Job Description General/Position Summary The Associate Director – Shift Quality Operations is an advanced technical resource in the principles and application of quality assurance and compliance. The Associate Director provides quality leadership and oversight for manufacturing operations conducted across assigned shifts for cell therapy manufacturing. This role is responsible for ensuring ongoing compliance with cGMP, aseptic processing requirements, site quality systems, and regulatory expectations while enabling safe, reliable, and efficient manufacturing. The position partners closely with Manufacturing, Quality Assurance, Quality Control, MSAT, Engineering, Validation, and Supply Chain to support batch execution, deviation management, investigations, line clearance, contamination control, and continuous improvement. The Associate Director also leads and develops a team of quality professionals providing real-time shop floor quality oversight. This On-Site role is located at Vertex’s VMC Key
Duties
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Responsibilities
Quality Oversight Provide shift-based QA oversight for aseptic manufacturing operations, including formulation, filling, inspection, and supporting activities as applicable. Ensure manufacturing activities are executed in compliance with cGMP, GDP, site procedures, and aseptic processing standards. Serve as the primary quality representative for escalating critical quality issues appropriately. Support batch disposition readiness through review of manufacturing documentation, events, and quality observations. Demonstrated understanding of digital quality systems, data management, automation, and emerging AI technologies within regulated GxP environments. Responsible for using platforms such as MES, LIMS, eQMS, data visualization tools, and advanced analytics to perform Quality oversight. Aseptic Operations Support Oversee quality execution for critical aseptic operations, material flow and contamination control practices, line clearance, and cell therapy manufacturing including chain of custody and identity. Ensure adherence to Contamination Control Strategy (CCS) and aseptic behaviors on the manufacturing floor. Provide real-time decision-making support during quality events and atypical situations. Deviation, Investigation, and CAPA Management Lead or support deviation triage, investigation, root cause analysis, impact assessments, and CAPA development. Ensure quality issues are documented, investigated, and closed in a timely and compliant manner. Identify recurring issues and drive sustainable improvements to prevent repeat events. Expertise in utilizing eQMS platforms for QMS activities. Team Leadership Lead, coach, and develop a team of shift quality professionals. Establish clear goals, performance expectations, and development plans. Promote a culture of quality, accountability, inspection readiness, and continuous improvement. Ensure adequate shift coverage and effective handoff across shifts. Inspection Readiness and Compliance Maintain a constant state of inspection readiness for aseptic manufacturing areas. Support internal audits, regulatory inspections, and client audits. Ensure observations are addressed promptly and effectively. Cross-Functional Collaboration Partner with site leadership and cross-functional teams to support: Production schedule adherence Product quality Operational excellence Tech transfer/startup activities Process improvements Act as a trusted advisor on quality risk and compliance decisions. Required
Education
Level Bachelor’s degree in Biology, Microbiology, Chemistry, Pharmaceutical Sciences, Engineering, or related discipline required. Preferred master’s degree or relevant comparable background. Required
Experience
8+ years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment. 5+ years of experience supporting aseptic manufacturing, sterile operations, or parenteral production. Prior people leadership or supervisory experience strongly preferred.
Experience
with shop floor QA oversight in a commercial or late-stage clinical manufacturing environment preferred. Required Knowledge/Skills Strong knowledge of: cGMP regulations Aseptic processing principles Annex 1, FDA sterile manufacturing expectations, and contamination control concepts Deviation/CAPA/investigation systems Batch record review Risk management and quality systems Ability to assess quality risk in real time and make sound compliance-based decisions. Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma. Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence. Critical Thinking and Problem Solving skills Other
Requirements
Up to 5% travel
Pay Range
$153,900 - $230,900 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: On-Site Designated Flex Eligibility Status: In this On-Site designated role, you will 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-Onsite 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 ApplicationAssistance@vrtx.com 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 www.vrtx.com 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.