Sr Mgr., Quality Regulatory Reporting & Investigations

Use Your Power for Purpose

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our innovative, flexible, and customer-oriented science and risk-based compliant quality culture drives everything we do. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution is vital and directly impacts patients.

What You Will Achieve

The Sr. Manager, Quality Regulatory Reporting & Investigations is entrusted with the leadership and direction of comprehensive activities related to complaint investigations, investigation approvals, market actions and regulatory reporting. This position is responsible for ensuring that all complaint and manufacturing investigations are conducted with the utmost integrity, timeliness, and in strict accordance with internal policies as well as applicable regulatory requirements. The Senior Manager is expected to foster a culture of continuous improvement by critically analyzing systemic trends, identifying root causes, and formulating corrective and preventive actions.

Leads a team to ensure that all external surveillance quality systems meet defined quality standards and objectives.  Fosters teamwork and colleague development, as well as change management, within the department and the function

In this role, you will:

• Oversee all aspects of complaint investigations, ensuring adherence to organizational procedures and regulatory standards.

• Primary site responsibility for management of the following surveillance programs: Complaints, BOH Reporting and associated SQRT’s, enhanced SQRT’s and AQRT’s. 

• Oversee the review and approval of investigation reports, corrective actions, and preventive measures, verifying their completeness and regulatory conformity.

• Develop, prepare, and submit regulatory reports in compliance with local, national, and international requirements.

• Establish and maintain robust documentation for regulatory reporting submissions, audits, and inspections.

• Engage with regulatory bodies and stakeholders to ensure transparent communication and prompt reporting of adverse events and product complaints.

• Monitor and analyze complaint data, identify systemic issues, and implement effective solutions.

• Collaborate cross-functionally with teams including manufacturing, quality, and regulatory affairs to enhance processes and drive compliance excellence.

• Provide training, mentorship, and guidance to personnel on investigative procedures and regulatory reporting requirements.

• Acts as technical/functional expert providing leadership and direction to direct reports associated with Customer Complaints as well as other teams across own and related disciplines

• Identifies existing process / product improvements and develops innovative, advanced new concepts that improve the work processes / products across Quality and related disciplines

• Manages and leads people, technological and financial resources at the Sub Business Unit/Sub Operating Unit level for multiple projects and on-going work activities of moderate complexity within multiple sub functions; May lead by influence rather than direct authority
• Solves complex problems across own and related disciplines; Decisions impact Quality Unit midterm objectives while long-term decisions are reviewed by senior management

• Manage teams that execute direction in support of Sub Business Unit/Sub Operating Unit leadership objectives

• Provides input to senior management decisions that have impact on business direction within Sub Business Unit/Sub Operating Unit

• Provides significant peer leadership to colleagues throughout the site to develop responses to regulatory requests

• Oversee the accuracy of Metrics and Tracking information for FARs and AQRTs (Area Quality Review Teams)

• Oversees communication between site and global subject matter experts in driving on-time completion of initial, follow-up and final regulatory notifications  

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 6+ years of
  experience; OR a master's degree with at least 5+ years of experience; OR
  a PhD with 1+ years of experience
• Supervisory/management experience
• Excellent written and verbal communication skills with the ability to interact with senior leadership and regulatory agencies
• 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)

• 2+ years of regulatory experience
• 2+ years of Quality experience in manufacturing environment
• Project management experience
• Customer-facing leadership with audits/complaints
• Experience with metrics and governance
• Strong understanding of escalation pathways and supply continuity

PHYSICAL/MENTAL REQUIREMENTS

Sitting, standing, walking, ability to perform/verify mathematical calculations, and ability to perform complex data analysis

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• On site core hours 8-5, occasional evening, weekend or holiday work required
• No routine travel

Other Job Information:

• Relocation support available
• Work Location Assignment: On Premise
• Last Date to Apply: July 30, 2026

The annual base salary for this position ranges from $139,100.00 to $231,900.00. In addition, this position is eligible for 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. 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.

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.

Quality Assurance and Control