Aseptic Product Quality Manager

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. 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 Manufacturers (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, and will promote improvements that proactively identify, quantify, prioritize, and mitigate aseptic risks. The Global Quality Manager will also establish collaborative relationships with AbbVie’s internal sites, the aseptic global team, and cross‑functional teams. Maintains the primary quality lead with management oversight for project activities and the team members to achieve on‑time quality deliverables, high customer value, and profitable results. Provides Eye Care Quality Assurance TPM team support for investigation of aseptic events by providing hands‑on assessments and investigation support. Drives implementation and aseptic best practices at TPM based on AbbVie’s standards and technological advancements. Performs final quality release of manufactured product lots for products and/or product lines prepared by Third Party Manufacturers. Makes recommendations for key decisions on product quality and compliance and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products and elevates medium and high risk events to AbbVie management. 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, AbbVie plants, affiliates and other functional groups. 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. 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. Contributes to Quality Assurance elements needed to facilitate new product launches, coordinates activities to support follow‑up on compliant trend investigations, supports the management of exception documents and Corrective and Preventive Actions. Completes management reviews with assigned Third Party Manufacturers that identify and address quality, operational, and organizational issues. Qualifications Bachelor’s Degree in a relevant Life Science or other technical discipline or equivalent job experience. 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. Ability 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, members and individuals. Compensation & Benefits Compensation range is a 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. Package of benefits includes paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. Eligibility to participate in 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 unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. Equal Opportunity Employer 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. EEO Information US & Puerto Rico only – to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: #J-18808-Ljbffr AbbVie