Senior Clinical QA Program Lead: Audit & Compliance

Johnson & Johnson; High Wycombe; On-site; GBP 90,000 - 120,000; Full time

Job summary

Johnson & Johnson is seeking a Manager, Clinical QA Program Lead to drive audit strategies and oversee QA audits across therapeutic areas. The role requires coordinating with inspection readiness teams and providing expert guidance on CAPAs within GxP environments.

The position may involve global collaboration and on-site work, with a focus on maintaining regulatory compliance and audit excellence within clinical programs.

Qualifications

• Bachelor’s degree or equivalent required.
• 5+ years in compliance or related GxP/R&D.
• Experience conducting GCP audits.
• Experience developing audit strategies for GCP programs.
• Onsite 3 days/week at Johnson & Johnson location.

Responsibilities

• Drives and delivers audit strategies and capabilities for applicable therapeutic program levels and audits.
• Leads domain-specific QA audits, planning, execution, and reporting.
• Supports inspection readiness and coordination with Health Authority inspections.
• Takes active project management role, guiding priorities, deadlines and milestones.
• Provides expert input on CAPAs and risk management within audit programs.
• Mentors auditors and ensures regulatory and process compliance.

Skills

Compliance experience

GCP audits

Audit strategy development

Onsite work

Education

Bachelor’s degree

Job description

Johnson & Johnson is seeking a Manager, Clinical QA Program Lead to drive audit strategies and oversee QA audits across therapeutic areas. The role requires coordinating with inspection readiness teams and providing expert guidance on CAPAs within GxP environments.

The position may involve global collaboration and on-site work, with a focus on maintaining regulatory compliance and audit excellence within clinical programs.