Position: Vice President, Head of Quality
Location: Shanghai, P.R. China
Reports to: CEO
The Vice President, Head of Quality will be responsible for leading all quality-related activities and shaping the global quality strategy for a leading organization in the contract development and manufacturing space. This executive will ensure compliance with
FDA, EMA, NMPA, and other international regulatory standards
while driving continuous improvement across the quality management system.
The ideal candidate brings deep expertise in
biopharmaceutical quality management, risk assessment, and process validation
, with a proven record of success in
BLA submissions
and quality oversight of both clinical and commercial manufacturing. This role requires a strong strategic mindset, the ability to collaborate across functions, and the leadership skills to foster a culture of excellence and compliance.
Key Responsibilities
- Provide leadership for quality assurance and quality control functions across global clinical and commercial manufacturing sites.
- Maintain and continuously improve the
quality management system (QMS)
in alignment with FDA, EMA, NMPA, and ICH requirements. - Ensure adherence to cGMP regulations, including preparation for and oversight of audits and regulatory inspections.
- Mentor and develop global quality teams while cultivating a culture of compliance, accountability, and continuous improvement.
- Stay current with evolving regulatory requirements and ensure proactive alignment across the organization.
- Lead initiatives to enhance manufacturing processes, reduce risk, and improve overall product quality.
- Partner cross-functionally with R&D, Manufacturing, Engineering, and Supply Chain to integrate quality principles into all aspects of operations.
Qualifications
- Advanced degree in Life Sciences, Pharmacy, Engineering, or related field.
- 15+ years of quality management experience
in the biopharmaceutical sector, including at least 5 years in a senior leadership role. - Deep expertise in
FDA, EMA, and NMPA GMP regulations
as well as ICH guidelines. - Demonstrated success with
BLA submissions
(FDA/EMA preferred). - Proven leadership experience with global quality teams.
- Strong analytical and problem-solving skills, with excellent communication and stakeholder management abilities.
- Professional fluency in English.