Johnson & Johnson is on FGB’s Best Companies for Women of 2020.
FGB'ers gave this company a 4.3/5 in overall job satisfaction
FGB’ers working at Johnson & Johnson rated their manager’s support a 4.4/5
Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).
Global exercise reimbursement.
Two weeks off (one of them fully paid) for volunteer work.
Responsible for overall quality oversight and governance for Chinese External Manufacturing Sites, supplying drug products to span of control countries to ensure defect free product supply to market. Ensuring compliance to requirements with applicable regulations, driving and implementing Company’s Quality policies and standards achieving the required business results. Close coordination with business stakeholders such as Supply Chain, Partnership and External Supply (PES), Commercial Quality, Self care Quality, Stability Studies lab, Technical Operations, VCL, Regulatory Affairs to ensure business & compliance goals meet with the expected J&J and regulatory standards. Essential Functions: Direct all of the Quality and Compliance activities of External Manufacturing in the Chinese EM and provide the proper interface to PES and JSC Internal Manufacturing. Interface with the Product Management and Customer Management teams to supply the markets. Conducting investigations, performing customary audits, collecting data, analyzing trends, and preparing reports as required. Travel to External Manufacturer’s sites to provide cGMP assistance and quality oversight. Assess current quality systems and recommend improvements 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. 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. Regional Tasks/Project Support: Cascade global strategic initiatives and drive deployment of Global standards across the External network for EMs. Ensure adequate gap assessments have been conducted and gaps are closed with definite timelines. Responsible to drive, improve and sustain regional compliance initiatives for External manufacturers. Develop, manage and maintain a GxP compliant “Document Management System” to ensure that Source Q&C home office maintains a state of readiness for JJRC inspections. Qualifications Qualification Minimum Qualification Bachelor’s degree in Pharmacy or Pharmaceutical Sciences Experience in External Manufacturing, Technology Transfers, Quality Event Management and Quality Ability to travel a minimum of 30% is required. 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 & Chinese. Other requirements A minimum of 8 years in Pharmaceutical/Medical Device/Biotech is required. Experience in drugs, biologics and medical devices is essential to success. Experience of quality systems of all major regulated markets. Primary Location China-Shaanxi-- Organization Xian-Janssen Pharmaceutical Ltd. (7043) Job Function Quality Requisition ID 2206030530W
Child care benefits
Short term disability