Senior Manager, GD, GCP Auditing

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Oversee comprehensive GCP audits for both internal and external global operations.

• Plan, execute, document, and follow up on routine and targeted audits.

• Create and implement risk-based audit frameworks for designated clinical trials.

• Detect compliance challenges and promote process enhancements and standardization.

• Serve as the Quality Assurance representative on intricate compliance projects and initiatives.

• Analyze policies, standards, and regulations to resolve critical issues.

• Assist in regulatory inspections and activities within the inspection room.

• Work in partnership with Global Development teams, external collaborators, and quality stakeholders.

• Establish reliable partnerships with stakeholders.

⛳️ Requirements

• A Bachelor’s degree accompanied by 8+ years of pertinent industry experience; a Master’s degree is preferred.

• Minimum of 5 years of direct experience in Good Clinical Practice auditing.

• In-depth understanding of FDA regulations, European Union regulations, ICH guidance, and GCP requirements.

• Proven experience in executing process, site, vendor, and partner audits.

• Familiarity with regulatory inspections involving investigator sites, sponsors, or Contract Research Organizations.

• Capability to independently navigate complex GxP compliance challenges and prioritize high-value tasks.

• Strong leadership abilities with experience in engaging with senior management.

• Excellent skills in project management, stakeholder engagement, collaboration, and negotiation.

• Proficient problem-solving, writing, and verbal communication skills.

• Ability to work autonomously, take initiative, and thrive in ambiguous situations.

• Keen attention to detail, accuracy, and organizational awareness.

• Willingness to travel domestically and internationally 30-40% of the time.

🏝️ Benefits

• Annual bonuses or other incentive plans.

• Equity awards.

• Pension or retirement benefits.

• 401(k) company match.

• Health and wellness programs.

• Access to fitness centers.

• Comprehensive insurance benefits (e.g., medical, dental, vision, life, and disability).

• Paid time off.

• Family support benefits.

• Reasonable accommodations during the recruitment process for applicants with known disabilities or chronic illnesses.