Senior Manager, GCP Audit Strategy, Global Development (GCP)

Location: Remote in the United Kingdom or Ireland; 10–20% travel may be required.

Company

Science-driven biotechnology organization developing medicines for people with serious diseases.

What you will do

• Lead risk-based audit planning across therapeutic areas and clinical studies.
• Drive strategic audit programs using risk indicators from study teams.
• Ensure audits align with approved programs and scheduled timelines.
• Manage audit outcomes, identify trends, and communicate quality risks.
• Represent quality assurance on complex cross-functional initiatives.
• Deliver reports and metrics to Global Development leadership.

Requirements

• Bachelor’s degree and 8+ years of relevant industry experience.
• 5+ years of GCP audit strategy or audit experience.
• Knowledge of FDA, EU, and ICH GCP regulations and guidance.
• Experience supporting or participating in regulatory inspections.
• Strong project management, stakeholder management, and communication skills.
• Ability to collaborate across global functions and prioritize multiple complex activities.

Culture & Benefits

• Remote work arrangement for candidates in the United Kingdom or Ireland.
• Inclusive workplace and equal employment opportunity commitment.
• Competitive total rewards package may include bonuses, equity, pension or retirement benefits, insurance, paid time off, and family support benefits.
• Background checks may verify identity, right to work, and educational qualifications where required.