HireDiversity

Beijing, CN

Manager QA-000005VR

Description

Ø Evaluation, development and management of quality systems at the third-party manufacturers (API, GMP intermediates and GMP starting materials) and commodity API, excipient and Bio-material manufacturers by conducting audits, by performance monitoring and implementing development programs and by installing quality agreements

Ø Coordinate Quality Project summaries and Project review within Janssen Supply Chain.

Ø Responsible and accountable for the quality of products produced by third-party manufacturers (API, GMP intermediates and GMP starting materials) and commodity API, excipient and Bio-materials manufacturers (including change management, deviation and complaints handling, validation)

Ø Handles issues, by personal intervention and /or appropriate delegation within the organization to drive to resolution. Fields actions, recalls, compliance audit observations etc may be among the escalated topics that require his/her involvement

Ø Effectuates and permanently maintains inspection readiness at the third-party manufacturers (API, GMP intermediates and GMP starting materials) and commodity API, Excipient and Bio-materials manufacturers. Supporting of third-party manufacturers and API suppliers during regulatory inspections and audits and during the development of corrective action plans

Qualifications


Ø In-depth knowledge of cGMP and other applicable regulations of the different regulatory authorities (for API as well as Excipient and Bio-Materials)

Ø Working knowledge of analytical chemistry, microbiological test methods , chemical processes as well as Bio-material manufacturing processes. Able to apply this knowledge in combination with quality system requirements to evaluate and (if applicable) to lead the development of quality systems at the different third-party manufacturers

Ø Clear, specific and concise verbal and written communication skills.

Ø Ability to build up interdependent partnerships with excellent interpersonal interaction skills particularly the ability to interface with multiple non-J&J business partners and in some instances influence without direct authority. Strong people leadership and development track record. Ability to work effectively across many different cultures and geographical regions.

Ø Demonstrates strong knowledge of Quality Management competencies such as auditing, quality engineering, root cause analysis, FMEA, design control, project management , specification and stability management

Ø Ability to assess and manage risks in a prudent manner, sound decision making and problem solving expertise. He/she must be able to understand the circumstances to determine which critical support functions must be consulted prior to final decision and disposition. As most of the decisions are not standard, he/she must rely upon their experience, business knowledge and key technical collaboration.

Ø Ability to balance multiple tasks, objectives and priorities.

Ø Cost sensitive in managing own expenses and finding the 'right balance' between Q&C needs and effective implementation costs for the quality development of the third-party manufacturer.

Ø Proven leadership and people management skills. Potential to grow to a people management role in the future.

Primary Location:Asia Pacific-China-Beijing-Beijing
Other Locations:Asia Pacific-China-Shanghai-Shanghai
Organization: Xian-Janssen Pharmaceutical Ltd. (7043)
Job Function: Quality (Eng)