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Associate Director, Product Quality Management, Cell and Gene

Company: Vertex Pharmaceuticals
Location: Boston
Posted on: May 28, 2023

Job Description:

Associate Director, Product Quality Management, Cell and Gene page is loaded Associate Director, Product Quality Management, Cell and Gene Apply locations Boston, MA time type Full time posted on Posted 4 Days Ago job requisition id REQ-19140 Job DescriptionGeneral Summary: The Product Quality Management Lead is accountable for the monitoring, reporting and driving resolution of cell and genetic programs quality activities. This oversight includes establishing processes to maintain and routinely monitor overall Program Quality activities including product quality Life cycle management activities.This includes ensuring internal cross-functional alignment, and identifying product quality project risks and mitigations throughout development for the assigned programs. The role will closely partner with quality and operational stakeholders to participate in Cell & Genetic therapies program oversight and associated governance. Key Duties and Responsibilities: - Develop, lead and implement process to maintain and routinely monitor Program Quality projects including strategy and life cycle management activities. - Participate in the implementation of CMC Quality standards for products and processes for stage gate deliverable working in collaboration with key internal and external stakeholders, embedding the principles of product lifecycle management. - Serve as the PoC for dashboards, monitoring, and reporting. - Chair/Lead appropriate quality governance meetings for the coordination, establishment, and routine monitoring of key Program Quality activities for Quality members covering complex changes, follow up processes and resolution of challenges. - Ensure quality and compliance frameworks, guidance, and systems are in place to keep the products current with industry and health authority regulatory expectations as well as Vertex's QMS for products throughout the life cycle development. - Work with Product Quality Leads to establish dashboards, product Quality project oversight and drive continuous improvements. - Proactively identify, document and drive mitigation of Quality risks and improvement opportunities together with the Program designated Product Quality Lead. Participate in Quality System and Quality Life Cycle Management Projects as assigned by Management. Knowledge and Skills: - In-depth global regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics (ICH/EU/FDA/etc.). - In depth experience in all stages of clinical product development to commercialization product life cycle management. - Direct experience with regulators (e.g., NDA, BLA, MAA submissions and/or inspections). - Broad technical knowledge in AAV/Cell technology, aseptic processing, process & analytical development, manufacturing science & technology, etc. - Ability to lead improvement projects in a matrix environment, influence across stakeholders. - Ability to chair governance meetings, and establish dashboards, reporting. - Experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma. - Excellent communication skills; proven track record Influencing/building/promoting a culture of Quality Excellence. - Ability to apply critical thinking and problem solving skills to decision making and operational priorities. Strong leadership and an innate ability to collaborate and build relationships Education and Experience: - Bachelor's degree in an engineering/Lifesciences field. - Master's degree or relevant comparable background. - Typically requires 10+ years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment. - A minimum of 3 years leadership experience leading teams or directing allocation of resources is preferred. We're enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid, or On-Site-Eligible role, you can -choose to work: 1. - On-Site -and work 5 days per week with ad hoc flexibility; 2. - Hybrid - and work remotely up to two days per week on regularly scheduled days; -or select #LI-AR1 #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 Similar Jobs (5) Associate Director, Quality Systems Cell and Gene locations Boston, MA time type Full time posted on Posted 7 Days Ago Associate Director, GMP QA Product Quality locations Boston, MA time type Full time posted on Posted 8 Days Ago About Us 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 multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) - a rare, life-threatening genetic disease - and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational small molecule, cell and genetic therapies in other serious diseases where it has deep insight into causal human biology, including sickle cell disease, beta thalassemia, APOL1-mediated kidney disease, pain, type 1 diabetes, alpha-1 antitrypsin deficiency and Duchenne muscular dystrophy.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 and Latin America. Vertex is consistently recognized as one of the industry's top places to work, including 13 consecutive years on Science magazine's Top Employers list and one of Fortune's Best Workplaces in Biotechnology and Pharmaceuticals and Best Workplaces for Women. For company updates and to learn more about Vertex's history of innovation, visit -or follow us on Facebook , - Twitter , - 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.

Keywords: Vertex Pharmaceuticals, Boston , Associate Director, Product Quality Management, Cell and Gene, Executive , Boston, Massachusetts

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