Senior Vice President of Operational Excellence

2 weeks ago


Bridgewater, Massachusetts, United States Knewin Full time

Position Overview
We are in search of a dynamic and results-driven Senior Vice President of Operational Excellence to spearhead the launch and management of our cGMP Operations within a cutting-edge multi-product cell therapy manufacturing facility. This role is pivotal in the production of both autologous and allogeneic cell therapy products.

Key Responsibilities
The successful candidate will:

  • Lead and mentor a high-performing Operations team dedicated to the clinical and commercial production of cell therapy products, ensuring adherence to cGMP standards.
  • Provide strategic and technical leadership, collaborating effectively with cross-functional teams to ensure timely and compliant manufacturing and product release.
  • Oversee multiple operational centers, ensuring the delivery of high-quality products while monitoring key performance indicators related to Safety, Quality, Compliance, Cost, Delivery, and People.
  • Manage the recruitment, development, and performance evaluation of operational staff.
  • Facilitate operational review meetings and lead initiatives aimed at continuous improvement and efficiency within Technical Operations.
  • Establish and track critical KPIs, keeping stakeholders informed of progress and challenges.
  • Participate actively in regulatory and internal audits, ensuring compliance with industry standards.
  • Collaborate with various functional areas to align with the strategic objectives of the manufacturing site.
  • Build and maintain strong relationships with both internal and external stakeholders.

Qualifications
The ideal candidate will possess:

  • A Bachelor's degree in a relevant field such as science or engineering.
  • A minimum of 12 years of operational experience in a cGMP environment within the biotech or biopharma sector, including at least 5 years in a leadership role.
  • In-depth knowledge of Quality Systems, GMP, FDA regulations, GAMP, ISO standards, and other relevant guidelines.
  • Proven experience in managing commercial manufacturing operations and leading organizations through significant growth phases.
  • Strong ability to forge partnerships and collaborate effectively in a matrixed environment.
  • Excellent problem-solving skills and the capacity to adapt to shifting priorities in a fast-paced setting.
  • A track record of developing cohesive teams with a focus on mission-driven performance.
  • Experience in cGMP manufacturing, particularly in cell or gene therapy, along with expertise in tech transfer, process validation, and project management.
  • Familiarity with Operational Excellence methodologies and Lean Manufacturing principles.
  • Exceptional organizational and communication skills, coupled with a self-motivated and passionate approach to advancing cell therapy.

Compensation and Benefits
The total compensation package includes competitive base salaries, comprehensive medical, dental, and vision plans, retirement matching, and additional perks.



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