Sr. Clinical QA Manager

At Neurocrine Biosciences, we are seeking a Sr. Clinical QA Manager to lead Clinical Quality Assurance (CQA) activities in support of research projects across multiple therapeutic areas. The successful candidate will provide QA expertise, leadership, and training to ensure adherence with applicable regulatory requirements and company policies/procedures.

Requirements

• BA/BS in life sciences or related discipline or RN and 8+ years of related industry experience, including 4 years in CQA in drug development environment
• Expert knowledge of all Clinical Trial related FDA regulations and ICH Guidelines, and experience with international GCP regulations and guidelines
• Demonstrated ability to create a comprehensive audit program and carry out audits of investigator sites and clinical research vendors for Phase I-IV studies
• Ability to identify and escalate problems and follow-through with the corrective actions
• Excellent computer skills
• Excellent communication, problem-solving, analytical thinking skills
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency

Benefits

• Retirement savings plan (with company match)
• Paid vacation
• Holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits to include medical, prescription drug, dental and vision coverage