Laboratory Manager, Product Development QA

Job description

This Hybrid role could be based in any of these AbbVie locations: North Chicago, IL Cambridge, MA, Irvine, CA, San Francisco, CA Purpose: Primarily responsible for leading Product Development QA from an analytical perspective in support of clinical supply release. Responsibilities: • Support CMC teams in resolving complex technical Analytical challenges through various phases • of development • Provide leadership and daily support to the Lab QA team • Drive continuous process improvement within Product Development QA by • updating/authoring policies/processes/procedures and related documents • Lead QA Analytical audit /inspection preparation activities and support the • audits/inspections as the QA SME • Develop, maintain, and report key quality metrics to Management • Lead for analytical testing batch release; coordination and issue resolution • Review and approval of excipient, drug substance and product specifications, including • justification and revisions • Write/review/approve exception reports, including high impact and complex ERs • impacting multifunctional areas • Approve Laboratory investigations • Responsible for assessing compliance to regulations and industry practice and • implementing applicable process changes • Bachelor's degree or equivalent experience is required; typically, in life sciences or • engineering. Master’s degree is preferred but is not required based on commensurate • experience. • 6-8 years of experience in function or related field, preferably with quality assurance • and/or analytical sciences, or a combination thereof • Strong understanding of Active Pharmaceutical Ingredients (API) and drug product GMP • manufacturing as applied to laboratory operations is preferred, as well as an • understanding of Quality Assurance principles and systems. • Strong understanding of US and international regulations for quality systems and • compliance, as applicable to investigational products • Experience in project management, coordination, and planning of complex activities • Ability to take a collaborative and risk-based approach to problem solving • Effective use of oral and written communication skills to clearly communicate the • quality position, and the actions necessary to resolve issues • Capable of clearly presenting and justifying quality requirements throughout all levels of • management 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 www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.