Senior QC Lead - GMP Analytics & Lab Oversight

Neurocrine Biosciences; San Diego (CA); On-site; USD 120,000 - 164,000; Full time

Benefits offered by this job

Retirement plan

Paid vacation

Medical benefits

Parental leave

Job summary

Neurocrine Biosciences seeks a QA/QC leader to oversee GMP analytical testing at internal labs and contract sites. You will review API and drug product records, validation reports, and equipment qualifications to ensure data integrity and compliance.

You'll lead deviation investigations, audits, and cross-functional collaborations to resolve testing issues and drive CGMP improvements. Strong data management and regulatory knowledge are essential.

Qualifications

• BS/BA in life sciences with 6+ years in pharma/biotech or MS with 4+ years in a similar role.
• Strong CGMP knowledge and data integrity focus.
• Experience with regulatory compliance and quality systems.

Responsibilities

• Review and approve API and drug product analytical records.
• Review stability data and validation protocols/reports.
• Lead deviation investigations and laboratory investigations.
• Interact with cross-functional teams and external labs to resolve issues.
• Prepare regulatory submission modules and audit support.

Skills

CGMP knowledge

Analytical testing

Quality systems

Leadership

Education

BS/BA in life sciences

MS in life sciences

Tools

LIMS

EDMS

Job description

Neurocrine Biosciences seeks a QA/QC leader to oversee GMP analytical testing at internal labs and contract sites. You will review API and drug product records, validation reports, and equipment qualifications to ensure data integrity and compliance.

You'll lead deviation investigations, audits, and cross-functional collaborations to resolve testing issues and drive CGMP improvements. Strong data management and regulatory knowledge are essential.