Quality Director, Manufacturing Process (Hybrid)

Job Description

The Quality Director - Manufacturing Process will lead operational excellence efforts to identify and drive improvements across the CGT Quality operations by implementing industry best practices, methodologies, and systems aimed at risk-based compliance and efficient quality operations. The role requires a strategic leader with extensive experience in quality management, operational excellence, and change management to foster a culture of continuous improvement.

The role involves developing, leading and implementing process improvements and developing performance metrics with cross functional partners.

Key Duties and Responsibilities:

• Lead the development and execution of the organization's quality and operational excellence strategy, ensuring alignment with overall business goals.
• Critically analyze and assess current Quality operational processes to identify the areas of improvement and simplification.
• Leverage industry best methodologies such as Lean Six Sigma or other operational excellence methodologies, across Quality operations to drive efficiencies.
• Utilize critical thinking to assess and compare processes across various CDMOs to drive consistency and uniform Batch Records (Master Batch Records) creation and continuous improvements.
• Cross-Functional Collaboration:Work closely with senior leadership, cross-functional partners such as External Manufacturing, QC, MSAT and others to drive quality initiatives, troubleshoot operational challenges, and optimize processes.
• Data-Driven Decision Making:Analyze operational performance data and key performance indicators (KPIs) to identify trends and implement data-driven solutions for improving quality and efficiency.
• Champion change management efforts, ensuring successful adoption of new tools, processes, and systems to achieve quality and operational objectives.

Knowledge and 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 technical knowledge in manufacturing unit operations.
• Skills:
  • Strong leadership and communication skills.
  • Expertise in Lean, Six Sigma, or similar methodologies.
  • Results driven execution and tracking.
  • Experience in process mapping and root cause analysis.
  • Ability to lead and inspire cross-functional teams.
  • Experience with quality management software and ERP systems.
  • Critical thinking skills and attention to detail
• Ability to thrive in a fast-paced, dynamic environment.
• Strong interpersonal skills to lead projects and engage with stakeholders at all levels.
• Change management and organizational development experience.

Education and Experience:

• Education:Bachelor's degree in engineering, Bio-medical engineering or related scientific degree.
• Certifications: Six Sigma Black Belt, Lean Certification, or equivalent operational excellence qualifications.
• Experience:At least 10+ years of experience in quality management, and continuous improvement roles, with a proven track record in leadership and process optimization.

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 canchoose to work:

1.Hybridand work remotely up to two days per week;or select

2.On-Site andwork 5 days per week with ad hoc flexibility.

#LI-AR1 #LI-Hybrid

Flex Designation:

Flex Eligibility Status:

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 ApplicationAssistance@vrtx.com