Senior Director, IDMO Site Quality

We are seeking a highly motivated Senior Director of IDMO Site Quality who will play a critical role in the launch, ramp-up, and oversight of cGMP Operations within a state-of-the-art multi-product cell therapy manufacturing facility that will be utilized to manufacture autologous and allogeneic cell therapy products.

This individual will lead the Quality organization (QA/QC) and partner with other functions to produce cell therapy products through safe and compliant manufacturing operations according to cGMP requirements by leveraging and expanding the site Quality Management Systems (QMS) and ensuring regulatory compliance. This individual will provide strategic leadership to ensure alignment with customer needs and business strategies. As such, the role will require proven leadership to drive effective communication, coordination, and collaboration across relevant cross functional groups to ensure robust production, testing, and release of product to patients.

This is a multidisciplinary role & this individual will need the ability to interface with all levels of the organization, including Operations, MS&T, Process/Analytical Development, Supply Chain, Warehouse, Training, Engineering/Facilities, HS&E, and Finance.

The successful candidate should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.

• 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 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

• Bachelor's degree in science, engineering, or related field required
• 10+ years of Quality Management experience within a cGMP environment in the biotech/biopharma industry with a minimum of 5 years of senior leadership experience
• Cell/Gene Therapy and CDMO experience preferred
• 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
• Ensure Quality systems meet the needs of all internal and external stakeholders with an emphasis on process, quality, productivity, budget control, and profitability
• 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
• Serve as the point person with industry partners regarding product quality matters, customer satisfaction levels, and regulatory authority interaction
• Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members
• 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…