Senior Clinical QA Leader - Equity & 30% Bonus

Biopharma Careers; San Diego (CA); On-site; USD 149,000 - 203,000; Full time

Benefits offered by this job

Retirement plan with company match

Health benefits

Paid vacation and holidays

Job summary

Neurocrine Biosciences is seeking a Clinical Quality Assurance lead to drive and oversee GCP audits across multiple programs. You will manage audit plans, maintain records, and provide metrics to management, while leading complex QA efforts and providing training as needed.

The role requires strong knowledge of FDA/ICH guidelines, excellent communication and leadership skills, and the ability to coordinate with cross-functional teams to ensure GMP-like quality in clinical development.

Qualifications

• BA/BS in life sciences or RN and 8+ years in industry preferred, with 4 years in CQA in drug development.
• Master's degree in life sciences with 6+ years relevant experience.
• Strong knowledge of regulatory requirements and guidelines (FDA, ICH).
• Excellent leadership and mentoring skills; ability to lead multiple teams.

Responsibilities

• Lead, plan, conduct, and oversee GCP audits (vendor, site, internal).
• Develop and execute audit plans in line with QA annual plans.
• Maintain audit records and provide status reports to management.
• Serve as CQA lead for complex programs, including unblinded roles.
• Lead site inspection prep and review findings with QA management.
• Provide GCP training as needed.

Skills

GCP knowledge

Audit management

Regulatory knowledge

Leadership

Communication skills

Problem solving

Project management

Attention to detail

Education

BA/BS in life sciences or RN

Master's in life sciences

Job description

Neurocrine Biosciences is seeking a Clinical Quality Assurance lead to drive and oversee GCP audits across multiple programs. You will manage audit plans, maintain records, and provide metrics to management, while leading complex QA efforts and providing training as needed.

The role requires strong knowledge of FDA/ICH guidelines, excellent communication and leadership skills, and the ability to coordinate with cross-functional teams to ensure GMP-like quality in clinical development.