Director, GMP Operational Quality Cell and Gene (On-site)

Job DescriptionGeneral Summary:The Director GMP Quality Operations is responsible for the quality oversight of operations of the manufacturing site for the manufacture of Cell Product, including management of direct reports and defining daily priorities to execute the team's responsibilities. The role is responsible for Quality oversight on the manufacturing floor and product disposition of clinical and commercial drug product.The role will lead initiatives and participate in cross-functional project teams for the development of Cell & Genetic Therapeutic Programs as well with the roadmap to transforming to a commercial level operation.Key Duties and Responsibilities:Responsible for Quality oversight of Vertex Cell and Gene Therapy manufacturing internal operations across all phases of development and commercial, support of analytical laboratory, materials management, and facility/engineering groups.Collaborate with internal business partners to prioritize and resolve complex quality issues, product quality impact assessments and identify compliant solutionsResponsible for GMP batch disposition activities including review and approval of batch records, deviations, in-process data, EM data, QC release testing, materials review board and other quality activities as applicable to determine acceptability of product disposition.Provide QA oversight of change controls, process and OOS investigations, and associated CAPAs.Review and approval of manufacturing documents such as technical and analytical protocols/reportsSupport GMP release of incoming raw material and components.Responsible for timely identification of compliance risks and gaps for GMP processes, and implementing mitigating controls.Lead audit and inspection readiness activities.Lead timely and thorough audit response activitiesAssist with addressing product complaintsMaintain monthly metrics to determine and share the health of the businessAssists department with routine/quarterly Quality System data review metrics and reportingLead and participate in Cell & Genetic Program and Quality projects and drive continuous improvement activities.Provides information to assist in budgeting, scheduling, project planning within GMP Operational QualityProvides routine and/or requested business and culture updates to leadershipResponsible for the culture of the Quality team; facilitates team meetings, 1:1 meetings, skip level meetings, and takes appropriate action as applicableWork effectively and efficiently in a fast-paced environmentManages team workload and priorities to ensure tasks are completedDevelops and maintains an organization business continuity planKnowledge and Skills:In-depth knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; Biotec/Cell & Gene GMP regulations and applicability. (e.g. FDA, ICH, USP, etc. or other industry best practices ex. ISPE, WHO, etc.)Demonstrated experience working in a manufacturing site, managing operations/ QA Operations and oversight of GMP manufacturing operations.Change agent, influencing skills and ability to work in a fast paced dynamic environment.Experience with network-based applications such as Oracle, TrackWise, VeevaUnderstanding of regulatory environment including quality systems and compliance.Knowledge of aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing.Ability to evaluate quality matters and make decisions utilizing risk-based approachCritical Thinking and Problem Solving skillsAbility to independently lead cross-functional teams, and effectively communicate with business stakeholders.In-depth knowledge of gowning and clean room behaviorsExcellent communication skillsAbility to effectively communicate up and down the organizationAbility to utilize team's strengths to efficiently achieve goalsLean Transformation and/or Continuous Improvement experienceEducation and Experience:Bachelor's degree in a scientific or allied health field (or equivalent degree) orMaster's degree or relevant experience background8+ years of commercial GMP industry Manufacturing and Quality Assurance experience in, in a regulated biotechnology/regulated pharmaceutical environment.Hybrid-Eligible RolesIn this Hybrid-Eligible role, you can choose to be designated as:On-Site : work five days per week on-site with ad hoc flexibility.#LI-On-site #LI-ND2Flex 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 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.Company 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 ApplicationAssistance@vrtx.com