VP – Quality Operations
Posted on 11/9/2023

51-200 employees

Automated cell therapy manufacturing and development platform
Company Overview
Cellares, as the pioneering Integrated Development and Manufacturing Organization (IDMO), is reshaping the cell therapy manufacturing industry with its unique Industry 4.0 approach, integrating all necessary technologies into a single, high-throughput platform called the Cell Shuttle. This end-to-end automation system not only accelerates drug development and manufacturing but also significantly reduces process failure rates and manufacturing costs. With its strategically located Smart Factories and a robust financial backing of over $355 million, Cellares is well-positioned to meet global patient demand for cell therapies, offering potential partners a competitive edge in the rapidly evolving cell therapy market.
Data & Analytics

Company Stage

Series C

Total Funding





South San Francisco, California

Growth & Insights

6 month growth


1 year growth


2 year growth

Bridgewater Township, NJ, USA
Experience Level
Desired Skills
Operations & Logistics
  • Bachelor's degree in science, engineering, or related field
  • 12+ years of Quality Management experience within a cGMP environment in the biotech/biopharma industry with a minimum of 5 years of senior leadership experience
  • Work effectively with US FDA and other regulatory agencies
  • Substantial knowledge of Quality Systems, GMP, FDA, GAMP, ISO and other applicable standards
  • Proven experience implementing continuous improvement initiatives to drive Quality programs and ensure maximum productivity
  • Past experience developing, implementing, and monitoring Quality programs, policies and procedures to ensure compliance with GMP standards, corporate policies, FDA, EMA and other regulatory body regulations and guidelines
  • Experience with Operational Excellence and/or Lean Manufacturing
  • Lead, direct, coach, and develop an effective QA and QC team responsible for daily clinical and commercial production of autologous and allogeneic cell therapy products, while ensuring safe and compliant operations according to cGMP requirements
  • Provide technical and managerial leadership by effectively interfacing and collaborating with key stakeholders and functions across the organization to successfully manufacture and disposition products to patients in a timely manner
  • Oversee the hiring, development, and performance management of staff within QA and QC
  • Develop a robust Quality Management System (QMS) that complies with global regulatory requirements
  • Develop a Quality Culture and compliance related manufacturing and process controls to improve quality systems
  • Establish critical KPIs, monitor progress and keep critical stakeholders informed of progress
  • Lead and actively participate in all regulatory and internal audits of the facility
  • Work closely with other functional areas to develop and execute against the strategic plan for the manufacturing site
  • Establish key stakeholder relationships with internal and external stakeholders
Desired Qualifications
  • Cell/Gene Therapy and CDMO experience preferred
  • Serve as the point person with industry partners regarding product quality matters, customer satisfaction levels, and regulatory authority interaction
  • History of developing and building cohesive, high performing teams with a strong sense of mission, providing training and mentoring to build sufficient management depth throughout the organization and ensure strong succession planning
  • Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability
  • Excellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels within the organization
  • Self-motivated and passionate about advancing the field of cell therapy
  • Self-awareness, integrity, authenticity, and a growth mindset