Sr Director/ Director of Quality - CDMO
Working Situation: Onsite
Location: Tennessee
As the Sr Director of Quality, you will be responsible for ensuring the highest standards of quality across multiple international sites, encompassing approximately 200 employees. You will play a pivotal role in overseeing Quality Management System (QMS) integration, CDMO (Contract Development and Manufacturing Organization) operations, Biologics and CAR-T product manufacturing, and compliance with cGMP standards. This role requires a strong understanding of FDA and EMA regulatory requirements, as well as experience managing and navigating audits from these regulatory bodies.
Key Responsibilities:
- Lead and manage a global team of Quality Assurance professionals to ensure consistent adherence to cGMP standards and regulatory requirements.
- Develop and implement global quality strategies and initiatives that align with corporate objectives and regulatory expectations.
- Oversee the integration and harmonization of Quality Management Systems across all sites, promoting efficiency and standardization.
- Provide oversight and support for all aspects of CDMO operations related to Biologics and CAR-T product manufacturing.
- Collaborate closely with cross-functional teams including Manufacturing, Regulatory Affairs, and R&D to drive continuous improvement in quality processes and systems.
- Serve as the primary point of contact for FDA and EMA inspections and audits, ensuring readiness and compliance at all times.
- Monitor and analyze quality metrics and KPIs to identify trends, implement corrective actions, and drive a culture of quality excellence.
- Champion a culture of quality and compliance throughout the organization, promoting awareness and accountability at all levels.
Qualifications:
- Bachelor's degree in a scientific or engineering discipline; advanced degree (Master's, PhD) preferred.
- Minimum of 15 years of progressive experience in Quality Assurance within the biopharmaceutical industry, with at least 5 years in a leadership role overseeing global operations.
- Extensive knowledge and experience with Biologics and/or CAR-T product manufacturing processes and regulatory requirements.
- Proven track record of successfully managing FDA and EMA audits and inspections.
- Strong leadership and communication skills with the ability to influence and collaborate across diverse teams and cultures.
- Strategic thinker with the ability to translate strategic plans into actionable quality initiatives.
- Experience in implementing and maintaining effective QMS across multiple international sites is highly desirable.
- Ability to travel internationally as needed (approximately 30-40% travel expected).
