Director, Computer System Quality Team Lead
Core
Strategic leadership for Computer System Assurance and quality oversight of GMP/GDP computer systems, AI, and federated solutions across Pfizer sites and Digital organizations.
Role type
Director, Computer System Quality
Builds
Enterprise Digital, artificial intelligence, and federated solutions that are controlled, compliant, and inspection-ready.
Domain
Life Sciences / Pharmaceutical Quality Assurance / Computerized System Validation
Required skills
Risk-based assurance, Computer System Validation (CSV), GMP/GDP compliance, Cross-functional leadership, Regulatory inspection readiness, Quality Risk Management, Strategic planning, Stakeholder influence, Continuous improvement, Audit and inspection management
Preferred skills
GAMP 5, ICH Q9, EU Annex 11, 21 CFR Part 11, AI/automation assurance, IMEx/Lean/Six Sigma, Data monitoring tools
Technologies
GAMP 5, ICH Q9, EU Annex 11, 21 CFR Part 11, AI, Automation, Cloud-based solutions, Federated Digital solutions, IMEx
Responsibilities
Define risk-based Computer System Assurance strategies; Serve as Quality authority for the Digital process framework; Provide authoritative quality decisions for complex system risk assessments; Establish quality oversight for validation of GMP/GDP enterprise Digital and AI solutions; Lead portfolio-level audit and inspection readiness; Represent quality matters during regulatory inspections; Monitor evolving regulatory expectations; Identify opportunities to simplify assurance via AI and automation; Provide strategic oversight for Computer System Assurance and EDES enhancement.
Seniority
Director, Strategic Leadership