QC Manager – GMP Analytics & Compliance (Equity Eligible)

Socket.dev; San Diego (CA); On-site; USD 120,000 - 164,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive program

Health benefits

Retirement plan with company match

Job summary

Neurocrine Biosciences is seeking a QA/QC leader to oversee GMP analytical testing at contract sites and internal labs in San Diego. You will review API and drug product records, stability data, validation protocols, and equipment qualifications to ensure compliance with CGMP and regulatory requirements.

You'll work with cross-functional teams, external labs, and manufacturing sites, lead deviation investigations, manage change controls, and prepare management reports.

Qualifications

• BS/BA in life sciences or related field with 6+ years in Pharma/Biotech OR
• Master’s in life sciences or related field with 4+ years of experience
• Strong team player with ability to drive results
• Ability to manage multiple deadlines with high accuracy
• Experience with CGMP and regulatory compliance in QC
• Experience with analytical development/testing and data management

Responsibilities

• Review API and drug product analytical records for clinical and commercial products
• Review stability data supporting retest period for products
• Review test method validation protocols and reports
• Review equipment qualification, calibration, and maintenance records
• Lead/develop deviation and investigation teams
• Facilitate change control processes for analytical changes
• Prepare management reports with key stats from analytical reviews
• Author/review SOPs, methods, protocols, and regulatory documents
• Conduct audits of external vendors and support inspections

Skills

Quality systems

CGMP

Regulatory compliance

Leadership

Data management

Analytical testing

Document control

Team collaboration

Problem-solving

Communication

Auditing

Education

BS/BA in Life Sciences

Master’s in Life Sciences

Tools

LIMS

EDMS

ELN

MS Excel

Job description

Neurocrine Biosciences is seeking a QA/QC leader to oversee GMP analytical testing at contract sites and internal labs in San Diego. You will review API and drug product records, stability data, validation protocols, and equipment qualifications to ensure compliance with CGMP and regulatory requirements.

You'll work with cross-functional teams, external labs, and manufacturing sites, lead deviation investigations, manage change controls, and prepare management reports.