Senior Manager GD GCP Auditing

Overview

The organization is seeking a Senior Manager, GD GCP Auditing to join the Global Development Quality Assurance team in a remote work model.

This role leads risk-based quality auditing activities and supports strengthening GCP compliance while partnering with Global Development teams, external partners, and quality stakeholders.

Responsibilities

• Lead end-to-end GCP audits across internal and external global activities.
• Schedule, conduct, report on, 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.
• Interpret policies, standards, and regulations to address critical issues.
• Support regulatory inspections and inspection room activities.
• Build trusted stakeholder partnerships in a dynamic environment.

Requirements

• Bachelor’s degree with 8+ years of relevant industry experience; Master’s degree preferred.
• At least 5 years of direct Good Clinical Practice (GCP) audit experience.
• Expert knowledge of FDA regulations, European Union regulations, ICH guidance, and GCP requirements.
• Experience conducting audit types including process, site, vendor, and partner audits.
• Experience with regulatory inspections involving investigator sites, sponsors, or Contract Research Organizations.
• Ability to independently manage complex GxP compliance issues and high-value priorities.

Preferred Qualifications

• Strong leadership skills with experience interfacing with senior leaders.
• Excellent project management, stakeholder management, collaboration, and negotiation skills.
• Strong problem-solving, written, and verbal communication skills.
• Ability to work independently, take initiative, and perform effectively in ambiguous environments.
• High attention to detail, accuracy, and organizational awareness.

Compensation & Benefits

• Salary Range (annually): Not provided in the posting.
• Final offer will be determined within the relevant range based on the country of employment, specific role level, and the candidate’s skills and experience.
• Total rewards may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (medical, dental, vision, life, and disability), paid time off, and family support benefits.

Location & Work Model

• Location: United States
• Work model: Remote
• Travel: 30–40% domestically and internationally.

Equal Opportunity & Accommodations

The organization is an equal opportunity employer and provides consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Reasonable accommodations may be provided to applicants with known disabilities or chronic illnesses during the recruitment process, unless doing so would impose undue hardship.

Additional Notes

• Background checks may be conducted in accordance with the laws of the country where the position is based.
• For Canada: this posting is for an existing position.