Senior Manager, ARD Compliance

Use Your Power for Purpose

The ARD Compliance Lead is a strategic people leader responsible for leading the compliance function across Biotherapeutics Analytical Research & Development (BTx ARD). This role provides direction for compliance strategy, quality system governance, inspection readiness, risk management, and continuous improvement efforts that enable compliant scientific and operational execution.

As the leader of the ARD Compliance organization, the ARD Compliance Lead serves as a trusted advisor to senior business, quality, and operational leaders, ensuring regulatory expectations, quality requirements, and business priorities are effectively translated into sustainable practices and organizational behaviors.

The role is accountable for building and developing a high-performing team of compliance professionals, strengthening quality culture, driving proactive risk management, and ensuring the organization maintains a continuous state of compliance and inspection readiness. Through strategic leadership, business partnership, and organizational influence, this role helps protect ARD's license to operate while enabling scientific innovation and business performance.

What You Will Achieve

• Lead the ARD Compliance function, defining strategy, priorities, and resource allocation to ensure sustained compliance, inspection readiness, and quality system effectiveness.
• Serve as the primary compliance advisor and strategic business partner to ARD leadership, providing risk-based guidance, compliance expertise, and actionable recommendations to support informed decision making.
• Build and develop a high-performing team of compliance professionals through coaching, talent development, succession planning, performance management, and an inclusive culture of accountability and continuous improvement.
• Provide leadership and governance for 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 activities, including preparation, execution support, response coordination, remediation oversight, and sustainable resolution of observations and commitments.
• Lead Quality Management Reviews (QMRs), compliance councils, governance forums, and management reviews to provide visibility to compliance performance, emerging risks, key commitments, and organizational priorities.
• Monitor compliance metrics, trends, and quality system health to identify systemic risks, drive proactive interventions, and strengthen organizational performance.
• Partners across scientific, laboratory, quality, operational, and digital organizations to translate regulatory expectations and quality requirements into effective and sustainable business practices.
• Drive continuous improvement, standardization, simplification, and adoption of digital and AI-enabled capabilities that enhance compliance effectiveness, organizational capability, and business performance.
• Strengthening quality culture across ARD through training, communication, consultation, and leadership engagement, ensuring quality and compliance are embedded in day-to-day operations.

Here Is What You Need (Minimum Requirements)

• BS degree in Biology, Chemistry, or related field with 6+ years of experience in a GMP laboratory or similar field; MS degree with 5+ years, or PhD with 1+ years
• Demonstrated experience leading compliance, quality, regulatory, operational excellence, or related functions within a regulated environment.
• Experience leading and developing teams with accountability for talent, performance, and organizational outcomes.
• Experience working within 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.
• Demonstrated ability to manage complexity, balance competing priorities, and deliver results through others.

Bonus Points If You Have (Preferred Requirements)

• Experience supporting research, development, laboratories, 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.

OTHER ATTRIBUTES DESIRABLE:

• Self-motivated and highly effective in a team-based environment

• Effective oral and written communication skills

• A strong familiarity with 21 CFR Part 210 and 211, ICH and Compendia guidelines (USP, EP, JP) within the framework of QC biological testing is preferred.

PHYSICAL/MENTAL REQUIREMENTS

Position requires occasional light lifting and periods of standing, sitting or walking.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Some occasional travel to other Pfizer sites is possible. Overtime, off shift coverage, or holiday coverage, though rare, may be required.

Additional Information:

• Work Location Assignment: On Premise

• Last Day to Apply: November 4, 2026

The annual base salary for this position ranges from $116,000.00 to $193,400.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% 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. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview.

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Research and Development

About Us

A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.