岗位职责：
1. Implemention and oversight of a Quality Management System that operates in compliance with corporate quality polices and procedures, and relevant regulatory requirements and industry guidance, including:
- Implementation of document control and review/approval of controlled documents
- Implementation of change management and review of all change controls
- Implementation of supplier quality management and performance of supplier audits as appropriate
- Complaint management including robust root cause analysis and CAPA
- Implementation of an effective Internal Audit Program
- Ensure adequate Training Program is in place
- Implementation of applicable Validation Master Plans including equipment, process, product, sterilization and test methods
- Implementation/oversight of quality control laboratory and review/approval of QC testing
- Oversight of cleanroom practices including qualification, monitoring and behavior
- Oversight of sterilization programme
- Implementation of Quality Risk Management in relevant aspects of the QMS
2. Perform Quality Review of batch documentation and testing and determine disposition for all production batches and incoming raw materials. Ensure robust root cause analysis investigation and CAPA for deviations and nonconforming product(NCM).
3. Customer Management and Maintain QMS, including:
- Facilitate/host customer audits
- Ensure robust and effective corrective action to customer audit observations.
- Review/approve Quality Agreements with customers
- Partner in the resolution of Quality Issues and requests for information by initiating effective interdepartmental communication.
- Maintain QMS, Manage ISO Certification & Maintenance of certification.
- Facilitate/host regulatory agency audits
4.Execute talent management activites with direct reports, if applicable. Ensure proper performance management, training, and development of direct reports.
5. Facilitate Management Review process including implementation of a metrics control plan to measure and monitor the health of the Quality Management System, Manufacturing System, and Supply Chain.
6. Other duties as assigned and/or contained in annual goals and objectives.
7. Responsible for compliance requirements of reviewing product.
EHS related responsibility：
1. Total comply with local regulations & laws and follow site EHS procedures /rules.
2. Attend EHS training, participate in site EHS activities and promote EHS requirements.
任职要求：
1. Bachelor’s Degree – Life Sciences or Chemistry, biology, microbiology.
2. Minimum of eight (8) years of experience in a regulated industry with preferred emphasis in life sciences (e.g. pharma, biopharm, or medical device with cleanroom/sterile products preferred).
3. Minimum six (6) years in a Quality function with at least 3 years in a Quality System design, development, and implementation and supervisory role.
4. Experience in people management and development.
5. Strong knowledge of ISO13485, QSR820 and cGMP requirements and relevant industry standard practices is required. Must have ability to interpret these regulations to ensure proper implementation in the plant systems.
6. Must have experience in performing risk analysis. (e.g. FMEA, FTA, Risk Ranking/Filtering)
7. Demonstrated understanding of Lean Manufacturing concepts preferred.
8. Strong project management skills preferred.
9. Strong computer skills required including Microsoft Word, Excel, Visio, PPT, and Project.
10. Must work well in a team environment, possess an ability to adapt to change in the environment, and have proven ability to exert influence in a directive and positive manner.
11. Must be able to lead, manage, and motivate a team through direct management or matrix management.
12. Must possess excellent verbal and written communication skills both in Chinese and English.