Senior Product Quality Manager (Peptide Technology)

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 Job Description Responsible for quality of assigned new product introduction programs to ensure business objectives are met with regard to on‑time deliverables of program development while assuring compliance with local, divisional, and corporate policies and external agency regulations worldwide. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), and Drug Products produced by AbbVie plants or by third‑party manufacturers, in licensing relationships, or co‑marketing relationships. Develop in concert with the appropriate regulatory strategies set forth by the governance processes. AbbVie Operations Quality Assurance is seeking a Product Quality Manager to lead quality deliverables for late‑stage development and commercialization of Peptides, from registration through commercialization. We are seeking a highly motivated candidate with a proven track record of accomplishment in the field of peptide manufacturing development, to work in a multi‑functional team environment at our North Chicago, IL location. Leads the development and implementation of global Product Quality Assurance strategy to support New Product Introduction (NPI) programs for the end‑to‑end commercial supply chain both at AbbVie plants as well as contract manufacturing facilities. Drives implementation of the Product Transfer Process. Primary driver for product quality risk management and compliance aspects of product development. Acts as global quality lead to support regulatory submission by developing, reviewing and approving relevant module 3 documents. Works with Regulatory Affairs and coordinates with GMP manufacturing sites to prepare submissions and provides responses to agency submission deficiencies/questions in a timely manner. Leads and manages pre‑approval inspection readiness for the NPI programs. Ensures regulatory approvals are obtained with no delays to market entries. Leads the selection of external manufacturing partners from Quality for NPI programs. Leads the quality partner assessment and up‑skilling of the partners to meet AbbVie Operations expectation. Partners with Quality Assurance audit team to qualify external manufacturing partners. Communicates and negotiates with external manufacturing partner quality organization to maintain a consistent level of quality. Provides quality oversight to maintain partner qualification for development and commercialization. Supports the management of exception documents and Corrective and Preventive Actions. Coordinates input from technical groups to determine root cause and implement appropriate actions. Serves as global quality representative at the change review board to drive/support global change plans needed for NPI programs. Establishes and maintains relationships and open communication with cross‑functional groups to maintain roles and responsibilities and provides guidance on quality concerns. Drives continuous improvement for NPI programs. Qualifications Bachelor’s Degree in a relevant science field required. Minimum 8+ years of total combined experience. At least 3 years in Quality Assurance Operations Management; 5+ years in any of the following areas: Operations, Research and Development, Regulatory. Direct Manufacturing Plant experience in a pharmaceutical setting is preferred. Comprehensive understanding of pharmaceutical technologies, specifically peptide technology, is required. Experience in pharmaceutical development and commercialization is preferred. Strong quality assurance/control background is required. Experience with FDA and other regulatory agency interactions and inspections is required. Interacts well with diverse groups within function and maintains strong working relationships with internal and external collaborators. 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 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. Equal Opportunity and Accommodations 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