Asset Quality Lead, Director – FSP
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Job Description
Asset Quality Lead driving GCP Quality for clinical trial programs at Parexel. Collaborating within cross-functional teams to ensure quality oversight and regulatory compliance.
Responsibilities:
- Responsible for driving GCP Quality for clinical trial programs/protocols.
- Ensure program and study level quality oversight, drive quality risk management and inspection readiness.
- Serve as GCP quality expert to study teams.
- Oversee study-level quality risk management activities, including driving Study Risk Profile development.
- Provide guidance and support to asset teams for Inspection Readiness aligned with business development opportunities.
- Advise asset/study teams on appropriate escalation pathways for quality concerns.
Requirements:
- A scientific or technical degree is preferred.
- BS: 10+ years or equivalent experience
- MS/MBA: 7+ years or equivalent experience.
- Strong, advanced knowledge in ICH GCP, clinical trial development, and operational GCP quality management.
- Familiarity with relevant key therapeutic areas.
- Strong interpersonal skills and ability to influence.
- Experience working on global initiatives or project teams.
Benefits:
- Parexel offers an empathetic work environment.
- Contributes to the development of therapies that benefit patients.
- Opportunity to work with biopharmaceutical leaders and emerging innovators.
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