, and corporate audits) and coordinating inspection responses and lessons learned.
• Experience leading site inspection readiness programs and sustaining a continuous state of compliance.
• Experience leading site Data Integrity and Quality Risk Management programs, including establishing and maintaining a site risk register.
• Strengths aligned to the stated technical and behavioral competencies (e.g., Strategic & Innovative Thinking; Seizes Accountability; Holds People Accountable; Builds Change Agile Organizations; Commits to “One Pfizer”; Grows Leaders; Self-Awareness; Insight, Influence & Inclusion; Acts Decisively).

Responsibilities

• Own and drive the site inspection readiness strategy and execution, ensuring a sustained state of compliance and rapid escalation/containment when needed.
• Lead site preparation for, execution of, and follow-up from external audits/inspections (health authorities/Board of Health, customer, and internal corporate audits), including response coordination and lessons learned.
• Lead the internal audit program to assess ongoing cGMP compliance and drive continuous improvement actions.
• Provide leadership and governance for the site Data Integrity program.
• Own site Quality Risk Management processes, including establishing/maintaining the site risk register and leveraging quality system signals to reduce risk.
• Coordinate Management Review by leading routine Site Quality Review Team (SQRT)/quality council cadence, inputs, and outputs.
• Lead Annual Product Record Review (APRR) planning, execution, and reporting.
• Develop and lead a team (approx. 5–10 direct reports); set expectations, coach performance, and build quality capability across the organization.

Benefits

• participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees