Clinical Quality Director Job

Clinical Quality Director

Requisition 80760
Category Clinical Studies
Business Corporate-US Headquarters
Division Corporate Clinical
Location USA-MN-Fridley
Relocation Relocation eligibility to be determined
Job Type Full Time - Regular
Exempt/Non-Exempt Exempt
Shift First
Travel Percentage 10 - 20%
Experience Required 10+ years
Education Required Bachelors Degree

Medtronic is an Equal Opportunity/Affirmative Action Employer


Position Description

The Director of Clinical Quality develops and administers the enterprise clinical quality strategy, the global clinical quality system, enterprise SOPs, and training to ensure organizational compliance to regulatory requirements

The Director will have overall responsibility to assure initiatives related to quality and compliance are optimized and executed appropriately to meet the changing needs of the global clinical/regulatory requirements.

Position Responsibilities

- Responsible for overall management and strategic global direction of the MCRI Central Quality function including clinical audits, supporting businesses on compliance issues, and quality training of the MCRI Central staff.
- Provide direction for the MCRI Central Quality Department in implementing a risk based auditing approach to provide verification of compliance for MCRI activities.
- Keep current on regulatory requirements that are applicable to clinical research, and lead the establishment of appropriate, accurate, and consistent policies and procedures for clinical research/operations globally
- Establish effectiveness checks for processes and implement process improvements when and where needed.
- Oversee the vigilance staff and actively contribute to talent acquisition and talent management for the department. Responsible for department cost center and development of Annual Operating Plans (AOP).
- Communicate quality activities, findings, and metrics to appropriate stakeholders (ExCom, Clinical Council, regulatory, QA personnel, etc.) in a timely manner. Provide recommendations for process change to meet new/upcoming requirements.
- Establish working relationship with international partners – both internal and external to Medtronic - to develop an effective global plan for clinical quality activities.
- Ensure departmental compliance as well as appropriate departmental resources are available to effectively maintain the quality system (people, facilities, tools, and training).

Basic Qualifications

- Bachelor’s degree in health care or related biological/engineering field.
- 10 years Clinical research or Quality experience (specifically Compliance, Audit, or Field Assurance) in drugs, devices, and/or combination products or 8 years with Masters degree
- 5 years of people management/leadership experience in directing clinical research or Quality (specifically Compliance, Audit, or Field Assurance) organizations.
- Experience in developing annual operating plans and managing cost centers
- Experience with the application of FDA/ICH clinical requirements

Desired/Preferred Qualifications

- Graduate degree in Public Health, epidemiology, or M.D.
- 7 years of progressive leadership experience
- Mastery of the global standards and requirements governing human research and the integrative role of clinical quality (ISO 14971, ISO 14155, ISO 13485, ICH Good Clinical Practice Guidelines, U.S. Code of Federal Regulations 21 CFR Part 812 (or 21 CFR Part 312), current Good Manufacturing Practices, etc)
- Previous experience designing and successfully leading a broad clinical quality function in medical device and/or pharmaceutical industry (structure, policies/procedures, training, process improvement)
- Demonstrated strong analytical skills and appropriate use of clinical judgment.
- Excellent communication (written and verbal) skills

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers

Nearest Major Market: Minneapolis
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