R&D Quality Director: GxP Audits & Inspection Readiness

Gilead Sciences Europe Ltd.; Uxbridge; On-site; GBP 50,000 - 70,000; Full time

Job summary

A biopharmaceutical company is seeking a candidate for the role focused on leading GxP audits and overseeing compliance activities. You will manage both routine and complex audit activities, define plans for auditors, and ensure regulatory readiness. The successful applicant will have a strong background in biopharma compliance, understand QMS operations profoundly, and be capable of addressing CAPAs effectively. This role requires the ability to travel up to 50%.

Qualifications

• Significant experience in biopharma quality, compliance, audits, inspections, and CAPA management.
• Preferred: GCP, GCLP, and GPV auditing and inspection experience.
• Ability to travel 40-50%.

Responsibilities

• Lead and execute internal GxP audits across multiple projects.
• Manage routine and complex audit activities, ensuring timely completion.
• Define audit plans and oversee contract auditors' activities.
• Evaluate SOPs and systems for regulatory compliance and readiness.
• Develop and manage CAPAs and deviations with cross-functional teams.

Skills

GxP compliance

Audit management

Regulatory inspection

CAPA management

Interpersonal skills

Analytical skills

Education

BA / BS or advanced degree in life sciences

Job description

A biopharmaceutical company is seeking a candidate for the role focused on leading GxP audits and overseeing compliance activities. You will manage both routine and complex audit activities, define plans for auditors, and ensure regulatory readiness. The successful applicant will have a strong background in biopharma compliance, understand QMS operations profoundly, and be capable of addressing CAPAs effectively. This role requires the ability to travel up to 50%.