Demo

Vice President of Quality

Mantell Associates
Boston, MA Full Time
POSTED ON 3/9/2025
AVAILABLE BEFORE 6/6/2025

Mantell Associates are partnered with a high-quality research organisation in their search for a VP of Quality who will be a key member of the senior leadership team and hold responsibility for building, leading and executing a quality strategy.

VP of Quality - Responsibilities :

  • Startup Support : Support the startup of the facility through Quality oversight of commissioning, qualification, and validation activities, ensuring that quality systems and processes are fully operational upon facility launch.
  • Team Leadership & Development : Build and lead the Quality team, recruiting, training, and developing talent in Quality Assurance (QA) and Quality Control (QC). Foster a collaborative, high-performance Quality culture across the site.
  • GMP Compliance & Oversight : Ensure the site complies with all GMP regulations, maintaining inspection readiness throughout product lifecycles. Lead regulatory inspections (FDA, EMA, etc.) and client audits.
  • Quality Systems & Improvement : Oversee the development and maintenance of site-specific Quality systems. Lead continuous improvement efforts to optimize quality assurance and operational efficiency.
  • Collaboration & Site Leadership : Partner with Manufacturing, MSAT, Facilities, Engineering, IT and other departments to integrate quality across site operations. As a member of the site leadership team, collaborate with the Site Head to align on strategic goals and quality priorities.
  • Client Programs Collaboration : Collaborate with Business Development and Program Management teams to support Quality aspects of client-contracted programs, aligning with client expectations and project timelines.

VP of Quality - Requirements :

  • Bachelor’s degree in a scientific discipline with at least 15 years of experience in a pharmaceutical, biotechnology or biologics operation, including 10 years of experience in GMP Quality settings.
  • Expert knowledge of GMP, FDA and EMA regulatory requirements applicable to Advanced Therapies including Cell Therapy, Gene Therapy (Viral and non-viral), and RNA therapy products and aseptic manufacturing processes preferred.
  • Experience in working in a Contract Manufacturing environment preferred.
  • Working knowledge and demonstrated ability to apply GMPs across early and late clinical phases.
  • Excellent communication skills with a customer service mindset.
  • Strong leadership, teamwork and problem-solving skills.
  • Experience leading and training others in root cause investigations, deviations, OOS and CAPA.
  • Technical proficiency & knowledge in use of enterprise electronic data management and execution systems (i.e. ERP, QMS, DMS, LIMS, and MES).
  • Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at 44 (0)20 3854 7700.

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