Senior Manager GD GCP Auditing (GCP)

Location: United Kingdom; remote work model. Willingness to travel 30–40% domestically and internationally is required.

Company

Develops science-driven medicines intended to improve outcomes for people with serious diseases.

What you will do

• Lead end-to-end GCP audits across internal and external global development activities.
• Schedule, conduct, report, and follow up on routine and directed audits.
• Develop and execute risk-based audit programs for assigned clinical studies.
• Identify compliance issues and drive process improvements and standardization.
• Represent Quality Assurance on complex compliance projects and initiatives.
• Support regulatory inspections and inspection-room activities while partnering with development teams, external partners, and quality stakeholders.

Requirements

• Bachelor’s degree and 8+ years of relevant industry experience; a master’s degree is preferred.
• At least 5 years of direct Good Clinical Practice audit experience.
• Expert knowledge of FDA and European Union regulations, ICH guidance, and GCP requirements.
• Experience conducting process, site, vendor, and partner audits.
• Experience with regulatory inspections involving investigator sites, sponsors, or Contract Research Organizations.
• Strong leadership, project management, stakeholder management, collaboration, negotiation, problem-solving, and communication skills, with the ability to work independently in ambiguous environments.

Culture & Benefits

• Remote work model supporting collaboration with global development and quality teams.
• Opportunity to contribute to a fast-growing, science-driven organization focused on serious diseases.
• Comprehensive rewards may include bonuses or incentive plans, equity awards, pension or retirement benefits, insurance, paid time off, and family support benefits, depending on country and role.
• Inclusive workplace with reasonable accommodations available where required by law.