Global Head of Regulatory Compliance (CDMO)

Job Title: Head of Global Regulatory Compliance for CDMO QA/QC

This is a remote position with preference of a candidate on the East Coast. This individual will be required to travel to their testing sites - 1 week / month. Their sites are:

1. Memphis, TN
2. Hanover, MD
3. Rockville, MD
4. Keele, Newcastle, UK

Summary: Lead regulatory compliance and quality assurance efforts for Cell and Gene Therapy within a multisite Contract Drug Manufacturing Organization (CDMO). Provide guidance, establish and improve quality systems, and ensure compliance with global regulatory standards (FDA, EMA, HPRA, etc.). Engage clients and new customers to support Quality organization initiatives.

Key Responsibilities:

• Develop and implement regulatory strategies, objectives, and processes across business units and CDMO partners to elevate quality and compliance.
• Oversee QA/QC teams, ensuring Quality Management Systems (QMS) meet regulatory requirements and operate efficiently.
• Represent the company in interactions with clients, regulators, and industry experts.
• Serve as the main point of contact for regulatory agencies.
• Promote a quality culture within the organization by providing guidance and input at business meetings.
• Develop and implement global GMP CGT training programs, addressing emerging issues and advancing compliance knowledge.
• Foster continuous improvement within the QA organization.
• Recruit, develop, and lead high-performing QA teams, promoting collaboration and a positive team culture.
• Collaborate with stakeholders to implement test automation strategies, monitor performance metrics, and ensure regulatory compliance.

Qualifications:

• Bachelor’s degree in a scientific discipline or related field; advanced degree in biological sciences, pharmaceutical science, or computer sciences preferred.
• 15+ years of experience in QA, Quality Control, or Regulatory Affairs in the pharmaceutical/biotechnology industry.
• 5+ years of oversight of multiple global operations sites.
• Proven ability to build strong relationships and collaborate effectively across departments.
• Experience with strategic M&A integrations.
• In-depth knowledge of GMP, governmental regulations, and quality standards.
• Travel: 20%-30% domestic and international.
• Familiarity with 21 CFR Parts 11, 210, 211, 600 series, 800 series, and related guidance documents (US and international).