ESOQ Quality Transformation Lead

Pfizer • Collegeville, PA

8d • Hybrid

About The Position

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 The Quality Transformation Lead executes strategic and operational initiatives that reinforce sustainable compliance, continuous improvement, and audit readiness throughout the External Supply Operations Quality (ESOQ) organization. This role implements global Quality Systems optimization, applies proactive compliance measures, and integrates innovative technologies and methodologies to elevate quality standards and operational excellence.

Requirements

• Bachelor’s degree (BA/BS) in Science, Engineering, Pharmacy, or a related technical discipline.
• Minimum 10 years’ experience in pharmaceutical or medical device quality assurance roles, or 15 years’ experience in the industry.
• Deep expertise in GMP regulations, audit and inspection management, and leading quality systems.
• Experience with external suppliers/contractors and complex quality/compliance activities.
• Advanced proficiency in digital quality management systems and enterprise platforms (e.g., SAP, eQMS, Trackwise, Vault, Documentum).
• Demonstrated experience in continuous improvement methodologies (DMAIC, Six Sigma, Lean Belt trained preferred).
• Strong technical writing, verbal, and presentation skills.
• Proven leadership and facilitation skills, with the ability to influence and collaborate across all levels of the organization.
• Self-motivator with strong organizing, planning, and prioritization skills.
• Knowledge of US, European, and global cGMPs, compliance issues, inspectional trends, and industry quality assurance practices.
• 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.

Nice To Haves

• Experience in aseptic manufacturing and other pharmaceutical manufacturing activities (API, DP, Biotech, Oral Solid Dosage, Packaging, Development) and GDP requirements.
• Knowledge of main regulatory directives and guidelines (dossier structure, variation guideline).
• Knowledge of IMEx and OPEX.
• Method 1 certified and Method 2 or Lean Belt trained.

Responsibilities

• Executing ESOQ quality processes by conducting and documenting internal and self-inspections (SIA), systematically preparing audit materials, coordinating logistics for audit and inspection readiness, verifying data integrity, and tracking quality performance metrics to ensure all requirements are met.
• Applying lean and adaptive process improvements through the implementation of standardized best practices that address regulatory and internal requirements and using Gemba to identify process gaps and drive operational improvements.
• Managing the annual global site internal audit plan and self-inspection program by scheduling activities, preparing necessary documentation, facilitating audit execution, collecting evidence, supporting auditors during on-site activities, and ensuring thorough follow-up on findings and corrective actions for both internal and external audits and inspections.
• Acting as the main point of contact during audits and inspections by providing requested documentation, responding to inquiries from regulatory agencies, customers, and internal stakeholders, and ensuring all compliance requirements are addressed efficiently.
• Supporting the Critical Event Rapid Response Process by immediately initiating response protocols for compliance events, coordinating containment and investigation actions, documenting activities, and facilitating post-event reviews for continuous improvement.
• Executing strategic and cross-functional projects by managing timelines, monitoring progress, proactively resolving obstacles, and ensuring the achievement of project milestones.
• Implementing benchmarking activities by gathering and analyzing compliance and quality system practices from industry peers and internal partners to maintain up-to-date standards and procedures.
• Supporting the integration of AI and digital technologies by updating standard operating procedures, validating compliance with regulatory standards, and continuously monitoring system performance for effectiveness and reliability.
• Providing hands-on support and guidance to ESOQ colleagues by facilitating training sessions, demonstrating compliance activities, and encouraging the adoption of GMP, Lean/Six Sigma, IMEx, and digital quality management system tools.
• Identifying capability gaps and implementing targeted development plans to upskill ESOQ colleagues in operational excellence and quality management practices.
• Completing additional tasks as assigned by ESOQ leadership to support the organization’s quality and compliance objectives.

Benefits

• 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
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees