Senior Manager, Clinical Compliance

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

📋 Description

• Oversee quality assurance and compliance operations within your domain, ensuring your team meets the highest standards.

• Create and execute quality assurance strategies and processes to enhance clinical trial activities.

• Perform thorough quality evaluations and audits to guarantee adherence to regulatory standards and guidelines.

• Work collaboratively with cross-functional teams to pinpoint and resolve quality concerns, implementing corrective measures as necessary.

• Engage in the review and endorsement of clinical trial documentation and data to ensure precision and completeness.

• Offer leadership and guidance to quality assurance personnel, promoting a culture of excellence and ongoing improvement.

⛳️ Requirements

• Bachelor's degree in a relevant field.

• At least 7 years of experience in quality assurance within the pharmaceutical, biotechnology, or CRO industries, including a minimum of 3 years in a management or leadership capacity.

• Strong understanding of regulatory requirements and guidelines that govern clinical trials (e.g., ICH-GCP, FDA regulations).

• Excellent analytical and problem-solving abilities, capable of identifying and addressing complex quality issues.

• Outstanding communication and interpersonal skills, with the capacity to collaborate effectively with colleagues and stakeholders at all levels.

• Willingness to travel as necessary (approximately 35%).

🏝️ Benefits

• Various annual leave entitlements.

• A selection of health insurance options to meet the needs of you and your family.

• Competitive retirement planning options to enhance savings and confidently prepare for the future.

• Global Employee Assistance Programme, TELUS Health, providing 24-hour access to a worldwide network of over 80,000 independent specialized professionals dedicated to supporting your and your family’s well-being.

• Life assurance.

• Flexible, country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, and more.