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.
Qualifications
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.
