China Quality Assurance Head

The China Quality Assurance Lead & Qualified Person (QP) will be responsible for
establishing, implementing, and continuously improving the Company's Quality
Management System (QMS) in China to ensure compliance with applicable NMPA
regulations, GMP requirements, and MAH (Marketing Authorization Holder) obligations.
The incumbent will serve as the Company's Qualified Person in China, independently
performing batch disposition and product release responsibilities in accordance with
applicable regulations.
This position also provides quality oversight of outsourced Pharmacovigilance (PV)
activities to ensure that post-marketing safety obligations are fulfilled through qualified PV
service providers. Daily PV operations are performed by an external vendor.
Qualifications:
• Bachelor's degree or higher in Chemistry, Pharmacy, Biochemistry or a related
discipline
• Licensed Pharmacist
• Meet the qualification requirements for both Head of China Quality and Qualified
Person under applicable China MAH regulations
• Demonstrated expertise in GMP, GCP, and GLP compliance and a strong
understanding of China (NMPA) and global regulatory standards (FDA, EMA, ICH).
• Minimum of 5 years working in Pharmaceutical Quality Assurance with direct
Quality Management Systems experience.
• Previous direct experience working in pharmaceutical manufacturing or quality
control.
• Experience providing quality oversight of contract manufacturing organizations
(CMO/CDMO) highly desirable.
• Experience with QMS platforms (e.g., Veeva, Trackwise)
• Previous experience as Quality Manager, Head of Quality, Quality Director, or
Qualified Person is preferred.
• Flexibility to work with global QA and corporate teams
• Must be able to work and communicate independently
Responsibilities
The China Head of Quality, Qualified Person (QP) & PV Lead will serve as the senior Quality
representative for all operations within China. This role requires strategic leadership,
hands-on management, and a deep understanding of China-specific regulatory
requirements and quality systems for pharmaceutical drug substance and drug product.
The China Head of Quality, Qualified Person (QP) & PV Lead will develop, implement, and
expand the Company’s Quality Management System for the Chinese market. The
incumbent will also serve as the registered QP, performing all batch review, certification,
and release activities for the China market. Additional responsibilities include oversight of
local pharmacovigilance activities and compliance with local and regional requirements.
Core Responsibilities Include:
Quality Assurance:
• Expand Company’s Quality Management System for the China market, ensuring a
state of perpetual inspection readiness.
• Provide QA oversight for all GxP activities
• Develop, review, and approve Quality Agreements and other critical compliance
documents
• Ensure local compliance with all ICH, NMPA, and local regulations.
• Perform supplier audits, evaluations, and qualification activities as needed.
• Review and release all drug substance and drug product batches for the China
market, including review of OOS, Batch Records, CoA/CoC, and all other GxP
documentation.
Qualified Person (QP) Responsibilities:
• Review manufacturing and testing documentation supporting batch disposition.
• Ensure all commercial batches meet approved specifications.
• Verify compliance with approved manufacturing processes.
• Confirm deviations, investigations, OOS results, CAPAs and change controls have
been appropriately assessed prior to release.
• Review Product Quality Reviews (PQR/APQR).
• Ensure supplier qualification requirements are met.
• Support product recalls and market actions when required.
• Ensure stability commitments are maintained.
• Approve disposition of commercial drug product.
• Support importation and release activities where applicable