Associate Director, Design Quality - Late Stage Development

Job Description 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 AbbVie plants or by third‑party manufacturers, in licensing relationships, or co‑marketing relationships. Develop the appropriate Regulatory, Quality, and Product Development strategies for NPI products in concert with Regulatory Affairs, Marketing, Product Development and other cross‑functional stakeholders. Act as the primary quality representative and manage a team of product subject matter experts (SMEs). Responsibilities 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 AbbVie 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. Provide oversight for project activities and the team members (within and outside of AbbVie) 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 while balancing cost of operating to provide AbbVie with the agreed service. Prioritize programs, initiatives, and problem solving with consideration for impact to timelines, resources, and conflicting priorities. Interface with AbbVie’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 to provide feedback on product quality for management reviews with assigned contract manufacturers that identify and address quality, operational, and organizational issues. Qualifications Bachelor’s Degree in 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 of 10+ years combined experience in Quality Assurance Operations Management, Regulatory, Operations, or Technical Support in a pharmaceutical setting. Required regulatory inspection experience with direct interaction with regulatory inspectors. Direct plant experience in a pharmaceutical setting with a minimum of 5 years preferred. Knowledge and comprehensive understanding of biological and/or pharmaceutical technologies such as sterile, biological, liquid, ointments, devices, solid tablets and caplets, suspensions, granulations, soft elastic capsules, gel caps, extended release products, coating solutions, and/or active pharmaceutical ingredients. Strong analytical, problem‑solving, interpersonal, and multi‑tasking skills; capable of performing as leader, team member, and individual. Strong quality assurance/control, manufacturing, laboratory, technical support, regulatory, and/or validation background required. Ability to understand and overcome differing cultural and language obstacles to provide solutions that satisfy corporate, divisional, regional, and local objectives. Experience working with third‑party external manufacturing requirements. Benefits Competitive base pay range (subject to geographic location and other factors). Compensation may be modified in the future. Comprehensive benefits package including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees. Eligible to participate in long‑term incentive programs. Equal Opportunity Statement AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled. US & Puerto Rico only – to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: #J-18808-Ljbffr BioSpace