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Jobs or company...

Manager QA & Regulatory Compliance

Salary undisclosed
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Role Purpose

We are seeking a Manager QA and Regulatory Compliance who will oversee all aspects of quality for our Singapore laboratories. This role involves defining a risk-based quality strategy and implementing the QA programme to verify that the studies and test facility comply with OECD GLP and other applicable guidelines.

Key Responsibilities
  • Coordinate audits and inspections from external parties/conformity assessment bodies (e.g. clients, GLP monitoring authorities)
  • Monitor the implementation of the QA programme, including verification of the study plan, inspection of the final study report and QA inspections.
  • Provide quality oversight of suppliers and contract laboratories.
  • Oversee the maintenance and implementation of the QMS, ensuring alignment at the local and global level.
  • Manage the QA review of QMS documents, computerised systems and equipment documentation to assure that procedures and equipment are suitable for their intended purposes.
  • Oversee the QMS document, training, GLP archives and GLP compliance training programme.
  • Oversee the facility's NC, CAPA and Change management programme and monitor quality KPIs.
  • Lead and develop the QA team, providing ongoing training and education.
  • Collaborate across departments to achieve quality targets and foster a quality mindset.

Skills Required
  • Bachelor's degree in a scientific discipline, MS or equivalent preferred.
  • At least 10 years of related experience in a pharmaceutical/biologics/biotechnology company.
  • More than 10 years of ISO, GLP, or GxP working experience.
  • Knowledge of regulatory requirements, GLP, FDA, ICH, GCP, GxP, and industry practices.
  • Advanced knowledge of OECD GLP principles and other quality systems.

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