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 a Operations Compliance Lead within IMOQ, you will drive compliance and performance excellence across the team's 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 Operations Quality Lead on BOH notifications, BOH responses, AQRT's, etc. This position will work closely across the Operating Unit and will liaise with the SQOLs as well as other Operations Compliance leads to drive vertical and horizontal integration.

What You Will Achieve

In this role, you will:

• 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 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 analytical skills capable of evaluating complex data to identify trends and signals.

• Excellent interpersonal and leadership skills, including a demonstrated ability to positively influence and coach others, participate in teams at all levels of management and achieve results through others.

• Leadership and management of projects that require collaborative approaches, strong analytical skills, and a solid ability to understand business issues and processes.

• Must be fluent in English.

Bonus Points If You Have (Preferred Requirements)

• Ability to foster a culture of innovation and continuous improvement.

• 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.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Up to 30% travel.

Other Job Details:

• Last day to Apply: December 9th, 2025

• Work Location Assignment: Hybrid

The annual base salary for this position ranges from $156,600.00 to $261, In addition, this position is eligible for participation in Pfizer's 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 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 | ). 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 provider's 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

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