We serve the pharmaceutical companies within the Johnson & Johnson Family of Companies as a center of excellence for pharmaceutical and biologic manufacturing. The JSG governs supply chain organizations with a focus on flawless execution, continuous improvement, and valuing our employees to support JSG vision of “Transforming
Our World: Delivering affordable medicines to anyone, anywhere, any day.”
This position will provide Quality Assurance, Compliance and Technical Support for External Manufacturers in Asia Pacific region
. Providing leadership in the selection, development and management of External Manufacturers in the region.
Providing QA support for technology transfer and improvement of existing manufacturing processes.
Contributing to the overall Global development, implementation and execution of quality systems in support of the manufacture of pharmaceutical products.
Conducting investigations, performing customary audits, collecting data,analyzing trends, and preparing reports as required. Escalating issues as appropriate to Senior Management and supporting the Executive Management Reviews. Working closely with External Supply Integration and other QualityAssurance functions.
Essential Functions
Direct all of the Quality and Compliance activities of External Manufacturing in the APAC Region and provide the proper interface to External Supply Integration and JSC Internal Manufacturing.
Act as senior level interface to key Health Authorities in the region for all of JSC External Manufacturing.
Interface with the Product Management and Customer Management teams to supply the markets.
Assess current quality systems and recommend improvements in order to enhance quality and reduce cycle time
Monitor trends, identify issues, recommend and implement appropriate actions.
Provide cGMP compliance support to External Manufacturers by investigating and resolving quality issues.
Coordinate and provide concurrences on deviations, change controls and CAPAs.
Travel to External Manufacturer’s sites to provide cGMP assistance and quality oversight.
Develop, implement, and review of SOPs for interactions with External Manufacturers.
Investigate customer product quality complaints.
Apply cGMP regulations and other Health Authority and international requirements to all aspects of the position.
Coordinate change control documentation and approval process.
Provide Quality oversight and participate on technical transfer teams.
ADDITIONAL RESPONSIBILITIES/DUTIES:
Provide support to manufacturing / logistics organizations regarding aspects of GMP compliance associated with technology transfer and international manufacturing.
Remain current with international Health Authority regulations, guidelines, and quality practices associated with the pharmaceutical industry is required.
Computer literate well versed in Microsoft Office tools with the ability to communicate effectively electronically.
Fluent in English and Chinese
Continued development of knowledge and expertise as needed in order to perform job duties.
This is not an exhaustive or comprehensive listing of job functions. May perform other duties as assigned.
Qualifications
Minimum Bachelor's Degree Required. Advanced degree (MS, MBA) is preferred. A minimum of 12 years in Pharmaceutical/Medical Device/Biotech is required.
Experience in drugs, biologics and medical devices is essential to success.
Experience in External Manufacturing, Technology Transfers, Quality Event Management and Quality System Development is required. Experience in presenting issues to all levels of the organization is required.
Ability to develop Quality Systems and provide cGMP compliance support to External Manufacturers is required.
Demonstrated experience with all dosage forms is preferred. Experience investigating customer Product Quality
Complaints is preferred. Proficiency in computer applications such as the MS Office suite is preferred.
Demonstrates refined skills in the following Global Leadership areas: Integrity and Credo-based Actions; Strategic Thinking;
Big Picture Orientation with Attention to Detail; Intellectual Curiosity; Collaboration and Teaming; Sense of Urgency;
Prudent Risk-taking; Self-awareness and Adaptability; Results and Performance Driven. Ability to travel a minimum of
30% is required.
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