Senior Director, Design Quality NPI Medical Devices

About Abb Vie

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology, and neuroscience, as well as products and services in our Allergan Aesthetics portfolio.

Responsible for the quality of assigned New Product Introduction (NPI) combination products and medical devices to ensure business objectives are met with regards to on‑time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include on‑body delivery systems, pre‑filled syringes, auto‑injectors, infusion pumps, enteral and sub‑cutaneous tubing, pump‑carrying accessories, and other drug administration system accessories.

Products may be produced by Abb Vie plants or by third‑party manufacturers in licensing relationships, or co‑marketing relationships. Develop appropriate Regulatory, Quality, and Product Development strategies for NPI products in concert with Regulatory Affairs, Marketing, Product Development, and other cross‑functional stakeholders. Acts as the primary quality representative and manages a team of product subject matter experts (SMEs).

• Lead a team of Quality Professionals responsible for managing Design Control activities for NPI projects and direct cross‑functional team members to achieve on‑time quality deliverables, high customer value, and profitable results.
• Ensure delivery of all quality elements needed to facilitate new product introductions of combination products and medical devices.
• Develop global Product Quality Assurance strategy and implement agreed strategy to support the development of NPI projects.
• Make key decisions on product quality, compliance and regulatory conformance issues for medical devices and combination products and ensure risk‑based elevations to Abb Vie leadership.
• Lead the collection, verification and improvement of quality metrics for management review in partnership with senior leadership to develop a clear picture of overall compliance state and link this to local/global project implementation.
• Lead a team of SMEs and provide oversight for project activities and the team members (within and outside of Abb Vie) to achieve on‑time quality deliverables, high customer value, and profitable results. Primary driver for the quality and compliance aspects of NPI projects.
• Participate in the development of global Quality Assurance strategy for NPI projects to support development of device and combination products. Implement agreed strategy.
• Communicate and negotiate 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 Abb Vie with the agreed service. Prioritize programs, initiatives, and problem solving with consideration for impact to timelines, resources and conflicting priorities.
• Interface with Abb Vie’s audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable. Provide support for quality audits, initial site approvals and due diligence activities. Lead and manage pre‑approval inspection readiness as related to contract manufacturers to ensure regulatory approvals are obtained, with no delays to market entries.
• Collaborate with internal and external partners in providing feedback on product quality for management reviews with assigned contract manufacturers that identify and address quality, operational, and organizational issues.

• Bachelor’s Degree in a relevant Life Science or other technical field required. Graduate degree desired. Technical or Analytical background required for problem resolution with technical, quality, product and or engineering related issues.
• Minimum 10+ years combined experience in Quality Assurance Operations Management, Regulatory, Operations, or…