Vice President, Head of Quality

Summary Description

The Vice President, Head of Quality will lead and direct the quality assurance, quality control and GXP compliance functions at Geron. As Responsible Person, the incumbent will assure compliance for all clinical studies and manufacturing operations in accordance with domestic and international requirements for current Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) through late-stage development, licensure, and commercialization in the US, Europe, and other regions. The Head of Quality will take a cohesive team approach to quality assurance, interacting closely with corresponding functional executives within the company. The position reports directly to the Executive Vice President, Development & Technical Operations.

Job Description

  • Develop the Company’s quality vision and commitment internally and implementing that vision in interactions with partners, clinical research organizations, manufacturers, and suppliers
  • Provide strategic leadership for oversight and compliance with GXP internally and at our third party contract research organization (CRO), contract manufacturing organizations (CMOs), quality control laboratories, and other GCP and GMP vendors and suppliers, for clinical operations, clinical trial management, clinical development, and manufacturing
  • Oversee and direct negotiations of quality issues per established agreements and assure compliance with all quality and compliance aspects of clinical research and manufacturing contracts
  • Champion a corporate-wide quality management system encompassing all policies, practices, procedures and specifications for non-clinical, clinical, and CMC activities, with a world-wide commercialization perspective
  • Manage continued development and refinement of risk management strategies and plans related to clinical trial conduct, vendor oversight, quality improvement, and overall GXP compliance
  • Assure Quality review and input on clinical and manufacturing documentation both internally and at third party partners, to support responses to regulatory agency questions, address clinical and CMC related regulatory feedback, and support worldwide regulatory submissions and marketing applications
  • Implement employee communication and training programs in connection with the Company’s Quality objectives, strategies and processes
  • Continued development, improvement and effectiveness checks of processes and systems for compliance with GXPs
  • Hiring, development and mentoring of Quality staff
  • Assess and align the organization to meet the goals of the long-range business plan

Qualifications

  • Advanced Degree in science with appropriate post-graduate leadership and management training
  • 15 + years’ experience in pharmaceutical or biopharmaceutical quality operations including late-stage clinical studies, complex molecules, and sterile dosage forms
  • Extensive Quality Assurance management experience in a late-stage clinical setting, including GXP oversight of third parties, internal quality system development and operations, product quality oversight, discrepancy investigation and management, and PAI preparation, conduct, and follow-through
  • Detailed knowledge and in-depth application of GXP and ICH, USP/EP, and FDA/EMEA regulations and international guidelines
  • Strong domestic and international regulatory inspections and compliance background
  • Background knowledge of analytical and bio-analytical assay development
  • NDA/MAA preparation and product registration and commercialization experience
  • Track record managing activities to timelines, leading and developing people, working in a multi-disciplinary team environment
  • People management strengths, including the ability to motivate and mentor
  • Excellent written and verbal communication skills
  • Excellent scientific analysis and interpretation skills and the ability to creatively problem solve