Senior Manager, Operational Area Quality (Combination Products)

Job Description General Summary The Operational Area Quality Senior Manager provides quality leadership for assembly manufacturing operations supporting medical device and combination products. The role is responsible for quality oversight of manufacturing operations, product disposition, batch record review, deviations, investigations, CAPAs, change controls, supplier quality, and regulatory compliance while partnering with manufacturing, engineering, supply chain, and external manufacturing partners. The position also supports design quality activities to ensure manufacturing changes remain aligned with design control and risk management requirements throughout the product lifecycle. ⸻ Key Duties and Responsibilities - Lead Quality Assurance support for assembly manufacturing operations of medical device and combination products, ensuring compliance with GMP, regulatory requirements, and internal quality systems. - Provide quality oversight for product disposition activities, including review and approval of manufacturing documentation to support timely release of clinical and commercial product. - Review and approve Manufacturing Batch Records (MBRs), Electronic Batch Records (EBRs), Device History Records (DHRs), and associated manufacturing documentation. - Lead and approve manufacturing deviations, investigations, nonconforming material reports (NCMRs), CAPAs, change controls, and effectiveness checks. - Conduct and lead root cause investigations using structured problem-solving methodologies and ensure implementation of effective corrective and preventive actions. - Support manufacturing operations by providing real-time quality oversight for assembly processes, equipment issues, process improvements, and manufacturing investigations. - Partner with Contract Manufacturing Organizations (CMOs) to ensure compliance with Quality Agreements, disposition requirements, manufacturing investigations, and continuous improvement initiatives. - Support manufacturing process validation, equipment qualification, technology transfers, and process improvements to ensure products remain in a validated state. - Lead supplier quality activities including supplier investigations, supplier change assessments, supplier qualification, and quality issue resolution. - Support regulatory inspections, customer audits, supplier audits, and internal audits while ensuring timely responses and closure of observations. - Support complaint investigations and product quality assessments as required. - Support Design Quality activities by reviewing design changes, participating in design reviews, supporting Design History File maintenance, and ensuring manufacturing changes are appropriately evaluated through design controls and risk management. - Provide input into risk management activities, including DFMEA, PFMEA, hazard analyses, and Risk Management Files, to ensure manufacturing risks are appropriately evaluated throughout the product lifecycle. - Promote continuous improvement initiatives to enhance manufacturing quality, compliance, operational efficiency, and product reliability. ⸻ Knowledge and Skills - Strong experience supporting assembly manufacturing operations for medical devices and combination products. - Demonstrated experience reviewing and approving MBRs, EBRs, DHRs, product disposition, manufacturing investigations, CAPAs, deviations, change controls, and nonconforming material records. - Strong knowledge of autoinjector and drug-device combination products, including assembly processes, manufacturing operations, supplier management, and product lifecycle support. - Demonstrated knowledge of GMP, 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and applicable combination product regulations. Experience supporting process validation, equipment qualification, technology transfers, and manufacturing readiness. - Experience working with Contract Manufacturing Organizations (CMOs) and external suppliers. - Working knowledge of Design Controls and Risk Management to support manufacturing quality activities and lifecycle changes. - Strong technical problem-solving, investigation, and root cause analysis skills. - Excellent leadership, communication, and cross-functional collaboration skills. - Experience with statistical analysis tools, Minitab, and quality engineering methodologies preferred. ⸻ Education and Experience - Bachelor’s degree in Engineering, Life Sciences, Quality, Manufacturing, or a related technical discipline is required. Advanced degree preferred. Typically requires 10+ years of Quality Assurance, Quality Engineering, Manufacturing Quality, or Operations Quality experience within the medical device, biotechnology, pharmaceutical, or combination product industry. - Minimum of 5 years supporting GMP manufacturing operations, including assembly manufacturing, product disposition, deviation management, investigations, CAPA, change control, and batch record review. - Demonstrated experience supporting autoinjector, prefilled syringe, or other drug-device combination products from clinical through commercial manufacturing. - Experience leading cross-functional quality initiatives and partnering with Contract Manufacturing Organizations (CMOs) and suppliers. - Prior people leadership or demonstrated technical leadership of complex quality programs is preferred Pay Range: $133,800 - $200,600 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's 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 in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at View email address on click.appcast.io Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.