岗位职责：

1.Vendor Qualification and Management:

a.Lead the qualification process for new GxP vendors, including Contract Research Organizations (CROs), Clinical Laboratories, GLP Laboratories, GxP IT computerized system/software vendors, Pharmacovigilance (PV) third parties, etc.

b.Conduct risk-based assessments and evaluations of vendors to ensure compliance with regulatory requirements and internal company standards.

c.Manage the approved global vendor list and ensure all vendors are qualified, approved, and monitored according to company policies.

2.Vendor Audit and Inspection Support:

a.Provide input from an audit focus area perspective to Audit & Compliance during the vendor audit planning stage.

b.Act as a Subject Matter Expert (SME) for vendor quality and provide support to the inspection management team before, during, and after the audit and regulatory inspection.  

3.Compliance and Documentation:

a.Develop and maintain vendor-related quality agreements, ensuring clear roles and responsibilities for GxP compliance are established.

b.Ensure proper documentation of all vendor quality activities, including qualification records, and risk assessments.

c.Monitor vendor quality performance through Key Performance Indicators (KPIs) and Quality Metrics, providing regular reports to senior management.

4.Cross-Functional Collaboration:

a.Collaborate with internal stakeholders, including business functions, procurement and legal to align on vendor quality requirement.

b.Support the resolution of vendor-related issues that impact quality, data integrity and scientific integrity, timelines or compliance.

5.Continuous Improvement:

a.Lead continuous improvement initiatives related to vendor quality management processes.

b.Stay current with industry best practices, regulatory changes, and trends in GxP compliance, and implement changes to maintain an industry-leading vendor quality program.

资历要求：

• Bachelor’s or Master’s degree in Life Sciences. Pharmacy, Medicine, or a related field.
• 8–10 years of relevant experience in Quality Assurance and/or Clinical Development within the pharmaceutical, biotechnology, or medical device industry, including a minimum of 5 years in GCP/GLP/GVP vendor or supplier quality management, covering:

1. GCP/GLP/GVP Quality Assurance and Vendor Quality oversight.
2. Execution and management of GCP/GLP/GVP vendor qualification, audit, and monitoring programs, applying a risk based approach.
3. Support of regulatory inspections and health authority interactions.
4. In depth knowledge of international GxP regulations and guidance, including FDA, EMA, PMDA, NMPA, MFDS, ICH, GDPR, GAMP 5, and 21 CFR Part 11, with practical experience in Computerized System Validation (CSV).
5. Experience in CAPA management and QMS implementation, maintenance, and continuous improvement.
6. Manage work effectively in a global, hybrid working environment.
7. Exposure to Clinical Development, Clinical Operations, Pharmacovigilance, Medical Affairs, and vendor managed services is highly desirable.

• Strong business level proficiency in written and verbal English, with the ability to communicate clearly and professionally in a global business environment.
• Strong leadership and project management skills to manage multiple tasks and projects in a fast-paced, ambiguous and complex environment, with confidence, identifying opportunities and developing clear action plans.
• Take initiative to lead cross functional team with minimal direction in driving projects forward and achieving result, even in the absence of complete information or established processes and defined goals or outcomes.
• Excellent written and verbal communication skills, with the ability to interact effectively with internal teams and external vendors.
• Detail-oriented with strong problem-solving skills.  
• Strong interpersonal skills with demonstrated ability to build collaborative relationships.
• Strong expertise in continuous improvement and change management.
• Strong conflict resolution/negotiation skill.
• 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 Sparta TrackWise eQMS System is an advantage.