Medical Device Quality Manager

Job description

Responsible for quality of assigned 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. Primary products include breast implants, ocular implants, consumer eyecare products, dermal fillers, infusion pumps and enteral tubing. Products may be produced by AbbVie plants or by third-party manufacturers, in licensing relationships, or co-marketing relationships. Collaborates to develop the appropriate regulatory strategies for product brands in concert with Regulatory Affairs. Ensures delivery of quality elements needed to facilitate on-market support for the combination products and medical devices. Supports Global Product Quality Assurance strategy and implements agreed strategy to support the products at AbbVie plants. Makes key decisions on product quality, compliance and regulatory conformance issues for medical devices and combination products and ensures risk-based elevations to AbbVie leadership. Leads 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 linking this to local/global project implementation. Leads a team of SMEs and provides an 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 product transfers, on-market support and organization optimization. Participates in the development of global Product Quality Assurance strategy to support device and combination products produced at AbbVie plants as well as contract manufacturing and supplier facilities. Implements agreed strategy. 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 AbbVie with the agreed service. Prioritizes programs, initiatives, and problem solving with consideration for impact to timelines, resources and conflicting priorities. Interfaces 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. Provides support for quality audits, initial site approvals and due diligence activities. Leads and manages pre-approval inspection readiness as related to contract manufacturers to ensure regulatory approvals are obtained, with no delays to market entries. Participates and leads product quality investigations to identify root cause and implement corrective actions. Coordinates activities to support follow-up on complaint trend investigations for non-medical and medical (adverse events). Supports the management of exception documents and Corrective and Preventive Actions. Collaborates 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 relevant Life Science or other technical 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 7+ in Quality Assurance Operations Management, Regulatory, Operations, or Technical Support. 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 are 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. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​ The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​ We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​ This job is eligible to participate in our long-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​ 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: About AbbVie AbbVie'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 - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.