Head of Quality Assurance

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Job Description

Takedas Singapore biologics manufacturing facility focuses on manufacturing potentially life-saving medicines for patients suffering from rare blood disorders such as Hemophilia A and B. As part of the companys Biologics Operating Unit network the site is Takedas only biologics drug substance manufacturing facility in Asia. The facility has two buildings including manufacturing suites and laboratories as well as Takedas first positive energy building certified by Singapores Building and Construction Authoritys Green Mark scheme in 2022.

Location: Woodlands Singapore

About the role: The Head of QA is responsible for ensuring the quality of processes and product outputs. This role involves defining activities processes and standards to meet quality requirements auditing and monitoring processes and ensuring compliance with corporate and customer quality standards. By maintaining high-quality standards this role supports Takedas mission to bring better health to people and a brighter future to the world.

This position is required to lead the Quality Assurance (QA) Department which includes Quality Assurance Support Suite 1 Quality Operation Suite 2 Quality Operation and Quality Excellence teams to achieve the site objectives for Takeda Singapore.

How you will contribute:

Quality and Technical Guidance

• Lead QA team to ensure robust quality oversight and compliance with regulatory corporate and divisional standards.

• Drive implementation of quality management systems and compliance standards

• Provide leadership and technical support for all GMP/quality activities while fostering a culture of continuous improvement in quality operations

Operations

Lead decisions on quality operation quality risk management and product disposition.

Review and approve deviation investigation and CAPA reports.

Coordinate communication and collaboration with local and global functions.

Own manage and control QA budget planning forecast and execution including OpEx Capex and continuous improvement projects.

Leadership

• Lead coach and develop QA team ensuring succession planning.

• Lead and drive QA operational strategies.

• Collaborate with quality counterparts across sites and build strong relationships with manufacturing for alignment and best practices.

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 a related discipline.

Certification and trainings such as auditor training or QP training will be advantageous.

A minimum experience of 10 years with 5 years of supervisory position in the pharmaceutical or biotechnology in quality assurance GMP compliance operations or validation ideally in a multinational company.

FDA/EU cGMP know-how and a thorough understanding of ICH guidelines together with exposure to the international regulatory network.

Serve as a delegate for Site Quality Head in his/her absence

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.

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