Senior Manager, Clinical Compliance

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

📋 Description

• Oversee quality assurance and compliance functions within your area, ensuring that your team meets the highest standards.

• Create and execute quality assurance strategies and procedures to facilitate clinical trial operations.

• Perform thorough quality evaluations and audits to verify 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 guarantee accuracy and completeness.

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

⛳️ Requirements

• Bachelor's degree in a pertinent field.

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

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

• Strong analytical and problem-solving abilities, with the capability to identify and address complex quality issues.

• Outstanding communication and interpersonal skills, enabling effective collaboration with colleagues and stakeholders at all levels.

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

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.