Director, Computer System Quality Team Lead

Pfizer

. Define and advance risk-based Computer System Assurance strategies and practices across PGS sites and Digital organizations .

Posted 10/22/2026full-timeCollegeville • Pennsylvania • United StatesSenior💰 $176,600 - $294,300 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Computer System Assurance, risk-based validation, and quality management within regulated environments. Proven ability to lead cross-functional initiatives, influence stakeholders, and ensure compliance during regulatory inspections.

Highest-signal resume keywords

Computer System AssuranceRisk-Based ValidationGMP/GDP ComplianceQuality Risk ManagementRegulatory Inspection Readiness

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Computerized-System QualityQuality Process MaintenanceContinuous ImprovementSystem MonitoringData AnalysisAutomationGAMP 5ICH Q9EU Annex 1121 CFR Part 11

Soft Skills

Strong Communication SkillsInfluencing Senior LeadersIndependent JudgmentCollaborationCoaching Others

Tools & Technologies

IMExLeanSix SigmaCloud-Based SolutionsFederated Digital Solutions

Certifications & Qualifications

Quality CertificationAuditing CertificationRisk-Management Certification

Industry Keywords

Regulated EnvironmentQuality AssuranceDigital SolutionsInspection SupportCross-Functional Initiatives

Tech Stack

Tools & technologies

Cloud

About the role

Key responsibilities & impact

Define and advance risk-based Computer System Assurance strategies and practices across PGS sites and Digital organizations
Serve as Quality authority for the Digital process framework
Provide quality decisions and recommendations for enterprise-system risk assessments, classifications and assurance approaches
Establish quality oversight for validation and ongoing management of GMP/GDP enterprise Digital, artificial intelligence and federated solutions
Provide strategic leadership for the Level 2 Computer System Assurance process, including governance, maintenance, adoption, continuous improvement, process-change management, metrics and inspection support
Lead portfolio-level audit and inspection readiness, identify systemic risks and recommend corrective or preventive actions
Provide subject-matter leadership for computerized-system investigations, compliance risks and escalations
Represent computerized-system quality matters during regulatory inspections, internal audits and senior governance forums
Monitor regulatory expectations and industry practices and translate implications into quality strategies, standards and controls
Advance Computer System Assurance through artificial intelligence, automation and other Digital capabilities
Define risk-based approaches for continuous system-health monitoring and periodic review
Provide strategic oversight for Computer System Assurance and EDES enhancement, adoption and value realization
Monitor Computer System Assurance network health and recommend improvements
Lead IMEx reporting, resource visibility, risk assessment and escalation
Partner with Business System Owners, Global Process Owners, Digital and artificial intelligence teams, portfolio management, Governance, Risk and Compliance, and other stakeholders
Provide strategic support to and deputize for the Computer System Assurance Global Process Owner as appropriate
Advise senior leaders on assurance, compliance risk, regulatory expectations and inspection readiness

Requirements

What you’ll need

Bachelor’s degree in a scientific, engineering, technology, data, quality or related discipline with at least eight years of relevant experience; or a master’s degree with at least seven years of relevant experience; or a doctoral degree with at least five years of relevant experience
Significant experience in computerized-system quality, Computer System Assurance or computerized-system validation within a GMP/GDP or similarly regulated environment
Demonstrated expertise in risk-based assurance, validation, quality-risk management and ongoing management of regulated computer systems
Experience providing subject-matter leadership for a significant quality process, including process maintenance, adoption, continuous improvement and inspection support
Demonstrated experience leading complex, cross-functional initiatives in a global, highly matrixed organization
Experience representing Quality during regulatory inspections, internal audits or inspection-readiness activities
Ability to exercise independent judgment and develop defensible recommendations for complex and ambiguous quality or compliance matters
Ability to influence senior leaders and align Quality, Digital, site and business stakeholders without direct authority
Strong written and verbal communication skills, including translating technical assurance matters into clear quality, risk and business implications
Advanced degree in a scientific, engineering, technology, data, regulatory or quality discipline preferred
Quality, auditing, risk-management, Digital or computerized-system assurance certification preferred
Experience with GAMP 5, ICH Q9, EU Annex 11, 21 CFR Part 11 and other relevant computerized-system requirements and guidance preferred
Experience with artificial intelligence, automation, cloud-based or federated Digital solutions preferred
Experience establishing system-monitoring, periodic-review or inspection-readiness practices at portfolio scale preferred
Experience applying IMEx, Lean, Six Sigma or comparable continuous-improvement methods preferred
Experience using data, monitoring tools or automation to improve assurance effectiveness and efficiency preferred
Ability to influence and collaborate with peers, develop and coach others, and oversee and guide colleagues’ work
Ability to evaluate multiple complex and concurrent inputs, exercise sound judgment and develop actionable recommendations
Ability to manage competing priorities in a complex, matrixed and globally distributed environment
Periodic participation in meetings outside standard working hours may be required
Occasional business travel may be required
Must be authorized to be employed in the U.S. by any employer
Must have permanent work authorization in the United States
U.S. work visa sponsorship is not available now or in the future

Benefits

Comp & perks

Global Performance Plan with a bonus target of 20.0% of base salary
Share based long term incentive program
401(k) plan with Pfizer Matching Contributions
Additional Pfizer Retirement Savings Contribution
Paid vacation
Paid 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