Senior Director, IDMO Site Quality

United States·BridgewaterFull Timesenior

OtherDirector

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Overview

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…

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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 skills with ability to influence and build strong working relationships at all levels within the organization

Experience with Operational Excellence and/or Lean Manufacturing

Excellent organizational and communication skills

Self-motivated and passionate about advancing the field of cell therapy

Self-awareness, integrity, authenticity, and a growth mindset