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Sr Quality Manager

Req #: 180002LP_en
Location: Shanghai, 31 CN
Job Category: Quality
Date Posted: 2/26/2018 4:49:07 AM
Baxter International


About Baxter

Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anaesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.


What You’ll Be Doing

It’s impossible to list everything you’ll do here because every day is different. But a few things are clear, you’ll:

- To be as a quality management representative in China Trading company & TSC, to implement the quality systems procedures and compliance with Global Standard and requirements

- Ensure the China Trading Quality Management system comply with China authority regulatory requirements and maintain Medical Device Distribution License.

- Communications with BU and other function team about the vision, strategy, and direction for quality objective.

- Motivate, train and counsel subordinates.

- Report and communicate Medical Device MDR with authority, BU and abroad facility, annual analysis and summery to authority,  handle authority query if necessary 

- Delivery FCA information in Greater China, implement FCA in Shanghai Trading, communicate with authority in each Shanghai Trading FCA case. Support FCA evaluation in China manufacturing site.

- Support continuous improvement/ China local innovation projects with the objective of achieving quality, reliability and cost improvements.

-Tracking, Understands and assures conformance to regulations. Interface the authority in significant quality case. Manage external and internal audit/GC audit/internal assessment.

- Keep communication with China and abroad manufacturing plant on new/update regulation, tracking gap analysis and the action conduct in each relevant site.

- Works with and supports the activities within the manufacturing in quality regulatory compliance issue, keep in touch with pharmaceutical industry associations and share good practice with manufacturing plants.

- Establish and manage an internal quality assessment program to audit all operations under control and verify the effective implementation of Baxter Quality Management System.

- Support and participant Global and AP Quality project and implement in Greater China level.

- Work with AP supplier management team, co-ordinate Greater China supplier management resource and tracking the progress

- Work with AP quality system team and manage local SME to build up pipeline of different quality topic.

- Develops budget for a section or department and ensures adherence to the budget.

- Commit to EHS regulatory compliance for the operation of the department and promote the importance of EHS requirements for the effective and efficient operation of the department


Do you have what takes to build a career here?


1.    Well versed with the regulatory requirements such as GMP requirements; medical device GSP requirements; regulatory requirements for drugs, and devices in the China.

2.    Mature, confident, possess high analytical ability and problem solving skills.

3.    Leadership skills and ability to manage/supervise a team of employees.

4.    Bachelor degree in medicine or related fields or have intermedium professional and technical titles or have pharmacist license;

5.    At least 10 years’ experience in quality management.  Medical device GSP experience is preferred


Why Baxter?

A Career That Matters

Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.

Apply today and experience a career that matters!

Baxter is an equal opportunity employer and makes employment decisions without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other status protected by law.

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