Operations Compliance Lead

Use Your Power for Purpose

Every day everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture rooted in science and risk-based compliance is both flexible and innovative always putting the customer first. Whether your role involves development maintenance compliance or research analysis your contributions are vital and directly impact patients. Our dedication to quality and safety ensures that we consistently meet the highest standards making a real difference in the lives of those we serve. As the Director of Quality Assurance within the Global Supply division you will play a pivotal role in improving patients lives by ensuring the highest standards of quality and safety in our products. Your leadership and expertise will drive the growth of our Quality Assurance team fostering a culture of innovation and excellence that directly impacts the well-being of patients worldwide.

What You Will Achieve

In this role you will:

• This role will drive compliance and performance excellence across the teams sites. The role will provide technical expertise drive compliance initiatives inspection readiness as well as continuous improvement projects. The role will work closely with the QO Lead on BOH notifications BOH responses AQRTs etc. This position will work closely across the Operating Unit and will liaise with the QO Leads as well as other Compliance leads to drive vertical and horizontal integration.
• Conduct data analytics/review to enable proactive detection of quality and compliance signals and trends. Drive remediation plans based on the signals and trends.
• Lead successful and timely execution of quality and compliance improvement initiatives.
• Drive compliance excellence by ensuring GMP inspection readiness for Regulatory Authorities and site inspection readiness. Provide technical SME support and BOH response writing/review
• Work in coordination with the QO Leads and QPL to drive the site regulatory strategy for key products site digital strategy and continuous improvement initiatives.
• Provide technical inputs to evaluate investigations product and process issues including the ability to identify root cause and corrective and preventative actions and accountable to provide leadership to drive issues to timely resolution.
• Provide rapid and effective cross-site coordination of significant investigation activities associated with low bioburden/sterile products.
• Provide quality decision making along with the QO Lead.
• Review and approval of significant investigations AQRT summaries BPDR/FAR and other technical documents as required
• Prepare and facilitate Quality/OpU Quality Review meetings.

Here Is What You Need (Minimum Requirements)

• BA/BS with at least 8 years of QA related experience or MBA/MS with at least 7 years of experience or PhD/JD with at least 5 years of experience or MD/DVM with at least 4 years of experience
• Demonstrated knowledge of US European and global cGMPs compliance issues inspectional trends industry quality assurance practices and systems and personal management skills.
• Proven leadership skills and ability to work across functions with all levels of the organization where the incumbent may not have direct authority.
• Demonstrated skills in analyzing organizing and project management with a high sense of urgency.
• Demonstrated change agility to successfully manage a high degree of complexity and priorities.
• Proven technical knowledge and expertise in root cause analysis (RCA) and CAPA activities
• Demonstrated in-depth understanding of global regulations guidelines and evolving legislation
• Excellent organizational analytical strategic interpersonal written and oral communication skills
• Thorough understanding and application of cGMP principles relevant quality processes systems and Country Specific Standards
• Experience in developing and leading complex projects and mid-term plans
• Ability to make decisions in complex problems and identify innovative solutions
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers develop and coach others oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Bonus Points If You Have (Preferred Requirements)

• Masters degree coupled with significant pharmaceutical experience.
• 5 years of robust site Quality management experience
• Proficiency in engaging with FDA EU investigators and other regulatory bodies during audits
• Profound grasp of compliance and quality management including the necessary procedures and audit readiness requirements
• Extensive experience within regulated environments encompassing policies procedures and processes
• Strong leadership and team-building skills
• Ability to influence and partner with cross-functional leadership
• Excellent problem-solving and decision-making abilities
• Strong project management skills
• Ability to foster a culture of innovation and continuous improvement

Non-Standard Work Schedule Travel or Environment Requirements

Based on the nature of this role travel is required (up to 30%).

Work Location Assignment:Hybrid

Other Job Details

• Last Date to Apply: December 5 2025

The annual base salary for this position ranges from $156600.00 to $261000.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 20.0% 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 lifes 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 (). 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.

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

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care providers name address and the type of payments or other value received generally for public disclosure. Subject to further legal review and statutory or regulatory clarification which Pfizer intends to pursue reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse your name address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race color religion sex sexual orientation age gender identity or gender expression national origin disability or veteran status. Pfizer also complies with all applicable national state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.

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Quality Assurance and Control