Program Lead - Data Integrity & Audit Readiness

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, which is both science and risk-based, is designed to be flexible, innovative, and customer-oriented. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contribution is crucial and will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a meaningful difference in the lives of those we serve.

The Program Lead, Data Integrity & Audit Readiness is responsible for leading and coordinating site-wide and cross-functional activities related to data integrity governance, audit commitments, regulatory observations, and remediation effectiveness. This individual serves as a key quality and compliance partner, ensuring commitments made to regulatory agencies, customers, and internal auditors are effectively tracked, implemented, verified, and sustained.

The role provides strategic oversight and influence without direct people management responsibilities. The successful candidate will collaborate across Quality, Operations, Engineering, Validation, Regulatory, Supply Chain, and Technical Services to strengthen compliance programs, drive continuous improvement, and maintain a state of inspection readiness.

WHAT YOU WILL ACHIEVE

In this role, you will:

• Co-lead the site Data Integrity governance program and support implementation of global data integrity requirements.
• Monitor and assess data integrity risks across systems, processes, and records.
• Facilitate Data Integrity assessments, gap analyses, and remediation activities.
• Partner with functional areas to ensure adherence to ALCOA+ principles and regulatory expectations.
• Analyze data integrity trends and metrics to identify systemic risks and improvement opportunities.
• Support development and execution of data integrity training, awareness programs, and communications.
• Serve as the central coordinator for commitments resulting from regulatory inspections, customer audits, corporate audits, and internal assessments.
• Establish and maintain governance processes for tracking commitments through completion and effectiveness verification.
• Partner with commitment owners to develop realistic action plans, milestones, and deliverables.
• Monitor progress against commitments and escalate risks, delays, or resource constraints.
• Prepare and present commitment status updates to site leadership and global stakeholders.
• Ensure commitment documentation is inspection-ready and supports regulatory expectations.
• Support site inspection readiness programs and regulatory preparedness activities.
• Participate in inspection planning, response development, and post-inspection remediation efforts.
• Review audit observations and commitments for alignment with quality system requirements and regulatory expectations.
• Support development of responses to regulatory observations and compliance-related inquiries.
• Maintain visibility of emerging compliance risks and recommend mitigation strategies.
• Support continuous improvement initiatives related to compliance, quality systems, and data governance.
• Drive or contribute to complex projects and team milestones/deliverables, exercising independent judgment under limited supervision.
• Promote consistent application of root-cause analysis, human-error reduction tools, and investigation process improvements to meet changing business needs.
• Exercises own judgement leveraging knowledge and experience with minimal assistance from Management.
• Provides peer leadership to mentor and develop other colleagues.

• Upkeep and development of department SOPs, monitoring alignment with regulations and Pfizer Quality Standards.
• Support audit teams, manage vendor audit status, and communicate inspection trends to stakeholders, addressing any identified gaps.

HERE IS WHAT YOU NEED (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience. 
• Strong knowledge of cGMP regulations and quality systems.
• Experience supporting regulatory inspections and audit response activities.
• Experience managing CAPAs, remediation programs, and compliance initiatives.
• Demonstrated ability to lead complex cross-functional projects without direct authority.
• Strong communication, facilitation, and stakeholder management skills.
• Proven analytical and problem-solving capabilities.
• Experience with electronic quality and business systems such as eQMS, QTS, Sherlock, PDOC’s, LIMS, SAP, MS Word, and MS Excel.
• Demonstrated strength in analytical skills and meticulous attention to detail.
• Proficiency in taking decisive action based on quality and compliance metrics and trends.
• Capable of managing multiple complex projects with a strong sense of business acumen.
• Excellent interpersonal effectiveness, coupled with superior written and verbal communication skills.

BONUS POINTS IF YOU HAVE (Preferred Requirements)

• Exceptional organizational and project management skills.
• Experience in quality control and/or quality assurance within the pharmaceutical industry.
• Experience in aseptic processes and operational knowledge.
• Experience with data integrity governance programs.
• Experience with FDA, EMA, MHRA, and other global regulatory inspections.
• Knowledge of Quality Risk Management principles and methodologies.
• Certification in Quality, Compliance, Project Management, or Lean Six Sigma.
• Ability to adapt to changing priorities and manage multiple tasks simultaneously.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.

PHYSICAL/MENTAL REQUIREMENTS

Sitting, standing, walking, ability to perform mathematical calculations, ability to perform complex data analysis, and ability to work periodically on the manufacturing floor with heightened safety awareness. Aseptic gowning may be required when entering applicable manufacturing areas.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Onsite or flex schedule, as aligned with site/business requirements.
• Core business hours are generally 8:00 a.m.–5:00 p.m.; occasional evening, weekend, or holiday work may be required to support operations, investigations, or commitments.
• No routine travel expected; occasional travel may be required (0–10%).
• Position may require work on the manufacturing floor and adherence to applicable safe work practices and aseptic gowning requirements.

OTHER JOB DETAILS

Work Location Assignment: Hybrid

Last Date to Apply for Job: November 10, 2026

The annual base salary for this position ranges from $99,200.00 to $165,400.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 12.5% 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