岗位职责：

1.GCP/GLP/GVP SOP Oversight & Regulatory Compliance

a.Serve as GCP/GLP/GVP QA Subject Matter Expert responsible for review and quality assurance of all GCP/GLP/GVP-related SOPs.

b.Ensure SOPs are comprehensive, cross-referenced, and compliant with evolving international GCP/GLP/GVP standards (ICH E6 GCP, US 21 CFR Parts 50,56, 312, 812), EU Clinical Trial Regulation (CTR) No.536/2014, Japan GCP, and China GCP, OECD Principles of Good Laboratory (GLP), EU GVP Modules I-XVI, US FDA 21 CFR 314.80, 600.80, 606.170 & PV guidance, Japanese GVP Ordinance & MHLW GVP Ministerial Ordinance, and China GVP etc.).

c.Lead SOP landscape reviews to identify gaps, redundancies, and misalignments; drive harmonization across global SOPs.

2.Regulatory Inspection or Audit Support

a.Serve as the main QMS liaison for GCP/GLP/GVP inspections (e.g., FDA, EMA, PMDA, NMPA) or audits. Responsibilities include:

i.Assisting with the inspection preparation and strategy.

ii.Participating in inspections or audits to ensure consistent messaging and proper documentation.

iii.Providing QMS input for CAPA responses and follow-up actions after inspection or audit to ensure effectiveness and sustainability.

3.Quality Management System Support

a.Collaborate closely with Functional QA and provide expertise in the implementation, maintenance, and continuous improvement of the QMS.

b.Evaluate trends, quality metrics, and audit findings to drive continuous improvement initiatives.

4.GCP Training and Capability Building

a.Partner with the Functional QA to develop, deliver, and maintain training programs and materials on:

i.GCP/GLP/GVP and other evolving regulatory requirements.

ii.Quality and GCP/GLP/GVP inspection readiness topics tailored for respective business function and Functional QA.

5.Regulatory Intelligence & Compliance Monitoring

a.Work cross-functionally with Regulatory Affairs to proactively collect and assess GCP/GLP/GVP regulatory intelligence from key markets (e.g., US, EU, Japan, China).

b.Ensure timely communication of new or evolving GCP/GLP/GVP regulations and support their integration into GCP/GLP/GVP-related SOPs, training materials and QA processes.

资历要求：

• Bachelor’s or Master’s degree in Life Sciences. Pharmacy, Medicine, or a related field.
• Minimum 10 years of relevant GCP/GLP/GVP experience in the pharmaceutical or biotechnology industry, including:

1. GCP/GLP/GVP Quality Assurance or Clinical or PV Quality Management.
2. GCP/GLP/GVP Audit Program execution or management.
3. Regulatory inspection support.
4. In-depth knowledge of ICH and relevant global GCP/GLP/GVP regulations (FDA, EMA, PMDA, NMPA, etc.) frameworks and evolving requirements.
5. Experience in CAPA development and QMS implementation/improvement.
6. Exposure to Clinical Development, Clinical Operation, Medical Affairs and Pharmacovigilance operations.

• Strong business level proficiency in written and verbal English, with the ability to communicate clearly and professionally in a global business environment. 
• Excellent written and verbal communication skills
• Critical thinking and problem-solving mindset with strong analytical abilities.
• Ability to influence and collaborate cross-functionally across clinical, medical affairs, PV, regulatory affairs and R&D & PV QA team
• Demonstrate ability to manage multiple priorities in a global, matrix environment.
• Proficient in Microsoft Word, Excel, and PowerPoint.
• Familiar with AI tools (e.g., ChatGPT, DeepSeek, Microsoft Copilot), with the ability to create effective prompts for quality search and business outputs.
• Experience with Veeva Vault QualityDocs, UL ComplianceWire and Sparta TrackWise eQMS System is an advantage.