ESOQ Quality Transformation Lead

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.
 
The ESOQ Quality Transformation Lead is a senior execution leader responsible for driving complex transformation portfolios that strengthen inspection readiness, compliance, operational excellence, and digital/AI innovation across the External Supply Operations Quality (ESOQ) organization. The role translates strategy into execution through structured program leadership, cross-functional collaboration, and sustainable implementation of new ways of working across a global external supply network.
 
What You Will Achieve
 

• Leading assigned ESOQ transformation programs and workstreams that advance sustainable compliance, inspection readiness, operational excellence, and organizational effectiveness.

• Leading inspection readiness activities for assigned scope, including support for external inspections involving CMOs / suppliers and internal inspections, self-inspections, and RQA audit readiness, ensuring robust preparation, coordination, execution support, and follow-up.

• Leading and/or coordinating elements of the annual audit and self-inspection planning cycle for assigned areas, including schedule development, readiness tracking, issue remediation, lessons learned, and post-audit / post-inspection follow-up.

• Driving the ESOQ Gemba process for assigned scope, ensuring observations, escalations, actions, and learnings are translated into sustainable improvements.

• Driving the Quality Revolution agenda through implementation of new ways of working, capability building, stakeholder engagement, and a proactive quality culture.

• Driving cross-network learning from inspections, audits, and CAPAs, ensuring observations at one CMO or supplier are assessed for broader applicability and translated into preventive actions across the network to strengthen inspection readiness.

• Developing, monitoring, and communicating metrics / KPI reporting that provide visibility to compliance performance, inspection readiness, audit outcomes, remediation progress, and transformation effectiveness.

• Driving CAPA closure and effectiveness verification across assigned scope, ensuring clear ownership and accountability across ESOQ, Site QA, and CMO QA

• Applying Quality Risk Management principles to identify, assess, prioritize, and mitigate risks associated with compliance, quality systems, business process changes, and transformation initiatives.

• Leading continuous improvement initiatives that simplify and strengthen quality processes, governance routines, and inspection readiness practices using lean, risk-based, and data-driven approaches.

• Leading or supporting the design and implementation of innovative AI and digital transformation solutions in quality processes, ensuring alignment with regulatory expectations, data integrity principles, and business value objectives.

• Partnering with ESOQ leadership and cross-functional stakeholders to assess readiness, manage impacts, and drive sustainable adoption of transformation initiatives.

• Develop and execute integrated change, communication, and training strategies to support adoption of new ways of working, ensuring alignment across global stakeholders and reinforcement of desired behaviors and mindset.

• Leading governance routines, milestone tracking, issue and risk management, and execution reporting for assigned programs or project portfolios.

• Supporting audit and inspection response activities, including readiness reviews, management reporting, CAPA follow-up, trend analysis, and continuous learning.

• Benchmarking internally and externally to identify best practices and integrate relevant learnings into ESOQ processes, systems, and ways of working.

• Providing leadership through influence, collaboration, and subject matter expertise across ESOQ and partner functions.

• Leading end-to-end change management for transformation initiatives, including impact assessments, stakeholder analysis, change strategy development, communication planning, capability building, and reinforcement mechanisms to ensure sustainable adoption of new processes, systems, and behaviors.
   
  Focus Areas

• Drive AI-enabled quality transformation initiatives across ESOQ.

• Identify, prioritize, and implement high-value AI use cases supporting compliance, inspection readiness, knowledge management, efficiency, and decision-making.

• Ensure AI-enabled solutions are introduced in a compliant, responsible, risk-based, and practical manner.

• Lead inspection readiness, internal and external audit support, self-inspection readiness, remediation tracking, and compliance improvement programs.

• Drive readiness for regulatory, customer, partner, supplier, and internal audit activities within assigned scope.

• Lead program governance, business process optimization, roadmap delivery, milestone management, portfolio reporting, and transformation execution discipline.

• Strengthen operating rhythms, governance forums, KPI transparency, and portfolio visibility across ESOQ transformation initiatives.
   
