Strategic Process Lead – Analytical Quality

Pfizer

. Own PharmSci Investigational Product Analytical Quality processes and ensure compliance with global procedures, regulatory requirements, and Pfizer expectations .

Posted 10/22/2026full-timeUnited StatesSenior💰 $124,400 - $207,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Analytical Quality processes, regulatory compliance, and continuous improvement within the pharmaceutical industry. Proficient in leading process governance, stakeholder engagement, and training development to enhance organizational capabilities.

Highest-signal resume keywords

Analytical R&D KnowledgeGMP/GDP RequirementsProcess Deployment LeadershipTraining Material DevelopmentStakeholder Influence

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality SystemsLaboratory InvestigationsNonconformance ManagementChange ManagementProcess DocumentationContinuous ImprovementRisk ManagementDigital System RequirementsRegulatory CompliancePerformance Metrics Monitoring

Soft Skills

Excellent CommunicationCollaboration SkillsProblem-Solving MindsetNegotiation SkillsConflict Resolution

Tools & Technologies

AI ToolsChat GPTMicrosoft Copilot

Industry Keywords

PharmaceuticalBiotechnologyQuality EnvironmentsMedical Device Combination Product RegulationsInspection Readiness

About the role

Key responsibilities & impact

Own PharmSci Investigational Product Analytical Quality processes and ensure compliance with global procedures, regulatory requirements, and Pfizer expectations
Define and continuously improve processes with SMEs and the Global Process Owner
Establish and maintain process documentation, including Global Work Instructions, Local Work Instructions, 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 KPIs
Identify and address risks, adverse trends, compliance gaps, and improvement opportunities
Escalate process risks and compliance concerns to appropriate global and PharmSci leadership
Lead implementation and deployment of Global Analytical Quality process enhancements and system changes
Manage local change management activities, impact assessments, change controls, implementation actions, and stakeholder engagement
Ensure deployment deliverables, documentation updates, training analyses, and readiness activities are completed on schedule
Develop and maintain Investigational Product-specific learning materials and resources
Identify colleagues requiring training and partner with training teams on assignment, completion, and qualification
Identify opportunities to simplify, standardize, and digitize process execution and documentation
Define digital system requirements with SMEs and represent PharmSci in digital enhancement and transformation initiatives
Lead or contribute to Continuous Improvement projects
Build partnerships with local SMEs, Quality colleagues, business partners, and global process stakeholders
Represent local business needs, regulatory commitments, and best practices to the Global Process Owner
Influence global process design and foster alignment across functions
Communicate process expectations, design decisions, and best practices
Act as trusted advisor for Investigational Product Analytical Quality processes
Maintain inspection readiness and serve as 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 and co-develop responses and remediation plans

Requirements

What you’ll need

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
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, and understanding of responsible AI practices, including risk management and ethical use
Strong knowledge of Nonconformance
Experience developing training materials, 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
Breadth of diverse leadership experiences and capabilities, including influencing and collaborating with peers, developing and coaching others, and overseeing and guiding colleagues
Candidates must be authorized to be employed in the U.S. by any employer
U.S. work visa sponsorship is not available now or in the future
Requires permanent work authorization in the United States

Benefits

Comp & perks

Global Performance Plan with a bonus target of 17.5% of base salary
Share based long term incentive program
401(k) plan with Pfizer Matching Contributions
Additional Pfizer Retirement Savings Contribution
Paid vacation, holiday and personal days
Paid caregiver/parental and medical leave
Medical, prescription drug, dental and vision coverage
Relocation assistance may be available based on business needs and/or eligibility