Senior QA Leader - GxP, CMC & Outsourced QA (Hybrid)

Barrington James; Oxford; Hybrid; GBP 70,000 - 100,000; Full time

Job summary

Barrington James is recruiting a Senior QA Manager for a growing biotechnology client. The role provides broad QA leadership across GMP, GDP and GCP, with oversight of outsourced activities spanning CMC, manufacturing, testing, clinical supply and development.

The successful candidate will work closely with internal and external teams to drive a pragmatic, risk-based QMS that supports the company’s clinical and development programs. Hybrid role requiring onsite presence three days per week.

Qualifications

• 8+ years of QA/GxP experience in pharma/biotech.
• Degree in a life science or related field.
• Extensive GMP/GDP knowledge with GxP QA experience.
• Experience overseeing CROs, CMOs/CDMOs and labs.
• Experience with regulatory inspections and QMS improvements.

Responsibilities

• Provide QA leadership across GMP, GDP and GCP activities.
• Develop and improve risk-based QA policies, processes and systems.
• Maintain the Quality Management System to meet evolving requirements.
• Oversee QA of outsourced development, manufacturing, testing and clinical supply.
• Establish quality governance with external partners and negotiate quality agreements.
• Manage vendor audits, CAPAs, deviations and change controls.
• Lead risk assessments and ensure effective corrective actions.

Skills

QA leadership

GxP experience

GMP/GDP/GCP

Vendor governance

Audits

Education

Science degree

Job description

Barrington James is recruiting a Senior QA Manager for a growing biotechnology client. The role provides broad QA leadership across GMP, GDP and GCP, with oversight of outsourced activities spanning CMC, manufacturing, testing, clinical supply and development.

The successful candidate will work closely with internal and external teams to drive a pragmatic, risk-based QMS that supports the company’s clinical and development programs. Hybrid role requiring onsite presence three days per week.