  This is an opportunity to take a visible leadership role in shaping the future of quality across a complex, global external supply network. You will operate at the intersection of inspection readiness, transformation, and innovation, driving enterprise-wide impact.
   
  In this role, you will influence how ESOQ strengthens compliance while enabling agility, digital innovation, and continuous improvement - working with senior stakeholders and diverse global partners to build scalable, sustainable solutions.
  
  Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 8 years of experience; OR a master's degree with at least 7 years of experience; OR a PhD with 5+ years of experience.

• Significant experience in the pharmaceutical or life sciences industry, including substantial exposure to quality, compliance, inspection readiness, and/or operational excellence within regulated environments.

• Strong working knowledge of GMP/GDP requirements, global regulatory expectations, and inspection practices, including experience supporting or preparing for regulatory inspections, audits, and quality system oversight.

• Demonstrated experience leading complex, cross-functional transformation initiatives with measurable impact in regulated environments, including the ability to translate strategy into execution and sustainable outcomes.

• Experience in inspection readiness and audit lifecycle activities, including preparation, coordination, execution support, issue identification, and follow-up within internal and/or external audit contexts.

• Proven ability to apply Quality Risk Management principles and structured problem-solving approaches to identify, prioritize, and mitigate quality and compliance risks.

• Experience developing and utilizing metrics / KPI reporting and governance frameworks to monitor performance, drive accountability, and enable data-driven decision-making.

• Strong program and project management capabilities, including experience managing multiple initiatives, prioritizing workload, and driving execution through structured governance routines.

• Demonstrated ability to influence, collaborate, and drive alignment across global, cross-functional, and matrixed organizations, including engagement with senior stakeholders.

• Strong communication, facilitation, and stakeholder engagement skills, with the ability to effectively convey complex topics and drive adoption of new ways of working.

• Demonstrated experience leading change management for complex transformation initiatives, including stakeholder engagement, organizational readiness assessment, communication strategy, capability development, and sustainment in regulated environments.
   
  Bonus Points If You Have (Preferred Requirements)

• Experience working within complex external supply networks, including oversight of CMOs, suppliers, and global third-party partners, with a strong understanding of associated quality and compliance risks.

• Proven experience in inspection readiness and audit management, including preparation, execution support, remediation management, CAPA follow-up, and continuous readiness governance for regulatory, customer, partner, and internal (RQA/self-inspections) audits.

• Experience applying continuous improvement methodologies (e.g., Lean, Six Sigma, DMAIC, IMEx, OPEX) to drive measurable process simplification, efficiency gains, and sustainablecompliance improvements.

• Experience driving business transformation, PMO, or governance models, including portfolio management, milestone tracking, performance reporting, and cross-functional execution discipline.

• Experience in digital and AI-enabled transformation within quality systems, including identification and implementation of scalable, compliant solutions that enhance decision-making, efficiency, and inspection readiness.

• Demonstrated ability to influence senior stakeholders and operate effectively across diverse, global, and matrixed organizations.

• Demonstrated breadth of leadership capability, including the ability to drive outcomes through influence, lead change, and build alignment across quality, supply chain, regulatory, and business functions.

• Experience supporting or leading regulatory inspections with direct involvement in Front Office / Back Office operations, including coordination of SMEs, document management and rapid retrieval, management of inspection war rooms, facilitation of information flow between front room and back-room teams, and real-time issue resolution.

• Demonstrated ability to ensure inspection control, maintain data integrity, and support effective, compliant communication strategies with inspectors during health authority inspections (e.g., FDA, EMA) is highly preferred.

• Experience working with digital quality systems and enterprise platforms (e.g., eQMS, SAP, TrackWise, Vault, Documentum, or comparable systems).

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Up to 20% travel

• Non standard work hours act.
  
  Work Location Assignment: Hybrid

The annual base salary for this position ranges from $162,900.00 to $271,500.00. 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. This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview.

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