Associate Director, GMP Operational Quality - Cell & Genetic Therapies

Job DescriptionGeneral Summary:The Associate Director, GMP Operational Quality is responsible for oversight of team activities, development of personnel and ensuring quality of deliverables within department purview. The incumbent has comprehensive knowledge of principles and application of quality assurance and compliance. The incumbent is responsible for development of group goals and projects ensuring alignment with corporate goals and compliance with all regulatory requirements, refining goals and projects when necessary. The incumbent not only coordinates group responsibilities to ensure timely delivery to support business, but mentors team members to provide individual development in addition to efficient and valuable service to project teams.Key Duties and Responsibilities:Lead a Quality team: primarily responsible for providing quality oversight and support to business activities within purview at VertexCollaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutionsOversee CMO/Vendor performance, establishment of Quality Agreements and adherence of Quality Agreement termsEnable team to achieve team goals/objectives and enable their individual career developmentDevelop and maintain compliant quality processes to support GMP activitiesOversee the QA support of Change Controls, GMP investigations and associated CAPAs.Track performance metrics and report to Sr Management; develops tactics to improve performance outcomesParticipate in inspection readiness activities and lead Quality development discussions as necessary during regulatory site inspections.Support review of regulatory submissions, as applicableLead continuous improvements of department processes, realizing efficiency gains, and ensuring team continues to meet expanding business needs with lean resources.Lead and follow up on any QLT action items assigned.Identify and communicate risks and assist with risk mitigation plans as necessarySupports internal audit or external audit programs; assists in preparation of audit responsesProvide comprehensive knowledge support for partner and regulatory agency auditsAssist management team in budgeting and schedulingResponsible for the following activities related to people management responsibilities:Talent Acquisition/ Recruiting/Interviewing/ Selection/OnboardingPerformance Management (goals, monitoring, reviews);Monitoring /Supporting Employee Engagement and Retention;Succession Planning;Accomplishing staff results by communicating job expectations, planning, coaching, training and developing personal growth opportunities through IDPs.Accountable to provide oversight of day to day team operationsAssists with workforce planning/resource modeling and to update through forecasting activitiesKnowledge and Skills:In-depth and specialized knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and managing quality in support GMP manufacturingDemonstrated success in building high-performing teams and skilled at managing team and individual developmentStrong management skills with the ability to lead and motivate a team in a fast-paced environment while maintaining a high degree of quality, accuracy and timelinessSubstantial background in managing complex projects/teams within stated objectives and timelines and with a strong understanding of the underlying business drivers; skilled at applying project management processes / tools to lead meetings, assist with project planning, and facilitate attainment of project objectivesAbility to independently lead cross-functional teams and represent the interests, strategies and objectives of Quality unitStrong skills in mentoring staff and transferring technical knowledge to enable their capabilities and developmentAbility to communicate cross-functionally to a wide variety of audiences; exchanges complex concepts with the ability to influence leaders, customers, or vendors to adopt of a new point of view and/or to take actionDemonstrated ability to evaluate complex quality matters and make decisions utilizing risk-based approach; identifies and leverages the appropriate expertise to implement solutionsSubstantial experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPAExtensive exposure with multiple regulatory agencies across applicable GxPs during inspectionsSubstantial experience with electronic document management systems (e.g., QDocs, Trackwise, Veeva)Education and Experience:Bachelor's degree in a scientific or allied health field (or equivalent degree)Typically requires 8+ years of work experience and 2 years of management experience, or the equivalent combination of education and experienceAt Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.Pay Range:$156,600 - $234,800Disclosure 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 EligibleFlex 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 select2. 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-HybridCompany InformationVertex 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: Boston, MAType: Full time