Associate Director, GMP Operational Quality

Job Description General Summary: The Associate Director, GMP Operational Quality Assurance is a Quality leader and advanced technical resource responsible for strategic and operational Quality oversight across multiple complex programs. This role leads day-to-day quality operations, supports the execution of new initiatives, and applies sound judgment to resolve complex quality and compliance issues. The role provides Quality oversight for drug substance disposition from development through process performance qualification, ensuring decisions align with patient safety, product quality, regulatory expectations, and business continuity. This role serves as a visible Quality partner to Product Quality Leads, MSAT, Regulatory Affairs, operational stakeholders, CDMOs, and suppliers. The successful candidate will be a key member of the Vertex Biologics and Devices Quality Team, influencing cross-functional alignment, proactively managing risk, and providing timely quality direction in support of external drug substance manufacturing and disposition. Key Duties and Responsibilities: Lead cross-functional collaboration with Manufacturing, Quality Control, MSAT, Regulatory Affairs, and other Quality functions to resolve complex deviations and align decisions with patient safety, product quality, and regulatory compliance Represent Quality on cross-functional teams as a senior technical resource and decision-maker Lead drafting, negotiation, and oversight of Quality Agreements with CDMOs, suppliers, and Vertex, as needed Provide Quality oversight and direction to Change Control owners to ensure compliance with procedural and regulatory expectations Initiate, assess, and approve change controls, as appropriate, using risk-based decision-making Provide Quality leadership and technical expertise for deviation investigations, including OOS/OOT events, by ensuring robust root cause analysis and timely, effective CAPA implementation Review and approve complex investigations and CAPAs to ensure scientific rigor, compliance, and sustainable corrective actions Review and approve master and executed batch records to support external drug substance disposition activities Analyze Quality Metrics and performance trends to identify risks, drive continuous improvement, and inform Quality leadership decisions Develop and recommend strategies to address compliance gaps and strengthen cross-functional quality systems Lead or contribute to operational review and escalation meetings to ensure Quality issues are appropriately prioritized, assessed, escalated, and resolved for external drug substance manufacturing operations Drive completion of assigned QLT action items by coordinating stakeholders, clarifying expectations, and ensuring timely follow-through Proactively identify, assess, communicate, and mitigate quality and compliance risks across assigned programs and external manufacturing activities Provide technical Quality guidance during partner and regulatory agency audits Review regulatory submissions, as needed, to ensure technical accuracy, clarity, and alignment with current regulatory expectations Drive Quality readiness for major development milestones including IND/IMPD submissions, clinical supply manufacturing, PPQ, and regulatory inspections Ensure quality risks are proactively identified and escalated within program governance Knowledge and Skills: In-depth knowledge of cGMP principles and their practical application in a biologics pharmaceutical setting, including global GMP manufacturing requirements Demonstrated leadership and influence across matrixed teams, with the ability to set direction, drive accountability, and deliver quality outcomes in a fast-paced environment Experience leading complex quality initiatives with contract manufacturing organizations, including cross-functional planning, issue escalation, stakeholder alignment, and continuous improvement Advanced experience identifying, assessing, communicating, and mitigating quality and compliance risks using quality risk management principles and sound business judgment Ability to mentor and coach less experienced colleagues, build technical capability, and model effective quality decision-making Excellent communication and influencing skills, including the ability to translate complex and sensitive quality issues into clear recommendations for cross-functional and external audiences Demonstrated ability to operate independently, exercise sound judgment, and provide quality leadership for large, multifaceted projects Demonstrated ability to evaluate complex quality matters, make risk-based decisions, synthesize diverse information, and shape practical solutions Experience leading complex event investigations, root cause analysis, CAPA strategy, and effectiveness assessments Experience with electronic document management systems, such as QDocs, TrackWise, and Veeva Education and Experience: Bachelor's degree in a scientific or allied health field (or equivalent degree) Typically requires 8+ years of relevant GMP Quality experience, including leadership of complex quality initiatives and QA oversight of external manufacturing operations Pay Range: $94,600 - $141,800 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.