Senior Manager, ARD Compliance

Pfizer • St Louis, MO

4d • Onsite

About The Position

The ARD Compliance Lead is a strategic people leader responsible for the compliance function across Biotherapeutics Analytical Research & Development (BTx ARD). The role sets compliance strategy and provides direction for quality system governance, inspection readiness, risk management, and continuous improvement, enabling compliant scientific and operational execution. As a trusted advisor to senior business, quality, and operational leaders, the role translates regulatory expectations, quality requirements, and business priorities into sustainable practices and organizational behaviors.

The position builds and develops a high-performing compliance team, strengthens quality culture, drives proactive risk management, and helps maintain continuous compliance and inspection readiness. Through strategic leadership and business partnership, the role protects ARD’s license to operate while enabling scientific innovation and business performance. The position is on premise and may involve occasional travel to other Pfizer sites. Rare overtime, off-shift, or holiday coverage may be required.

Requirements

• BS degree in Biology, Chemistry, or a related field and 6 or more years of experience in a GMP laboratory or similar field; alternatively, an MS degree and 5 or more years of experience, or a PhD and 1 or more years of experience.
• Demonstrated experience leading compliance, quality, regulatory, operational excellence, or related functions in a regulated environment.
• Experience leading and developing teams with accountability for talent, performance, and organizational outcomes.
• Experience working in GxP-regulated environments and quality management systems.
• Experience leading cross-functional initiatives and influencing decisions across multiple organizational levels.
• Experience supporting audits, inspections, regulatory interactions, or compliance programs.
• Strong communication, facilitation, stakeholder engagement, and change leadership capabilities.
• Ability to manage complexity, balance competing priorities, and deliver results through others.
• Permanent work authorization in the United States; U.S. work visa sponsorship is not available.

Nice To Haves

• Experience supporting research, development, laboratory, quality, manufacturing, or technical organizations.
• Experience leading enterprise compliance, quality transformation, governance, or continuous improvement initiatives.
• Experience facilitating executive governance reviews, Quality Management Reviews, and risk-management forums.
• Experience implementing or sustaining complex quality system processes.
• Experience supporting digital quality transformations, eQMS implementations, or AI-enabled compliance solutions.
• Experience partnering with Quality Assurance and regulatory-facing organizations.
• Demonstrated success leading organizational change and capability-building efforts.
• Self-motivated and effective in a team-based environment.
• Effective oral and written communication skills.
• Familiarity with 21 CFR Parts 210 and 211, ICH, and compendia guidelines (USP, EP, JP) in the framework of QC biological testing.

Responsibilities

• Lead the ARD Compliance function, defining strategy, priorities, and resource allocation to sustain compliance, inspection readiness, and quality system effectiveness.
• Advise and partner with ARD leadership, providing risk-based guidance, compliance expertise, and actionable recommendations.
• Build and develop a high-performing team through coaching, talent development, succession planning, performance management, and an inclusive culture of accountability and continuous improvement.
• Govern quality system processes, including CAPA, investigations, non-conformance management, change management, training compliance, procedural governance, Quality Action Plans, and quality risk management.
• Lead audit and inspection readiness, including preparation, execution support, response coordination, remediation oversight, and sustainable resolution of observations and commitments.
• Lead Quality Management Reviews, compliance councils, governance forums, and management reviews to communicate performance, emerging risks, commitments, and priorities.
• Monitor compliance metrics, trends, and quality system health to identify systemic risks and drive proactive interventions.
• Partner across scientific, laboratory, quality, operational, and digital organizations to apply regulatory expectations and quality requirements to sustainable business practices.
• Drive continuous improvement, standardization, simplification, and adoption of digital and AI-enabled capabilities.
• Strengthen ARD’s quality culture through training, communication, consultation, and leadership engagement.

Benefits

• 401(k) plan with Pfizer matching contributions and an additional Pfizer Retirement Savings Contribution
• Paid vacation, holidays, and personal days
• Paid caregiver/parental and medical leave
• Medical, prescription drug, dental, and vision coverage
• Eligibility for Pfizer’s Global Performance Plan, with a bonus target of 15% of base salary
• Eligibility to participate in a share-based long-term incentive program
• Relocation assistance may be available based on business needs and/or eligibility

What This Job Offers

• Job Type: Full-time
• Career Level: Senior