The posting
Pharmaceutical Sciences (PharmSci) Analytical Quality Strategic Process Lead
Use your power for purpose
At Pfizer, our ability to deliver breakthroughs to patients depends on the strength, reliability, and continuous improvement of our global business processes and Quality Management Systems. As a Strategic Process Lead within Pharmaceutical Sciences (PharmSci), you will provide strategic leadership and governance for critical end-to-end processes, ensuring they remain compliant, efficient, and fit for purpose. Through effective governance, risk management, capability building, and data-driven decision-making, you will help ensure Pfizer continues to deliver medicines safely, reliably, and efficiently to patients worldwide.
Role Summary
As part of the Non-Conformance Strategic Compliance Team within Pharmaceutical Sciences Operations Quality (PSOQ), the Analytical Quality Strategic Process Lead serves as the Pharmaceutical Sciences (PharmSci) Local Process Owner (LPO) for several Analytical Quality processes which could include Laboratory Investigation Report Out Of Specification (LIR OOS), Laboratory Controls, Documentation, Stability, Analytical Method Development, Test Method Verification, Validation and Transfer. The role is responsible for ensuring the effective design, deployment, governance, compliance, performance monitoring, and continuous improvement of the Investigational Product (IP) Analytical Quality processes, partnering closely with SMEs and serving as the primary liaison between PharmSci and the Global Process Owner (GPO) in support of the Quality Management System (QMS) strategic compliance model.
The successful candidate will drive process excellence, support regulatory compliance and inspection readiness, influence global process strategy, and champion simplification and adoption across the organization.
What You Will Achieve
Process Ownership & Governance
- Own the PharmSci Investigational Product Analytical Quality processes and ensure ongoing compliance with global procedures, regulatory requirements, and Pfizer expectations.
- Define and continuously improve the PharmSci Investigational Product Analytical Quality processes in collaboration with SMEs and the Global Process Owner.
- Establish and maintain the appropriate process documentation structure, including Global Work Instructions (GWIs), Local Work Instructions (LWIs), and supporting materials.
- Lead local process governance activities and communities of practice.
- Represent PharmSci in Global Process Centric Teams.
- Monitor process health, performance metrics, compliance trends, and key performance indicators (KPIs).
- Identify and address emerging risks, adverse trends, compliance gaps, and improvement opportunities.
- Escalate process risks, compliance concerns, and significant issues to the Global Process Owner, PharmSci Revolution Site Lead and appropriate PharmSci leadership.
- May serve as backup LPO for other Quality Management System (QMS) processes.
Global Process Deployment & Change Management
- Lead the implementation and deployment of Global Analytical Quality process enhancements and system changes within PharmSci.
- Manage local change management activities, including impact assessments, local change controls, implementation actions, and stakeholder engagement.
- Ensure all deployment deliverables, documentation updates, training needs analyses, and readiness activities are completed on schedule.
Training Development & Tracking
- Develop and maintain IP specific learning materials and supporting resources.
- Contribute to the development of Global learning materials.
- Identify colleagues requiring training and partner with training teams to ensure appropriate assignment, completion, and qualification.
Digital Enablement & Continuous Improvement
- Identify opportunities to simplify, standardize, and digitize process execution and documentation.
- Define digital system requirements in collaboration with SMEs to enhance user experience, compliance, and process effectiveness.
- Represent PharmSci in digital enhancement discussions and process transformation initiatives.
- Lead or contribute to Continuous Improvement (CI) projects that strengthen the global process and user experience.
- Champion process simplification, standardization, and adoption across the organization.
Stakeholder Engagement & Collaboration
- Build strong partnerships with local SMEs, Quality colleagues, business partners, and global process stakeholders.
- Gather and represent local business needs, regulatory commitments, and best practices in discussions with the Global ProcessOwner.
- Influence global process design by advocating for PharmSci requirements where appropriate.
- Foster alignment across functions and ensure effective communication of process changes and expectations.
- Support knowledge sharing and build organizational capability by communicating process expectations, design decisions, and best practices.
- Act as a trusted advisor for the Investigational Product Analytical Quality processes across PharmSci.
Audit & Inspection Support
- Partner with stakeholders to maintain inspection readiness and promote a culture of quality and continuous improvement.
- Serve as the primary Process SME during internal audits, and regulatory inspections.
- Explain process design, governance, and compliance rationale to auditors and inspectors.
- Share audit and inspection learnings with the Global Process Owner, fellow LPOs, SMEs and Inspection Readiness teams to support continuous improvement.
- Co-develop responses and remediation plans for process-specific audit and inspection observations.
Here is what you need (Minimum Requirements):
- Bachelor's degree with at least 6 years of relevant experience; OR Master's degree with at least 5 years of relevant experience; OR PhD/JD with at least 1 year of relevant experience. Strong knowledge of Analytical R&D, laboratory investigations/OOS management, quality systems, and GMP/GDP requirements.
- Strong knowledge of Analytical R&D, laboratory investigations/OOS management, quality systems, and GMP/GDP requirements.
- Demonstrated experience leading process deployments, governance activities, or quality system improvements.
- Ability to influence stakeholders across all functions and levels of the organization.
- Strong analytical, problem-solving, and continuous improvement mindset.
- Experience working in regulated pharmaceutical, biotechnology, or quality environments.
- Excellent communication, collaboration, and change management skills.
- Proactive approach to problem-solving
- Experience using common AI tools, including generative technologies such as Chat GPT 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
Bonus Points If You Have (Preferred Requirements)
- Strong Knowledge of Nonconformance
- Experience developing training materials or delivering training or driving organizational capability building.
- Skilled in negotiation, and conflict resolution.
- Experience with external Laboratory LIR and Third Party Deviations.
- Knowledge of Medical Device Combination Product (MDCP) regulations and guidance.
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.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Some work outside of standard working hours may be required to support the global nature of the role.
OTHER JOB DETAILS
Last Date to Apply for Job: 10/29/26
Work Location Assignment: Hybrid
The annual base salary for this position ranges from $124,400.00 to $207,400.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% 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.
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.
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.
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Quality Assurance and Control
