质量服务专家

Key Individual Accountabilities / Deliverables

In this exciting opening within our Quality Services organization, Quality Service expert role specializes in delivering Quality and regulatory support to key customers through all Life Science portfolio. You’ll be interacting with multiple biopharma companies that are pioneering​​ this industry, to deliver quality knowledge and insight for the critical quality issues or inquiries. The role needs to closely collaborate with cross-functional teams in global, such as, Sales, Technical, Customer Excellences, Manufacturing sites, Product managers, Regulatory and other Quality functions.

We are looking for bright, enthusiastic candidates who have the ambition to success in the growing biopharmaceutical industry. Ideal candidate would be a good team-player and work well under pressure. Hands on experience from biopharma Quality or Production would be preferred. You should be fluent in English and Chinese (Mandarin).

1. Quality Services

• Is responsible for Customer Quality and Regulatory resolution and follow-up of Quality incidents.

• Foster customer intimacy and provide customers with updates to Quality complaint investigations including face-to-face meetings as needed.

• Demonstrate expertise in project management, typically in the form of coordinating complex customer inquiries or investigations across global sites.

• Possess an in-depth knowledge of Our products and industry applications and act a Subject Matter Expert for other QS Team Members.

• In-depth understanding relevant regulatory guidelines (i.e., GMP) as it relates to the Pharma, BioPharma, IVD, Medical Devices, Food, Research Markets, etc.

• Deliver Quality Services, adopting a consultative approach to understand customer needs, explain our quality systems capabilities and communicate that commitment.

• Implements standards to ensure customer satisfaction for quality and regulatory matters for the whole Life Science portfolio.

• Implements policies, procedures and methods to provide quality and regulatory product and service information and continuously improves the same.

• Collects data in partnership with Business partner for the Commercial and Business Areas to monitor, report and improve Quality performance from a customer’s perspective.

• Directs the resolution of highly complex or unusual business problems applying advanced analytical thought and judgment.

• Applies broad industry and commercial awareness to drive financial and quality performance across Life Science business sector.

• Interacting with Manufacturing site, Marketing, Sales, Supply Chain, Regulatory and other Quality teams to ensure inquiries are moving forward. Assists other QS Team Members with Inquires that have stalled.

• Contributes / Leads internal facing relevant (quality services, operations, marketing, sales, etc.) training/ education courses

2. Quality Complaint Resolutions

• Facilitate the Quality complaints from key customers in China.

• Act as a local interface for the Quality complaints, domestic troubleshooting (Quality Collaboration Program) and investigational actions (China Quality Complaint Improvement).

• Deliver specific customer Quality expectations and domestic findings to the overseas manufacturing sites.

• Directs the resolution of highly complex Quality defect and issues through effective coordination of investigation process together with Quality investigation center, site Quality and other stakeholders, such as, R&D, Product Managers, Technical experts, etc. Address customer expectations to investigation letter based on advanced analytical thought and judgment in a scientific manner.

• Monitor and report the Quality complaint metrics. Contribute to improve product Quality performance from a customer’s perspective.

• Travel 20%

Education

Bachelors' in Biological sciences (Microbiology, Biochemistry, Molecular biology, Biotechnology, etc.). Master's degree with related scientific area would be preferred.

Work Experience

Must: 4 - 9 years of professional GMP background from pharmaceutical QC, QA or Production with Hands-on Deviation investigation experience or related Project Management experience

Desired: Certified Lead Investigator, Deviation reviewer/approver, Project management professional

Key Skills/Knowledge

• Excellent interpersonal, verbal and written communication skills. Fluent in English and Chinese.

• Good understanding on the Biopharma Quality concepts and working knowledge of FDA and/or EMA, cGMP regulatory requirements.

• In-depth understanding with the deviation, OOS investigation and CAPA planning in compliance with the Quality management and GMP standpoint.

• Strong problem solver. Ability to independently communicate and discuss complex Quality topics and regulations with customers.

• Strong Collaboration, Communication skills with mindfulness and empathy.

• Ability to work with people in cross-functional and global with diversity and inclusivity.

• Proficient in MS Office programs. Experience in SAP, Trackwise and Salesforce would be an advantage.