Global Head of Clinical Quality
Description
Our client is a respected mid-size Pharma with a very bright future across multiple therapeutic areas. They are stable and offer an employee-friendly work environment. This is an attractive opportunity to lead a Global Clinical Quality/Compliance/Performance department across strategy, tactics, cross-functional management and also people management. You will have full responsibility across the entire global early clinical development group to also include PV.
Location
New Jersey area. This is a full-time in-house position without a hybrid or remote/work-from-home option.
Responsibilities
- Leadership to the Clinical Quality/Compliance/Metrics department to include strategy, people management and operational excellence.
- Improve, create and implement Quality Systems, Manuals, etc.
- Develop a risk assessment strategy aligning with corporate risk management strategy ensuring timely, effective, and consistent execution of the risk strategy, including mitigating risk.
- Interface with regulatory authorities/agencies as required, to include inspections.
- Serve as a Global Clinical Quality representative on various cross-functional teams.
- Oversight/leadership for issues/risks/trends/process improvement opportunities and ensure that they are appropriately communicated back to the business partners, and effectively addressed.
- Ensure that appropriate quality and compliance metrics are in place, are being measured, and are being consistently tracked and reported on.
- Provides quarterly reports for management review on the status of compliance, and quality standards of all facilities, processes, procedures and practices.
- Accountable for leadership, strategic oversight and expert input on all quality and compliance issues arising on clinical studies and ensures appropriate corrective and preventative action plans are defined and implemented.
- Analyze and interpret clinical (GCP and GVP) quality and compliance metrics and audit findings.
- Establish and maintain GCP training.
- Lead inspection activities as well as any inspection readiness-related activities.
Qualifications / Requirements
- Advanced degree (MS, PhD, PharmD, etc) is required.
- 15+ years of relevant experience within Clinical Quality, Compliance and/or Performance Metrics/Improvement.
- Direct report experience.
- Ability to lead and collaborate with multi-disciplinary teams.
- Must be able to see the bigger picture (ie. strategic perspective, global orientation, collaborative thought process, etc.).
Contact
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