Associate Director leading innovation initiatives for LGBTQ+ health at Penn. Overseeing project execution and sustainability strategies to improve health outcomes.
About the role
- Asset Quality Lead responsible for GCP Quality and oversight of clinical trial programs at Pfizer. Collaborates with cross-functional teams to drive quality risk management and inspection readiness activities.
Responsibilities
- Drive GCP Quality by maintaining quality oversight for assigned clinical trial programs/protocols
- Oversee study-level quality risk management activities including Study Risk Profile development
- Provide Study Team Inspection Readiness guidance and support
- Develop inspection readiness tools and processes
- Communicate key quality information across study teams
- Collaborate with cross functional study team and drive quality risk management activities
- Lead asset level/study level quality risk planning activities
Requirements
- A scientific or technical degree is preferred
- BS: 10+ years or equivalent
- MS/MBA: 7+ years or equivalent
- Strong, advanced knowledge, experience and expertise in ICH GCP, clinical trial development, and operational GCP quality management disciplines
- Familiarity with relevant key therapeutic area(s)
- Oncology experience strongly preferred
- Advanced clinical trials experience, especially operational processes and/or systems
- Strong interpersonal skills, ability to influence, engage leaders and establish and maintain excellent working relationships
- Experience of working on global initiatives or project teams
- Extensive knowledge of regulations to assess GCP situations and coordinate resolution activities
- Excellent knowledge of Pfizer SOPs and quality management processes
- Extensive Quality related experience including working knowledge in areas of: Quality and compliance management, QC Root Cause Analysis, Metrics development and utilization, Audit and Inspection conduct, CAPA development and response process, Inspection Readiness, Project/initiative coordination and management skills, Spotfire and Excel skills/experience
Benefits
- 401(k) plan with Pfizer Matching Contributions
- Additional Pfizer Retirement Savings Contribution
- Paid vacation
- Holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits including medical, prescription drug, dental and vision coverage
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