GMP Operational Quality Senior Manager

Key Responsibilities Collaborate with internal and external business partners to resolve complex quality issues ensuring compliant solutions. Participate in cross‑functional teams as an experienced Quality technical resource. Draft and enforce Quality Agreements between CMOs/Suppliers and Vertex as needed. Assist Change Control owners with ensuring compliance to 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. Ensure CAPA actions are identified and addressed; approve investigations and CAPAs. Lead continuous improvement efforts. Maintain Quality Metrics to support process improvement activities. Provide tactics to address compliance gaps and recommend enhancements to cross‑functional quality systems. Conduct GMP document review (procedures, work instructions, specifications, methods, protocols, method reports). Coordinate and follow up on QLT action items. Identify and communicate risks, assist with risk mitigation plans. Support internal and external audit programs; assist in audit responses. Manage audit CAPAs & metrics. Provide technical advice for partner and regulatory agency audits. Assist in budgeting and scheduling. Knowledge and Skills In‑depth knowledge of cGMPs in a pharmaceutical setting and global GMP requirements. Strong team leadership and project management skills in a fast‑paced environment. Experience leading complex projects and continuous improvement initiatives. Ability to lead cross‑functional teams and represent the Quality unit. Mentoring and knowledge transfer to less experienced colleagues. Excellent cross‑functional communication and influence. Independently provide QA advice for large, multifaceted projects. Evaluate quality matters and make complex decisions using advanced judgment. Experienced in event investigations, RCA, and CAPA. Experience with electronic document management systems (QDoccs, Trackwise, Veeva). Education and Experience Bachelor’s degree in a scientific or allied health field (or equivalent). Typically requires 6 years of experience, or equivalent combination of education and experience. Pay Range $136,400 - $204,600. Eligible for annual bonus and equity awards; overtime pay in accordance with federal and state requirements. Flex Designation Hybrid‑Eligible or On‑Site Eligible. Hybrid: remote up to two days per week; On‑Site: five days per week with ad hoc flexibility. EEO Statement Vertex is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E‑Verify Employer. Vertex will make reasonable accommodations for qualified individuals with known disabilities. Anyone requiring an accommodation in the hiring process should contact View email address on click.appcast.io. #J-18808-Ljbffr Vertex Pharmaceuticals Inc (US)