Director, Clinical QA – Clinical Quality Assurance

Job Description

Director, Clinical Quality Assurance | Neurocrine Biosciences

The Tone:
This is a full-time role at Neurocrine Biosciences, location not specified in listing. Neurocrine Biosciences discovers, develops, and commercializes treatments for people with neurological, psychiatric, endocrine, and immunological disorders. This Director role is critical for developing and executing strategy for Clinical Quality Assurance, ensuring compliance, and providing quality leadership across clinical study teams. The person in this role will build and lead a skilled team, playing a key part in regulatory inspections and maintaining high quality standards.

The TL;DR
• Role: Full Time
• Type: Full-time
• Location: Not specified in listing
• Team: Leads a team of highly trained and skilled quality managers, specialists, and associates.
• Mission: Develop and execute strategy for Clinical QA, establish compliance, procedures, and quality leadership.

What You’ll Actually Do
• Strategy Development: Develop and execute strategy for Clinical QA and establish strong, effective working relationships with internal and external stakeholders to achieve GCP compliance and Quality objectives.
• Vision Leadership: Lead efforts in developing, implementing, and communicating the GCP QA vision, goals, core capabilities, and value while championing a strong Quality Culture.
• Stakeholder Partnership: Partner with Clinical Development, Clinical Operations, Biostatistics, Pharmacovigilance, and Regulatory Affairs stakeholders regarding compliance issues and provide quality guidance and expert interpretation of GCP regulatory requirements.
• Regulatory Inspections: Lead preparations and direct participation in regulatory inspections, which includes reviewing inspection readiness planning, mock inspections, performance of pre-approval inspections, and risk-based management of program inspection quality events.
• Vendor Oversight: Participate in the evaluation, selection, compliance audit strategy, and oversight of global clinical investigators, contract clinical laboratories, and CROs.

The Must-Haves
• Background: RN, BSN, BS/MS, or BA degree or equivalent experience in a scientific or health care field, assuming a Director-level career.
• Experience: 12+ years of industry experience including GCP leadership roles within development and commercial GCP environments, or 10+ years with a Master’s Degree. Extensive GCP audits and inspections experience is required, alongside previous managerial experience and experience developing and implementing GCP QA systems, processes, and procedures.
• Skills: In-depth knowledge of all Clinical Trial related FDA regulations, ICH Guidelines, and international GCP regulations. Ability to create a comprehensive audit program and conduct audits of investigator sites and clinical research vendors for Phase I-IV studies. Strong knowledge and expertise in GCP, as well as GLP and/or GMP systems throughout the product lifecycle. Excellent interpersonal skills and competent communication when interacting with regulatory authorities, internal leaders, and external partners.
• Bonus: Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization. Ability to mentor, be a trusted advisor, and an advocate for Quality with the ability to influence change, demonstrating a record of overcoming resistance and driving adoption of new processes.