ESOQ Excellence and Continuous Improvement Team Lead

About the position Use Your Power for Purpose Everything we do every day is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based quality culture is both flexible and innovative, always putting the customer first. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your role is crucial. Your contributions directly impact patients, ensuring the highest standards of quality and safety. Join us in our mission to make a difference in patients' lives through dedication and excellence in every aspect of our work. What You Will Achieve The ESOQ Excellence and Continuous Improvement Team Lead provides strategic and operational leadership for sustainable compliance, continuous improvement, and audit execution and readiness across the External Supply Operations Quality organization. This role is accountable for the governance and optimization of related global Quality Systems, ensuring alignment with Pfizer and regulatory requirements, and fostering a culture of proactive compliance and operational excellence.

Responsibilities

• Providing leadership and coaching to a global team, fostering empowerment, capability building, GMP compliance and high performance
• Works with the ESOQ LT to assess high priority matters that require interventions and deliver sustainable interventions.
• Ensure the global team executes: The development, deployment, and execution of ESOQ continuous improvement of ESOQ Quality processes including Internal and Self-Inspections, Audit and Inspection Readiness, Data Integrity, Leader Standard Work and Quality Performance Metrics.
• Driving sustainable compliance initiatives and embedding best practices for regulatory and internal requirements, with a focus on lean and adaptive processes.
• The ESOQ Gemba process, ensuring effective compliance and remediation, and promoting a culture of transparency, engagement, and continuous improvement.
• The annual global site internal audit plan and self-inspection program, ensuring robust preparation, execution, and follow-up for both internal and external audits and inspections.
• Acting as a key liaison with regulatory agencies, customer/partner and internal stakeholders during audits and inspections and leading the investigation and resolution of significant compliance events.
• Collaborating within ESOQ and global partners to align on compliance strategies, share best practices and quality events, and drive harmonization of processes.
• Ensuring effective communication and escalation of critical compliance issues to senior leadership and relevant stakeholders.
• Benchmarking with industry peers and internal partners to ensure ESOQ maintains best-in-class compliance and quality system practices.
• Lead the integration of AI technologies to complement standard operating procedures by ensuring compliance with regulatory standards, and continuous monitoring of AI performance.
• Foster a culture of responsible AI use through transparent communication, stakeholder engagement, and ongoing training, enabling teams to leverage AI for enhanced efficiency, quality, and innovation.
• Lead the Critical Event Rapid Response Process and Team, ensuring immediate and coordinated action for all critical compliance events. Facilitate rapid SME involvement, maintain inspection readiness, oversee real-time documentation and communication, and drive post-event reviews to continuously improve response effectiveness and compliance outcomes.

Requirements

• Bachelor’s degree (BA/BS) in Science, Engineering, or a closely related field is required.
• At least 15 years of progressive experience in pharmaceutical quality roles, with deep expertise in GMP regulations, audit and inspection management, and leading quality systems.
• Proven track record in driving sustainable compliance, continuous improvement initiatives, and successfully leading self-inspection and Gemba processes.
• Comprehensive understanding of US, European, and global cGMP standards, current compliance trends, and best practices in quality assurance.
• Demonstrated ability to lead and influence organizational change, including managing virtual and globally distributed teams.
• Exceptional communication, facilitation, and stakeholder influencing skills, with an emphasis on transparency and engagement.
• Advanced proficiency in digital quality management systems and enterprise platforms such as SAP, eQMS, and Trackwise.
• Strong analytical abilities, project management expertise, and critical thinking skills to support continuous improvement and compliance excellence.
• Demonstrated breadth of diverse leadership experiences and capabilities, including the ability to influence and collaborate with peers, develop and coach others, and oversee and guide the work of 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.
• Prior experience leading a team.

Benefits

• In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 22.5% 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.

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