Head of Department

Global Head of CDMO QA/QC Regulatory Compliance - 100% Remote role with travel 20%

The Executive Director will provide direction and leadership as regulatory Subject Matter Expert in Cell and Gene Therapy Quality Systems and provide guidance and support for multisite Contract Drug Manufacturing Operations (CDMO) compliance program designs and/or QA/QC activities. The individual will have oversight of various business unit QA/QC teams to establish/improve the Quality Units regulatory knowledge and either establish or improve quality systems and processes specific to the Cell and Gene Therapy platform supporting GMP activities while ensuring compliance with all appropriate worldwide governmental regulatory agencies ( FDA, EMA, HPRA, etc) and corporate policies to avoid any business interruption.

Requirements:

• Provide input into the development of regulatory strategy, objectives, and processes across the CGT Business Units and with CDMO business partners that fundamentally raise the importance of quality/compliance within the organization. Work directly with senior corporate operations management teams to ensure regulatory compliance and consistency with Charles River policies and procedures.
• Oversight of CDMO QA/QC Business Units, assess that Quality Management Systems (QMS) meet regulatory requirements and that processes and systems are efficient and effective.
• Interact with clients, regulators and/or industry experts to represent CRL interests, as appropriate.
• Serve as the coordination contact for governmental regulatory agencies ( i.e.. FDA, HPRA, EMA and other agencies) relating to such matters.
• Build an environment to optimize employee compliance and add quality culture values to the organization by actively providing guidance or input into business team meetings.
• Provide assistance with the development and implementation of global GMP CGT training programs to provide compliance managers and staff in designated staff functions and/or businesses with the knowledge and experience to advance the strategic objectives of the Corporate Compliance Program. Identify emerging issues and the training experiences necessary to enable the staff in addressing these issues at the various global CGT sites.
• Recruit, develop, and lead high-performing QA teams, fostering/creating a positive and collaborative team culture in support of the CRL Values of Lead, Own, Collaborate and Care
• Collaborate with stakeholders, implement test automation strategies, monitor performance metrics, and ensure regulatory compliance to drive effective quality assurance processes.

Qualifications:

• Education: Bachelor’s degree (B.A. /B.S.) or equivalent in scientific discipline or related field. Advanced degree in biological sciences, pharmaceutical science or computer sciences preferred.
• Experience: Fifteen (15) or more years related experience in a pharmaceutical and/or biotechnology-related industry having direct responsibility for QA/ Quality Control/Regulatory Affairs. Minimum of 5 years oversight of multiple Global Operations sites
• Experience/familiarity with CDMO
• Ability to build strong relationships and collaborate effectively across departments.
• Experience with Strategic M&A integrations
• In-depth knowledge of GMP, governmental regulations, and other relevant quality standards.
• Must be willing to travel 20-30%