Senior Manager, GCP Auditing

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

📋 Description

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

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

• Create and implement risk-based audit programs tailored for assigned clinical studies.

• Detect compliance issues and promote process improvements and standardization.

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

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

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

• Work in collaboration with Global Development teams, external partners, and quality stakeholders.

• Foster trusted partnerships with stakeholders.

⛳️ Requirements

• Bachelor's degree with over 8 years of pertinent industry experience; a Master's degree is preferred.

• A minimum of 5 years of direct experience in auditing Good Clinical Practices.

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

• 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 interacting with senior leadership.

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

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

• Capacity to work autonomously, take initiative, and excel in ambiguous situations.

• High level of attention to detail, precision, and organizational insight.

• 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 medical, dental, vision, life, and disability insurance benefits.

• Paid time off.

• Family support benefits.

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