Legal Jobs in Jing'an District, China (Now Hiring) — 5 open

F) Stakeholder Relationships

• CM Interface: Develop and maintain professional relationships with quality and technical personnel at CMs in China, serving as the primary Lilly QA interface.
• Affiliate Collaboration: Collaborate with Lilly China Affiliate personnel including regulatory affairs and medical functions to align on MAH obligations and local compliance.
• Global Functions: Interface with Lilly TSMS, AQCO, GQAAC, and other Manufacturing sites to ensure consistent global quality standards while meeting local requirements.
• Regulatory Engagement: Engage proactively with NMPA and local provincial drug regulatory authorities as appropriate, in coordination with Lilly Regulatory Affairs.

• Degree: Bachelor’s or above in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or a related discipline. Pharmacy strongly preferred per NMPA key personnel qualification expectations.
• English: Advanced proficiency (written and spoken) required for global quality system management, regulatory documentation, and cross-functional communication.
• Mandarin: Proficiency required to interface with CMs, interpret NMPA guidance, and support regulatory inspections in China.

• Quality / Technical: 8–10 years in quality or technical functions within pharmaceutical manufacturing or external manufacturing quality oversight.
• Leadership: 3–5 years managing cross-functional or remote quality teams.
• Chinese GMP: Demonstrated experience with NMPA inspection preparation; direct NMPA GMP inspection experience highly preferred.
• MAH System: Experience operating under China’s MAH system, including MAH quality accountability obligations and delegation requirements.
• CM Oversight: Experience managing quality oversight of contract manufacturers, preferably solid oral dosage form operations.
• International GMP: Familiarity with ICH Q7, Q10; EU GMP; US FDA cGMP — ability to manage dual-compliance requirements.

• Chinese GMP: In-depth knowledge of Chinese GMP (2010 revision), NMPA requirements, and the MAH accountability system.
• Quality Systems: Strong understanding of pharmaceutical quality processes: deviations, change control, CAPA, complaints, batch release, periodic product review.
• Data Integrity: Thorough understanding of ALCOA+ principles and NMPA/ICH data integrity expectations.
• Cultural Agility: Effective cross-cultural communication and relationship management for China-based contract manufacturing operations.
• Risk Thinking: Analytical, risk-based approach to quality assessment and prioritisation at complex external manufacturing sites.
• Travel: Willingness and ability to travel up to 30%, including CM and Lilly sites across China or international travel.

The following table captures the regulatory accountability of this role under Chinese pharmaceutical law, supporting inspection readiness and MAH compliance documentation.

Quality Oversight

Scope: Full authority to approve, reject, or escalate quality decisions on behalf of the MAH for all Dry-EM CM operations in China.

Regulatory Basis: China DAL (2019) Art. 30–38

GMP Compliance

Scope: Accountable for CM adherence to Chinese GMP (2010) and applicable NMPA supplementary guidelines for solid oral dosage forms.

Regulatory Basis:Chinese GMP (2010) Ch. II, III

Data Integrity

Scope:Ensures all CM quality records meet ALCOA+ principles and NMPA data integrity requirements.

Regulatory Basis:NMPA DI Guidelines; ICH Q10

Inspection Interface

Scope: Primary MAH quality representative during NMPA inspections; responsible for inspection commitments and regulatory responses.

Regulatory Basis:Chinese GMP (2010) Ch. VII

Regulatory Notification

Scope: Initiates and manages notifications to Lilly functions and NMPA for significant quality events including defects and recalls.

Regulatory Basis:China DAL Art. 84–86