The VP of Device Quality is responsible for managing all device related Quality activities at one or more Emergent sites, e.g., Baltimore Bayview, Baltimore Camden, Canton, Gaithersburg, Hattiesburg, Lansing, and Winnipeg.
Quality personnel serving the Device business unit (BU) at each site location(s) will have direct and/or indirect reporting to the Sr. Director of Device Quality. This position is responsible to craft and execute a product Quality strategy that supports Device product design and development, product approval, sustainable manufacturing and supply through in-house capabilities as well as third-party development and manufacturing partners.
The Head of Device Quality must exercise a comprehensive and contemporary understanding of drug device regulations and approval strategies. This role maintains a comprehensive and contemporary understanding of ISO/GxP for medical devices to support sustainably compliant and operationally excellent development and manufacturing of Device products.
The Sr. Director, Device Quality is responsible for all quality systems and the implementation of corporate policies and procedures at the specified site(s). He/She will ensure that internal processes and metrics are aligned to create a high level of product quality and consistency. He/She will substantially strengthen quality systems, determining the appropriate infrastructure and resources required to achieve business objectives at the site(s). The Sr. Director Quality is a key member of the Site Leadership Team. This role is responsible for helping to lead teams across site(s) in an integrated way that supports the delivery of business unit goals.
Quality responsibilities within the scope of this job include the following:
- Serve as a senior contributor on the Device business unit (BU) leadership team to define and drive BU objectives
- Provide leadership and drive strategic direction and objectives for the Quality functions at drug device development and manufacturing sites including
- Quality Assurance
- Quality Control
- GxP/ISO Compliance
- GxP/ISO Training
- Document Control
- Determine functional and headcount requirements to staff Quality functions strategically and prospectively
- Staff the organization to fulfill development and market distribution of products
- Ensure appropriate Quality support to CMO and component suppliers
- Promotes quality awareness and continuous improvement at the sites
- Provide support and oversight for clinical studies and premarket approval as required for marketing medical device products
- Promote Engineering and QBD standards within the Device BU network
- Provide device subject matter expertise for resolution of multi-variant problems
- Develop Quality management systems in conformance with ISO, FDA, and EU regulatory standards
- Provide Quality standards for product lifecycle management
- Serve as the Device representative on the Global Quality Leadership Team (GQLT)
- Maintain good application of compliance standards to enable excellent relationships with Regulatory agencies
- Partner with Development function to support early stage product development
- Represent Emergent in due diligence processes
- Build strong relationships with internal and external customers to build, enhance, and ensure quality awareness
- Develop and monitor appropriate metrics to track quality and process improvement
- Develop the required site processes and competencies to ensure that quality standards are implemented in accordance with corporate goals
- Ensures the proper interface of the quality function to product development, manufacturing, engineering/maintenance, and other areas as required
- Builds strong relationships with internal and external customers-to build, enhance and ensure quality awareness.
- Collaborates with all departments and functions to ensure that quality standards and ISO/GxP compliance are met and maintained.
- Develops and monitors appropriate metrics to track quality and process improvement.
- Develops the required site processes and competencies to ensure that quality standards are implemented in accordance with corporate goals.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
Education & Experience
The ideal candidate will have:
- BS degree in Engineering, Science, or Operations Management; Advanced Degree (s) preferred
- Familiarity with de novo and 510k regulatory strategies in winning approval or clearance to make and market medical device products
- Position requires a seasoned Quality Assurance professional with a minimum of 15 years of experience in device and biopharmaceutical/vaccine companies
- Must have a track record of success and a broad understanding of contemporary quality practices as they apply to product development/clinical manufacturing and commercial operations
- Has an excellent understanding of Quality requirements in both the US and EU
- Proven expertise in the design and implementation of quality processes in a world-class medical device/pharmaceutical/vaccine manufacturing organization
- Experience in development of an organizational culture that promotes and sustains quality as an element of superior business performance
- Must have technical competence and knowledge of drug/device product design, manufacturing, process design and improvement and act as an open and accessible resource to peers
- Must have a track record of success and a broad understanding of contemporary quality practices for medical device and combination product platforms
- Extensive relevant experienceapplying Quality risk management for drug device product development and manufacturing
- Experience in start-up of commercial operations. Bridging products from development to commercial stage
- Exceptional interpersonal skills with the ability to negotiate and resolve conflict with poise, tact and diplomacy
- Ability to effectively integrate the quality functions into the business as a whole
- Excellent verbal & written communication skills