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Quality Director – Manufacturing Process
| Company | Vertex Pharmaceuticals |
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| Location | Boston, MA, USA |
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| Salary | $182400 – $273500 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Expert or higher |
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Requirements
- 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.
- 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.
- Bachelor’s degree in engineering, Bio-medical engineering or related scientific degree.
- Six Sigma Black Belt, Lean Certification, or equivalent operational excellence qualifications.
- At least 10+ years of experience in quality management, and continuous improvement roles, with a proven track record in leadership and process optimization.
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.
- 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.
- 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.
Preferred Qualifications
No preferred qualifications provided.
