Global Head of Quality
As the Global Head 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).
