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Senior Director Clinical Quality Assurance
147487
Posted:
29/07/2024th
29/07/2024
- 240000 USD - 240000 USD
- South San Francisco, United States
- Permanent
We are partnering with an Auto-Immune biotech to find them a Senior Director of Clinical Quality Assirance. This role demands proficiency in Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GVP), along with pertinent US and EU regulations. The ideal candidate will cultivate, advocate for, and integrate a culture of ethics, integrity, and proactive quality management. They will offer guidance and leadership to ensure the quality function upholds the standards mandated by global regulatory bodies.
Responsibilities:
- Develop and sustain GCP QA programs, policies, and procedures.
- Ensure ongoing clinical programs comply with relevant health authority regulations and guidelines.
- Serve as the primary GCP QA expert and contact for all GCP/GVP-related issues.
- Establish audit plans specific to each study; conduct audits and oversee external quality auditors as necessary.
- Represent Quality in project teams, Health Authority Inspections, operational meetings with service providers and CROs, and QA-to-QA meetings.
- Manage content and materials for Quality Review Board meetings. Prepare KPIs and metrics.
- Provide quality oversight and review key Clinical and IND/NDA enabling documents.
- Review clinical trial documentation for data integrity and compliance with GCP guidance and regulations. Conduct root cause analyses for recurring issues.
- Develop strategies for and lead the implementation of inspection readiness plans and activities. Act as the primary liaison with Health Authorities and internal/external business partners.
- Support the selection and qualification of clinical service providers and develop periodic compliance/metric reports.
Requirements:
- Bachelor's or advanced degree in Biology, Chemistry, or a related field.
- Minimum of 12 years of GCP/GVP Quality Assurance experience.
- Strong understanding of small molecule products, with direct experience in solid oral dosage forms.
- Extensive knowledge of FDA regulations and practices, ICH guidance, and global health authority regulations and practices.
- Hands-on experience in drug life cycle management.
- Proven track record of working with service providers and CROs.
- Ability to make timely and sound quality decisions when faced with complex clinical, compliance, technical, and regulatory considerations. Highly skilled in managing ambiguity and complexity.
- Knowledge of Quality Management Systems; experience in implementing and managing quality systems in the pharmaceutical industry.
- Excellent verbal and written communication skills.
- Collaborative, analytical, and interpretative skills.
- Ability to work independently, set priorities to meet deadlines, and motivate and influence others. Prior management experience is required.
- Previous experience in successfully leading activities within cross-functional teams.
- Some travel is required.
Martin Wenzel
Division Director