Interim GMP QA Site Leader – Onsite in SoCal

The FDA Group; Los Angeles (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

The FDA Group is seeking an experienced Interim Quality Assurance Site Head to provide director-level quality leadership for a GMP contract testing laboratory in Southern California. This onsite role oversees cGMP systems, data integrity, investigations, CAPA, and inspection readiness while partnering with site leadership.

Ideal candidates have extensive QA leadership experience in pharma/biotech GMP environments, with a proven track record hosting regulatory inspections and client audits, plus

Qualifications

• Minimum 15 years of experience in pharmaceutical/biotech/GMP labs.

Responsibilities

• Lead daily QA activities for GMP analytical lab operations.
• Provide cGMP compliance leadership across site operations.
• Oversee QA management reviews and escalate quality risks.
• Ensure data integrity across systems and electronic records.
• Oversee change controls, deviations, OOS/OOT investigations, CAPAs.
• Coordinate GMP training and customer/client audits.
• Prepare for regulatory inspections and act as primary QA representative.
• Develop and mentor QA personnel and drive quality culture.

Skills

Quality leadership

Regulatory inspections

Data integrity

GMP compliance

Project management

Team leadership

Risk management

Analytical methods

Decision making

Communication

Education

Bachelor's degree in a scientific discipline

Tools

LIMS

Chromatography data systems

EDMS / electronic records systems

Electronic signatures

CAPA tracking systems

Job description

The FDA Group is seeking an experienced Interim Quality Assurance Site Head to provide director-level quality leadership for a GMP contract testing laboratory in Southern California. This onsite role oversees cGMP systems, data integrity, investigations, CAPA, and inspection readiness while partnering with site leadership.

Ideal candidates have extensive QA leadership experience in pharma/biotech GMP environments, with a proven track record hosting regulatory inspections and client audits, plus