Program Manager III
KellyMitchell matches the best IT and business talent with premier organizations nationwide. Our clients, ranging from Fortune 500 corporations to rapidly growing high-tech companies, are exceptionally served by our 1500+ IT and business consultants. Our industry is growing rapidly, and now is a great time to launch your career with the KellyMitchell team.
Core Team member on a Medical Device development project from feasibility through market launch. Important knowledge and experience includes:
• Device Design Control
• Infusion Pumps – Technical or Quality Experience
• Supplier Management and Quality Oversight
• Ideal candidate will have a combination of technical and quality experience.
Core Team member developing an infusion pump system to administer a finished drug product. Devices may be manufactured either internally or by third-party manufacturers. Acts as the primary quality representative for the global supply chain. Candidate will build and maintain relationships with TPM Operations, Supplier Quality Management, TPM Business Alliance, Commercial, Global Supply Chain, Domestic and International Plants and Affiliates, Regulatory Affairs, R&D, and S&T to ensure alignment on strategic direction, and execution of project deliverables.
• Represent Quality on the project core team for product transfer activities and direct cross-functional team members to achieve on-time quality deliverables, high customer value, and profitable results. Ensures delivery of all quality elements needed to facilitate new product launches including Third Party Manufacturer’s that provide products directly to distribution centers, or to domestic and International plants for further packaging and/or testing. Primary driver for the quality and compliance.
• Develops Global Product Quality Assurance strategy and implements agreed strategy to support device and combination products produced at plants as well as third party manufacturing (TPM) facilities.
• Primary Quality contact between third party manufacturers, R&D and Operations in support of commercial operations, New Product Introductions and product transfers. Supports the regulatory filings and marketing authorization dossiers.
• Makes key decisions on product quality, compliance and regulatory conformance issues for device products and elevates medium and high risk events to management. Leads the collection, verification and improvement of Quality metrics used for management review in partnership with senior leadership to develop a clear picture of overall compliance state and linking this to local / global project implementation.
• Leads product quality team to support development of the legal supply agreements, contractors or letters of intent to ensure that the appropriate quality, compliance and regulatory aspects are met for the products and services covered and manage the organization’s actions within the legal boundaries of these documents. Ensures alignment of Quality and Technical Agreements with the legal contracts and that the commitments of the quality and technical agreements are being fulfilled.
• Establishes and maintains relationships and open communication with Third Party Manufacturers, plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at each site and provide guidance on quality concerns. Supports the management of exception documents and CAPA.
• Communicates and negotiates with external companies’ quality organization to maintain a consistent level of quality and a level of expectation that will minimize compliance risks but also balance the cost of operating to provide the client with the agreed service. Prioritizes programs, initiatives, and problem solving with consideration for impact to timelines, resources and conflicting priorities.
• Manages team interfaces with Quality Assurance audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable. Provides support for quality audits, initial site approvals and due diligence activities. Leads and manages pre-approval inspection readiness as related to the third party manufacturers to ensure regulatory approvals are obtained, with no delays to market entries.
• Bachelor’s Degree in relevant Engineering or other technical degree required. Graduate degree desired. Technical or Analytical background required for problem resolution with technical, quality, product and or engineering related issues.
• Total combined years of experience. Minimum of 10+ in Quality Assurance Operations Management, Regulatory, Operations, or Technical Support in a device setting. Required regulatory inspection experience with direct interaction with regulatory inspectors.
• Possesses knowledge and a skill set to operate within an environment that requires a high degree of urgency, strong analytical and problem solving skills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as leaders, team members and individuals.
• Strong quality assurance / control, manufacturing, laboratory, technical support, regulatory, and / or validation background is required.
• A wide range of activities will be undertaken from long term strategy development to short term crisis management. The incumbent must be capable of understanding and overcoming differing cultural and language obstacles to provide solutions that satisfy Corporate, Divisional, regional, and local objectives to effectively manage the action plans that will resolve the issues.
• Experience working the requirements for third party external manufacturing.