Quality Assurance – Manager

Job Location(s):
Suzhou, China

Job Location(s):

工作地点

Function: 

Regulatory Affairs

Primary Function:

The QA manager will be a member of the QA team, who will provide support to develop, review and approve SOPs; manage the quality systems; QA support for CMOs/CROs/CTOs activities; and internal GMP facility certification.

Major Responsibilities and Duties:

  • Support the established Quality Management System (QMS); develop, review, and approve SOPs; and maintain quality systems.
  • CDMO/CRO/CTO management including Quality Agreement, material management, manufacturing process quality, packaging, distribution and product release etc.
  • Plan, lead and support investigations, complaints, change controls, and CAPAs,
  • Supports development and approval of specifications, test methods, SOPs, and master batch records.
  • Develops, implements, and maintains compliant GMP Quality Management Systems and applicable regulatory requirements.
  • Supports timely release and distribution of products from outsourced manufacturing, testing, and distribution operations.
  • Partners closely with CDMO/CRO/CTO to manage third party contractors. On-site quality monitor if needed.
  • Works with key stakeholders and CDMO/CRO/CTO to ensure timely closure of investigations, complaints, and change controls.
  • Internal audits and external audits of contract laboratories, CMOs, distribution centers, and suppliers as required; and management of inspections by regulatory agencies.
  • Support project team on quality and regulatory compliance, interact with external agencies for information update, routine communication, issue resolution etc.
  • Support internal GMP facility certification.
  • Quality related training plan, implementation, and tracking.
  • Other assigned works.

Qualifications:

  • Minimum B.S., B.A or equivalent in a scientific discipline and equivalent experience in pharmaceutical quality.
  • About 3-5 years of experience in a quality assurance function.
  • Familiar with U. S. and China regulatory requirements about medical device or pharmaceutical (GMP, GDP, etc.).
  • Demonstrates good verbal, written and interpersonal communication skills in both Chinese and English.
  • CDMO management experience will be better.
  • QMS establish and maintain experience (focus on medical device) will be preferred.