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Quality Excellence Supervisor

Full-Time Singapore, Singapore
Health & Biotech
Health & Biotech
26 June 2024
  • Operations
  • Lead a team of Quality Excellence Specialists to support site investigations relating to Manufacturing/ Engineering/ Validation/ Logistics/ Supply Chain Planning/ Laboratories/ Incoming Material Release and review/approve the investigation report.
  • Lead the team to ensure timely review and approval of investigations to support release of BDS and raw material.
  • Lead the team to ensure timely review and approval of change controls to support implementation of changes with exceptions to raw material, computer system validations and new equipment.
  • Lead the team to ensure timely review and approval of investigation in the event of customer complaints and product recall.
  • Facilitate and lead quality process such as daily deviation tracking to provide guidance and drive deviation investigation progress and closures.
  • Support and lead the reporting of deviation-related metrics.
  • Lead and participate in improvement initiatives within Quality Team.
  • Participate and lead in any corporate/division alignment meetings for information learning & sharing and alignment of best practices.
  • Participate and lead in quality system(s) rollout by ensuring that the elements of the assigned quality system(s) is/ are implemented and maintained at the site according to regulatory, corporate and division requirements for deviation and change control management systems.
  • Support the compliance, audit, regulatory and training activities as required, and any other responsibilities as assigned by Supervisor
  • Leadership
  • Manage, coach and develop Quality Excellence specialists and contribute to the growth of those professionals.
  • Ensure succession planning by identifying and grooming high potential employee to be the successor for the supervisor role to ensure business continuity.
  • Build strong partnership with all other departments to ensure open communications and acceptance.
  • Responsibility to adhere to any applicable EHS requirements.
  • Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda’s Code of Conduct.
  • Any other duties as assigned by supervisor.
  • The candidate should have at least a degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, or related discipline.
  • A minimum experience of 7 years (with at least 3 years in senior position) in the pharmaceutical or biotechnology in quality assurance, GMP/GLP compliance, operations or validation, ideally in a multinational company.
  • Understanding of FDA/EU and ICH guidelines and any exposure/experience to the international regulatory network/audits will be of advantage.
  • Six sigma greenbelt certification would be of advantage.


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