Quality Manager, Global Compliance
You will be a key part of the team that drives the agenda of Global Quality Compliance ensuring that our Quality Management System is maintained on-time with the most updated regulations but importantly providing oversight of my clients Infant Formula Children Nutrition standards. The Global Quality Compliance Manager acts as GMP expert for Infant Nutrition on regulations and drives regulatory compliance working closely with Regulatory Affairs and act as voice for Quality Assurance. The purpose of the role is to deploy Infant Nutrition Quality standards to global sites, drive compliance and quality performance, by implementing and maintaining Corporate Quality Management System and Quality compliance programs.
Scope:
- Actively help to formulate and lead Global Quality Compliance and Performance Strategy. Once the strategy is formulated, drive update of standards to ensure global consistency across the business
- Draft, update and maintain IFCN HPRs and relevant SOPs ensuring that the Standards are self-explanatory and not open for interpretation in the sites. Coordinate HPR 2.0 with full linkage with SAMR
- Provide SME support to Global Quality System and maintain cluster Global SOPs
- Create internal cross audit system, SOP and internal auditor training to calibrate regulatory
- interpretations in Sites
- Support Sites for audit technical readiness providing tools as self-explanatory as possible
- Prepare deployment, metrics design and work with sites for reporting. Prepare management reporting and quarterly management review meeting
- Conduct site visits to support as appropriate, implementation of standards, compliance and site quality culture pulse checks
- Able to lead on improvement plans, requires a good manufacturing knowledge and an
- understanding of business processes.
Technical\professional qualifications required:
- At least BSc degree in Life Sciences
- At least 5 years of working experience in China within quality and/or regulatory compliance function
- Infant Formula background strongly desired. Experience in Pharma industry is a plus
- Must have factory quality operation experience and strong technical problem solving
- Broad knowledge of China GB Standards and GMP Regulations
- Proven experience in critically reviewing detailed regulatory changes
- Direct experience in FSSC 22.000 is a plus
- Experience in developing and maintaining a robust QMS including deep knowledge of HACCP
- Able to lead on improvement plans, requires a good manufacturing knowledge and an understanding of business processes.
Please send your resume in WORD format by clicking the apply button below or contact Jochen Surrey on +65 6701 1516 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1878834 (Jochen Nico Surrey).
