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Clinical Quality and Compliance Manager
2 months ago
About Abbott Laboratories
At Abbott Laboratories, we offer an environment where you can engage in meaningful work, pursue personal growth, and enjoy a balanced life.
Benefits You Will Enjoy:
- Career advancement opportunities within a global organization.
- Comprehensive medical coverage for employees through our Health Investment Plan (HIP) PPO.
- A robust retirement savings plan with significant employer contributions.
- Tuition reimbursement and programs like Freedom 2 Save for student debt relief, alongside our FreeU education benefit to support your pursuit of a bachelor's degree.
Abbott is consistently recognized as a top employer globally, celebrated for our commitment to diversity and inclusion, and acknowledged by Fortune as one of the most admired companies.
Position Overview
The role of Clinical Quality and Compliance Manager is integral to our Infectious Disease business unit. In this capacity, you will provide essential guidance and support for clinical operations, ensuring that clinical trials adhere to established standards and regulatory requirements.
Key Responsibilities:
1. Identify and address clinical trial challenges and risks.
2. Align clinical quality and compliance team efforts with project goals.
3. Ensure adherence to study protocols, SOPs, and ICH/GCP regulations.
4. Oversee training execution, SOP reviews, and compliance with training matrices.
5. Deliver quality outputs by identifying risks and formulating corrective action plans.
6. Maintain up-to-date knowledge of therapeutic areas and regulatory guidelines.
7. Manage clinical quality documentation, ensuring compliance with policies and procedures.
8. Develop risk management strategies and contingency plans.
9. Participate in vendor selection for outsourced activities as necessary.
10. Handle clinical quality incident reporting and corrective actions.
11. Foster best practices within the team to enhance overall performance.
12. Assist in the development of regulatory strategies for market clearance and support audit processes.
Qualifications:
• Bachelor’s degree in a scientific discipline or related field.
• Over 8 years of experience in Good Clinical Practice (GCP) and/or Quality Assurance, including 5 years in clinical project management.
• Extensive knowledge of IVDR, ICH, GCP, and local regulatory requirements for diagnostic and assay development.
Preferred Qualifications:
• Master’s degree is preferred.
• Minimum of 2 years in a management role within a similar context.
• Experience managing clinical trials in the biotech or medical device sectors, including CRO management and clinical site monitoring.
We are looking for a proactive leader with strong strategic thinking and problem-solving skills, capable of mentoring team members and driving performance aligned with corporate objectives.
Join Abbott Laboratories to explore diverse career opportunities that can help you shape your future and achieve your professional aspirations.
