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Job Description

Company Profile:

Takeda's 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 company’s Biologics Operating Unit network, the site is Takeda’s only biologics drug substance manufacturing facility in Asia. The facility has two buildings, including manufacturing suites and laboratories, as well as Takeda’s first positive energy building certified by Singapore’s Building and Construction Authority’s Green Mark scheme in 2022.

Job Title: Head of Quality Assurance

Location: Woodlands, Singapore

About the role:

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 the QA team in ensuring that an effective QA oversight is provided to the site.
• Provide leadership and technical support for all GMP/quality activities for manufacturing and other assigned areas of responsibility
• Lead the QA team to establish, disseminate and monitor the implementation of appropriate quality systems and compliance standards for the site according to regulatory, corporate and division requirements.
• Responsible for ensuring that product quality issues are correctly investigated, and that appropriate corrective and preventative actions are implemented.
• Support the compliance, regulatory and training activities as required and any other responsibilities as assigned by Site Quality Head

Operations

• Determining decisions on bulk drug substances.
• Review and approve major and significant NCR/exception/ investigation reports.
• Coordinate communication and collaboration with above-site functions, and not limited to GQ functions, Manufacturing Sciences, Global Supply Chain and Global Regulatory Affairs.
• Manage and control QA budget planning, forecast and execution, including OpEx, Capex and continuous improvement projects.

Leadership

• Manage, coach and develop QA team and contribute to the growth of those professionals.
• Drive and define strategies, priorities and compliance standards across the areas of accountability.
• Liaise with quality counterpart from other Takeda sites for information learning & sharing and alignment of best practices
• Ensure succession planning by identifying and groom high potential employee to be the successor for the QA AD and supervisors to ensure business continuity
• Build strong relationship with manufacturing to ensure open communications and acceptance

Other responsibilities

• 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 a related discipline. Additional 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.
• Able to logically solve problems in order to find timely solutions.
• An ability to interact and communicate with all types of personalities in an effective and diplomatic manner
• Good decision-making capability

Key Skills and Competencies

• Good knowledge in the various regulatory requirements

• Serves as a delegate for Site Quality Head in his/her absence and approve any Quality related documents.

• Ability to collaborate cross functionally and cross sites

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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