Director, Quality Assurance Combination Products & Medical Devices
The Director, Quality Assurance Combination Products & Medical Devices provides strategic direction to ensure global quality expectations are met during the development of combination products and medical devices across a diverse range of devices essential for the advancement of the R&D pipeline. The Director manages a global team of quality professionals responsible for quality oversight of combination product/device development programs, and implements medical device regulations, where appropriate, with existing pharmaceutical processes.
- Provide quality oversight of all Combination Product and Medical Device projects to ensure products and data generated by R&D are in compliance with worldwide regulatory requirements and expectations.
- Engage a lifecycle approach, incorporating clinical and on-market expectations into development to enable seamless transfer, launch and ultimately success in the hands of our patients.
- Proactively engage external device development partners to ensure AbbVie quality expectations are communicated and achieved.
- Develop quality strategies to support early clinical involvement with delivery devices and digital in clinical solutions.
- Implement Design Control, Risk Management and ensure adherence to global combination product and medical device regulations.
- Ensure alignment where complex cross-functional interfaces exist such as with development, regulatory affairs, medical, operations, clinical, and commercial functions. Effectively manage across multiple management levels.
- Develop organizational model and ensure appropriate capabilities and resources exist.
- Monitor current trends of regulatory agencies as they apply to combination product/medical device development. Communicate the changing regulatory requirements, understand the impact of changes on other quality systems and manage and drive change.
- Advocate for Quality standards and clearly and logically justify such positions to be seen as a subject matter expert and advisor.
- Define quality goals for both annual and long range plans. Work with management and the department personnel to achieve goals and strategic initiatives.
- Conduct functional area management review; prepare appropriate metrics and present significant events to senior management.
- Define and execute goals and personnel development plans within the group. Provide annual performance reviews for direct reports. Recommend hiring, promotion and disciplinary action for staff.
- Bachelor's degree or equivalent experience is required; preferably in sciences, engineering or other technical/scientific area.
- 10+ years of experience in Quality Assurance or related GxP field including a thorough understanding of medical device development with knowledge of pharmaceutical processes and development principles. Expert knowledge of global medical device and combination product regulations.
- Key leadership competencies include engagement, visibility, relationship building, conflict resolution, cultural awareness, sound judgement and the ability to influence at all levels.
- Must have demonstrated ability to make critical, creative and strategic decisions as a result of rapid analysis of available information, including risk-assessment for the patient and for the business. Must be able to respond quickly to unplanned events and changing needs from development programs.
- Skilled in the selection, coordination and management of projects and have ability to resolve unusually complex technical problems by providing solutions that are highly innovative.
- Accreditation by a professional body is desirable (e.g. American Society for Quality (ASQ) Certified Quality Manager (CQM) and/or Certified Quality Auditor (CQA).
- Membership in professional organizations, e.g. Midwest Discussion Group, SQA and IQ Consortium, recommended for remaining current with peer organizations and providing opportunity to influence industry positions.