GMP Operational Quality Manager

Key Responsibilities Participate in cross-functional teams as a Quality technical resource, providing quality oversight and support to analytical testing at contracted suppliers. Draft and enforce Quality Agreements between CMOs/Suppliers and Vertex. Assist Change Control owners to ensure compliance with change procedure requirements; assess and approve change controls. Conduct quality investigations/deviations; review corrective action plans for adequacy and compliance, including root cause analysis and product impact assessments for deviations and OOS. Ensure appropriate CAPA actions are identified and addressed; approve investigations/CAPAs. Identify, facilitate, and/or lead continuous improvement efforts. Maintain Quality Metrics to support process improvement. Conduct GMP document review (procedures, work instructions, specifications, methods, protocols, and method reports). Perform disposition activities for Commercial products. Coordinate, facilitate, and follow up on QLT action items. Identify and communicate risks and assist with risk mitigation plans. Support internal/external audit programs; assist with audit responses. Manage audit CAPAs and metrics; provide technical advice for partner/regulatory agency audits. Minimum Qualifications (Knowledge and Skills) In-depth knowledge of cGMPs and global GMP requirements for pharmaceutical manufacturing and analytical lab testing. Strong leadership; able to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives. Experience leading complex projects/teams and continuous improvement; applies project management tools to facilitate planning and task completion. Ability to independently lead cross-functional teams and represent the Quality unit. Ability to mentor/guide staff; transfer technical knowledge. Strong cross-functional communication and influence. Ability to evaluate quality matters and make complex decisions using technical experience and advanced judgment. Strong experience with investigations, RCA, and CAPA. Experience with electronic document management systems (e.g., Veeva). Education and Experience Bachelor’s degree in a scientific or allied health field with 5+ years relevant experience (or equivalent). Experience providing Quality oversight of GMP manufacturing, including batch disposition. Experience with drug substance, spray dried dispersion (SDD), and drug product development/manufacturing (oral solid dosage forms preferred). Knowledge of cGMP requirements governing oral drug products manufacturing practices. #J-18808-Ljbffr Scorpion Therapeutics