Associate Director, Quality, Raw Materials & External Manufacturing, Cell & Genetic Therapies

Company: Vertex Pharmaceuticals
Location: Cambridge
Posted on: May 12, 2022

Job Description:

Job DescriptionGeneral SummaryThe Associate Director, Quality of Raw Material External Manufacturing, responsible for the quality oversight of critical components Contract Development and Manufacturing Organizations (CDMOs) for Cell & Genetic Programs through the lifecycle development process. This includes quality oversight for the selection, qualification and routine monitoring of Contract manufacturers and laboratories. The quality role will closely partner with operational stakeholders and participate in associated governance for the successful planning and execution of program CMC strategy. The successful candidate will be a key member of the Vertex Cell & Genetic Therapy Quality Team.The role is responsible for collaborating with internal stakeholders to develop and maintain relationships and drive compliance and continuous improvement activities within critical component contract manufacturers and associated laboratories.Key Duties & ResponsibilitiesBe the Quality expert for critical component contract development and manufacturing organizations.

• Participate in cross functional teams to determine enhancements to quality systems and support the closure of compliance gaps at raw material contract manufacturers.
• Build strategic relationships with CDMOs within the Quality organization and participates in Business Review Meetings to ensure Quality issues are raised and addressed, as necessary.
• Negotiate, monitor and maintain Quality Agreements with CMOs.
• Liaises with cross-functional teams for external quality commercial operations in support of GMP manufacturing and testing activities, including disposition of critical raw materials.
• Monitors quality processes, metrics and drive quality remediation and continuous improvement activities.
• Work closely with the Audit and Inspection Quality Function to establish the audit strategy for Auditing and Performance oversight and support technical site audits including preparation for regulatory inspections.
• Establishment of vendor quality oversight processes including qualification, risk categorization and routine monitoring.
• Provide guidance and support through Quality representation in relevant geographies at periodic intervals on site at the CDMOs.
• Supports root cause analysis and product impact assessments for investigations resulting from deviations and OOS.
• Responsible for the quality review and approval of critical component change controls for development and commercial processes, assess impact and implementation activities.
• Participate in Cell & Genetic Program and Quality projects.Required Knowledge/Skills
  • In-depth global regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics. - Experience in product life cycle from discovery to commercials product development
    • Broad understanding of regulatory environment including quality systems, compliance and strategy.
    • Broad technical knowledge in Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing.
    • 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.
    • Ability to apply risk management principles to decision making and operational priorities.
    • Critical Thinking and Problem-Solving skills
    • Strong leadership and an innate ability to collaborate and build relationships.Required Education Level
      • Bachelor's degree in a biotech/Lifesciences field.
      • Master's degree or relevant comparable background.
      • Typically requires 6+ years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environmentWe'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. Hybrid and work remotely up to two days per week on regularly scheduled days; or select2. On-Site work 5 days per week with ad hoc flexibility.#LI-ND1 #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.Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. 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.

Keywords: Vertex Pharmaceuticals, Cambridge , Associate Director, Quality, Raw Materials & External Manufacturing, Cell & Genetic Therapies, Healthcare , Cambridge, Massachusetts