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Job Description

Job Title: Quality Excellence Supervisor

Location: Woodlands, Singapore

About the role:

This position is required to lead the Quality Excellence team responsible for the execution activities related to the deviation and change control quality system to achieve the site objectives and compliance for Takeda Singapore.

How you will contribute

• Operationso 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.o Lead the team to ensure timely review and approval of investigations to support release of BDS and raw material.o 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.o Lead the team to ensure timely review and approval of investigation in the event of customer complaints and product recall.o Facilitate and lead quality process such as daily deviation tracking to provide guidance and drive deviation investigation progress and closures.o Support and lead the reporting of deviation-related metrics.o Lead and participate in improvement initiatives within Quality Team.o 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

• Leadershipo Manage, coach and develop Quality Excellence specialists and contribute to the growth of those professionals.o Ensure succession planning by identifying and grooming high potential employee to be the successor for the supervisor role to ensure business continuity.o 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.

What you bring to Takeda:

Education and Experience Requirements

• 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.

Key Skills and Competencies

• Equip with good knowledge of quality systems.

• Equip with good knowledge in the various regulatory requirements.

• Equip with good presentation skills.

• Able to solve problems in a logical manner with timely solutions.

• Able to interact and communicate with all types of personalities in an effective and diplomatic manner.

• Project management skills is preferred.

• Product release knowledge is preferred.

• Be a delegate for QA line manager in his/her absence and approve any QA related documents.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

Locations

SGP - Singapore - Woodlands

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time