Senior Manager, GD GCP Auditing

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

📋 Description

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

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

• Design and implement risk-based audit strategies for assigned clinical trials.

• Detect compliance issues and promote process enhancements and standardization.

• Act as a representative of Quality Assurance on intricate compliance projects and initiatives.

• Analyze policies, standards, and regulations to address significant concerns.

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

• Partner with Global Development teams, external collaborators, and quality stakeholders.

• Establish trusted relationships with stakeholders.

⛳️ Requirements

• Bachelor’s degree with 8+ years of pertinent industry experience; Master’s degree is preferred.

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

• In-depth knowledge of FDA regulations, European Union regulations, ICH guidelines, and GCP standards.

• Proven experience in conducting audits of processes, sites, vendors, and partners.

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

• Capability to independently handle complex GxP compliance issues and prioritize high-value tasks.

• Strong leadership abilities with experience engaging with senior leadership.

• Exceptional project management, stakeholder management, collaboration, and negotiation skills.

• Strong problem-solving capabilities along with excellent written and verbal communication skills.

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

• High level of attention to detail, accuracy, and organizational awareness.

• Willingness to travel 30-40% both domestically and internationally.

🏝️ 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 where necessary.

• Flexible remote work model.