Manager, Clinical Quality and Compliance

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of .

• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

• An excellent retirement savings plan with high employer contribution

• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Portland, Maine location.  The position of Manager, Clinical Quality and Compliance s within our Infectious Disease business unit. In this role, the Manager of Clinical Quality and Compliance will provide guidance and support for ARDx ID Clinical Operations including oversight of clinical quality activities and ensure clinical trials are conducted in a manner compliant with SOPs, ICH/GCP/regulatory guidelines and company goals. 
 

What You’ll Work On

• Identify, communicate and provide solutions to clinical trial issues and/or risks.

• Ensure clinical quality and compliance team members are aligned with project objectives.

• Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and procedures.

• Ensure the execution of training plans, SOP review, and understanding and adherence to SOP training matrix.

• Ensure quality deliverables, including identifying quality risks, and developing corrective action plans to prevent and/or correct deficiencies.

• Maintain current knowledge of therapeutic areas, SOP’s, IVDR and ICH-GCP guidelines.

• Oversee management of clinical quality documentation, ensuring all policies and procedures are current and compliant.

• Identify and develop risk management and contingency plans.

• Participate in vendor selection process for outsourced activities as applicable.

• Responsible for clinical quality incident reporting, corrective and preventative actions, and supplier corrective action requests.

• Share and promote the best practices within the team to enhance performance.

• Carry out duties in compliance with established business policies.

• Assist in developing regulatory approach to market clearance. Prepare and/or provide review of submission documentation for clinical trials and/or product clearance as needed.

• Support regulatory audits and inspections.

• Interact with other managers across multiple functional areas to facilitate smooth work processes and communication. This may include involvement in the design change process and quality system regulation.

• Provide ongoing training for staff and develop (in conjunction with the Director, Global Clinical Operations) performance metrics, as well as communicate and implement performance goals aligned with corporate strategic imperatives.

• Mentor/coach direct up to 5 reports.

• Contribute to the selection process of new hires, including reviewing candidate credentials, interviewing candidates, and making hiring recommendations. Recruit, hire, train, and manage assigned MCSO personnel and their career development.

Required Qualifications:

• BS/BA degree in science or related field.

• 8+ years’ experience in Good Clinical Practice (GCP) and/or Quality Assurance Environment, including 5+ years clinical study/project management experience

• Broad knowledge of IVDR, ICH, GCP, IRB/IEC, and local regulatory authority for diagnostic & ass