Compliance Manager, Clinical Quality Assurance Oversight

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

📋 Description

• Oversee and support Clinical Quality for clinical study teams.

• Act as the exclusive Quality contact for the client.

• Collaborate with Operations to foster a uniform Quality culture across clinical trials or portfolios.

• Engage in regular partnership-level and ad hoc team meetings.

• Offer guidance and recommendations to prevent issues.

• Maintain ongoing awareness and periodically assess QE, SSM, SB, sPIP, audit, and inspection activities.

• Appropriately escalate matters to Client Quality, Quality Partner, Strategic Alliance Lead, bPL, PDL, or OD to reduce client impact and enhance outcomes.

• Enable and facilitate Quality Risk Management initiatives.

• Prepare and evaluate QA-related Key Quality Indicators to identify emerging trends and potential risks.

• Advocate for compliance with client-specific quality-event, audit, and inspection-response requirements.

• Integrate quality insights into operational lessons learned and raise awareness across the portfolio.

• Drive support for Partnership Governance.

• Co-chair Joint Quality Councils and participate in other governance meetings.

• Present quality metrics and trends and discuss possible resolutions with relevant stakeholders.

⛳️ Requirements

• Bachelor's degree or equivalent with relevant formal academic/vocational qualification.

• Over 8 years of experience in compliance and quality or comparable knowledge, skills, and abilities.

• Proficient understanding of Good Clinical Practices (GCP).

• Experience in the CRO/Pharma industry is essential.

• Comprehensive knowledge of FDA and EU regulations related to Clinical Trials and ICH Guidelines.

• Strong understanding of Clinical Development processes per GCP and regulatory requirements.

• Proven track record of building robust team and stakeholder relationships.

• Capability to motivate and educate clinical study teams on clinical quality aspects.

• Ability to convey quality culture and methodologies to study teams.

• Proficient in communicating, receiving, and comprehending information and ideas with diverse groups of people.

• Capability to work upright and stationary during regular working hours.

• Proficient in using and learning standard office equipment and technology.

• Ability to perform effectively under pressure while managing multiple projects or activities.

• Estimated travel requirement of 0–25%.

• Must be legally authorized to work in the United States without sponsorship.

• Must be able to pass a comprehensive background check, including drug screening.

🏝️ Benefits

• Fully remote, home-based position.

• Eligibility for variable annual bonuses based on company, team, and/or individual performance.

• Relocation assistance is not available.