Director, Clinical Quality Assurance

About the role

Neurocrine Biosciences, a biopharmaceutical company focused on neurological, psychiatric, endocrine and immunological disorders, is looking for a Director of Clinical Quality Assurance. The role develops strategy and operating plans for Clinical QA, sets up compliance, procedures and quality leadership, and leads a team of quality managers, specialists and associates. It also leads pre-approval inspections and clinical audits and coordinates with regulatory, clinical, drug safety and medical affairs.

Key responsibilities

• Develop the executive strategy for Clinical QA and build strong relationships with internal and external stakeholders to achieve GCP compliance and quality objectives
• Lead the development, implementation and communication of the GCP QA vision, goals and capabilities, and champion a strong quality culture
• Partner with Clinical Development, Clinical Operations, Biostatistics, Pharmacovigilance and Regulatory Affairs on compliance issues and interpret GCP requirements
• Take part in regulatory inspections, including inspection readiness planning, mock inspections, pre-approval inspections and managing inspection quality events
• Lead the development of the clinical QMSP and oversee the audit strategy, global clinical investigators, contract labs and CROs, and intervene when performance is sub-optimal
• Support IND, ex-US CTA and other submissions to global regulators, and develop metrics and trends of compliance activities
• Perform investigator site and vendor audits, and oversee compliance activities for drug safety, pharmacovigilance, phase IV studies and investigator-initiated trials
• Carry out internal audits of policies, procedures, systems and reporting against GCP principles

Required profile

• RN, BSN, BS/MS or BA degree or equivalent experience in a scientific or healthcare field, with 12+ years of industry experience including GCP leadership roles in development and commercial GCP environments
• OR a Master's degree in a similar field with 10+ years of experience as described
• Extensive GCP audits and inspections experience, and experience developing and implementing GCP QA systems, processes and procedures
• Previous managerial experience
• Recognized as an internal thought leader with extensive technical and business expertise

Required skills

• In-depth knowledge of Clinical Trial-related FDA regulations, ICH guidelines and international GCP regulations
• Broad knowledge of domestic and international regulations, with a focus on FDA and EMA
• Solid knowledge of GxP and of GCP, GLP and/or GMP systems throughout the product lifecycle
• Ability to create and run a comprehensive audit program for Phase I-IV studies
• Strong leadership, communication and interpersonal skills, with the ability to mentor, influence change and work with regulatory authorities