Mgr,Qaulity-Regulatory ComplianceReq # JR - 025551 Location Shanghai, Shanghai Municipality, China Job Category Quality Control Date posted 08/11/2020
Are you looking for a career that matters?
We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.
Learn more about how Baxter is At the Intersection of Saving and Sustaining Lives.
Essential Duties and Responsibilities
Product Post-marketing Management
Field Action (called as recall in below) handling.
- Receives recall decision from AP, determine if China is impacted or not with the support from sub entity;
- Participate in China Recall Strategy team;
- Follow up issue escalation, till the decision is made;
- Follow up recall execution and implementation until closure if China is impacted;
- Works as subject matter expert of recall, supervise recall handling, ensure Baxter requirement and China regulations are complied
- Tracking GXP/testing impacted regulatory change in China level
- Coordinate regulatory change related implementation in China sub entities.
- Regular communicate the
- Manage the routine communication with authorities which include NIFDC, CHP committee, CCD and NMPA product safety supervision departments.
- Working as Quality Representative in External Collaboration Projects.
- Tracking the industry best practice for benchmarking.
- China GQP owner for regulatory intelligence
Quality System Management:
- Make sure global QMS documents implementation in greater China in a timely and compliance manner.
- Support China manufacturing plants on some critical investigations and EU GMP guideline related gap analysis and mitigation action implementation as technical support.
- Excellent communication skills with all relevant stakeholders for both external government agency and internal company
- Expertise in China GMP/GSP regulations and EU GMP, ISO 13485, MDR, ect.
- Strong teamwork spirits; Remote people management skill;
- Able to analysis and solve problems independently and innovatively;
- Proficiency in MS office;
- Excellent communication skills in both written and verbal English.
- Bachelor degree major in pharmaceuticals, chemistry or related;
- 5 years working experience in pharmaceutical quality, 2 to 3 year in management position;
- Experience in Drug and Medical Device Quality Management in multinational company
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.