Aseptic Product Quality Manager

Company Description 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 Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description The Aseptic Product Quality Manager acts as a quality SME for aseptic manufacturing within the External Product Quality Assurance Eye Care Global Team. The position is responsible for supporting aseptic events within the Eye Care Quality Assurance Third Party Manufactures (TPM) team by providing hands‑on assessments and investigation support. The Global Quality Manager will drive implementation and aseptic best practices at TPM based on AbbVie’s standards and technological advancements. The Global Quality Manager will work effectively with TPM by promoting improvements that proactively identify, quantify, prioritize, and mitigate aseptic risks. The Global Quality Manager will also establish collaborative relationships with AbbVie’s internal sites, aseptic global team, and cross‑functional teams. Maintain the primary quality lead with management 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 and organization optimization. Provide Eye Care Quality Assurance Third Party Manufactures team support for investigation for aseptic events by providing hands‑on assessments and investigation support. Drive implementation and aseptic best practices at TPM based on AbbVie’s standards and technological advancements. Perform final quality release of manufactured product lots for products and/or product lines prepared by Third Party Manufacturers. Make recommendations for key decisions on product quality and compliance and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products and elevate medium and high risk events to AbbVie management. Ensure alignment of Quality and Technical Agreements with legal contracts and that the commitments of the quality and technical agreements are being fulfilled. Establish and maintain relationships and open communication with Third Party Manufacturers, AbbVie 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. 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 AbbVie with the agreed service. Prioritize programs, initiatives, and problem solving with consideration for impact to timelines, resources, and conflicting priorities. Interface with Quality Assurance audit team to develop audit plans, due diligence plans, and inspection readiness plans; review audit observations and responses; 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 the third‑party manufacturers to ensure regulatory approvals are obtained, with no delays to market entries. Contribute to Quality Assurance elements needed to facilitate new product launches including Third Party Manufacturers that provide products directly to distribution centers, or to AbbVie domestic and international plants for further packaging and/or testing. Coordinate activities to support follow‑up on compliant trend investigations for non‑medical and medical (adverse events). Support the management of exception documents and Corrective and Preventive Actions. Complete management reviews with assigned Third Party Manufacturers that identify and address quality, operational, and organizational issues. Obtain and review summaries of the Annual Product Reviews (domestic) and Annual Product Quality Reports (EU) from the Third Party Manufacturer to ensure accuracy, completeness, timeliness, and trends are identified and addressed in an appropriate manner. Role can be worked from any AbbVie site globally Qualifications Bachelor’s Degree in a relevant Life Science or other technical discipline or equivalent job experience required. 7+ years of total combined experience. At least 5 years in Quality Assurance/Aseptic Manufacturing Operations Management; 3 years in Operations, Research and Development or Consulting. Knowledge and comprehensive understanding of aseptic manufacturing and some biological and/or pharmaceutical technologies (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). 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 a leader, member and individual. Additional Information 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 short‑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 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: #J-18808-Ljbffr Allergan