Job Description

Use Your Power for Purpose

At Pfizer, everything we do every day is driven by an unwavering commitment to delivering high-quality, safe, and effective products to patients. Our adaptable, innovative, and customer-focused quality culture ensures that your contributions in development, maintenance, compliance, or analysis through research programs will directly benefit patients. Your leadership will help us continue to meet and exceed the requirements of Pfizer and regulatory authorities, ensuring the quality of our products and fostering a culture of continuous improvement and innovation.

What You Will Achieve

Reporting to the Site Quality Operations Lead, this position is responsible for leading the quality strategy for continuous manufacturing across a 24/7 operation.

The role leads a 100–130‑person quality organization, ensuring robust quality systems that enable aseptic manufacturing and uninterrupted supply through effective risk management.

This position is responsible for driving quality culture and compliance and across the drug product lifecycle from Batch Issuance, across the manufacturing/packaging operations, through lot disposition.

The position will advise Site Leadership of significant events, overseeing the site’s quality event escalation meetings, providing strategic oversight to the site’s programs for quality on the floor, environmental controls and QA product realization requirements.

The role provides oversight and coaching to leaders responsible for risk-based decision making supporting continuous manufacturing operations and provide strategic management and leadership of the sites Quality Operations functions encompassing the following operational business units: Vial Manufacturing, Carpuject/ Syringe Manufacturing, Visual Inspection, Packaging, Pharmaceutical support areas (Dispensing/Compounding, Component Preparation, and/or Equipment Preparation), Warehouse operations and Retain Sample Management.

Interactions include Operations, Process Engineering, Technical Services, Validation, Compliance, Regulatory Affairs, FDA and other Regulatory Authorities, Network functions, and Supplier relations.

In this role, you will:

• Lead and develop a large, diverse quality organization, coaching leaders to enable effective risk-based decision making, strong quality culture, and consistent execution across all manufacturing and support functions.
• Responsible for individuals making real time risk-based decision making on the operations floor. Role provides coaching and strategic leadership to the quality triage and elevation process. Role manages quality on the floor teams inclusive of aseptic coaching and aseptic environmental monitoring.
• This role is responsible for management and direct oversight of the sites controlled environment monitoring, encompassing @250K samples annually.
• This role is responsible for the sites Batch Issuance, Batch Release/Disposition, and Quality Hold program.
• This role will provide oversight and leadership to individuals that analyze, develop, and improve quality systems and associated business processes, to achieve compliance with local, corporate, and global regulatory requirements and to drive continuous improvement.
• Serve as site approval authority for critical GMP documents ensuring regulatory compliance, data integrity, and effective quality risk management.
• Provide support for site audits and inspection, ensuring effective response development, commitment management, and sustained compliance.
• Manage Resources to meet organizational goals: Manage diverse team of Colleagues (performance reviews, development discussions, build teams, foster colleague engagement, deliver results, manage through others, etc.) Understand site financial systems and maintain departmental budget. Understand Site Safety objectives and maintain safe working environment
  

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
• Prior experience working in an Aseptic cGMP environment, with a strong working knowledge of a variety of pharmaceutical quality systems and processes.
• 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):

• Seven plus years’ experience in quality assurance within the pharmaceutical, regulatory and /or biotechnology industry.
• Five plus years of experience in a management or leadership role in Quality Assurance and/or Compliance leading a team of at least 30 individuals.
• Demonstrated proficiency in organizational and project management skills and must be able to balance multiple priorities
• A superior knowledge of GMPs and their application in quality assurance is required. Experience in direct interface with regulatory agencies and regulatory site inspections is essential.
• Excellent written and verbal communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups including senior leadership and regulatory agencies.
• Strong analytical and problem-solving abilities.

• Experience with six sigma methodology preferred

• Experience with SAP or other inventory control systems associated with product hold process is preferred.

PHYSICAL/MENTAL REQUIREMENTS

• Job duties involve occasional lifting (less than 35 lbs), reaching, and sitting while working at computer terminal.

• Ability to prioritize in a dynamic operation, ability to perform complex data analysis.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• This position requires some weekend and routine off shift as business needs dictate.

• Successful candidate will be required to complete various levels of gowning certification to enter and support the manufacturing areas

Work Location Assignment: On Premise

Last date to apply: April 10, 2027

The annual base salary for this position ranges from $176,600.00 to $294,300.00. 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 | (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.

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.

Pfizer endeavors to makewww.pfizer.com/careersaccessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please emaildisabilityrecruitment@pfizer.com This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.

Quality Assurance and Control