Head of Quality Assurance

Takeda; Singapore; On-site; SGD 120,000 - 150,000; Full time

Job summary

A leading biotechnology company in Singapore is seeking a Head of QA to ensure high quality standards and compliance with regulations. The ideal candidate will have a degree in relevant sciences, at least 10 years of experience in quality assurance including 5 years in a supervisory role, and strong problem-solving skills. Responsibilities include leading a QA team, managing the QA budget, and collaborating with cross-functional teams. This full-time position offers the opportunity to drive quality initiatives in a multinational environment.

Qualifications

• At least 10 years experience in QA, including 5 years in supervisory positions.
• Familiarity with FDA/EU cGMP and ICH guidelines.
• Ability to interact and communicate effectively with diverse personalities.

Responsibilities

• Lead the QA team in providing effective oversight and support for GMP activities.
• Manage QA budget planning and execution.
• Ensure product quality issues are investigated and addressed.

Skills

Regulatory knowledge

Problem-solving skills

Decision-making capability

Collaboration skills

Education

Degree in pharmaceutical sciences or related discipline

Job description

Job Description

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 Takeda's mission to bring better health to people and a brighter future to the world.

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 grooming 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.

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 training 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.

Locations

SGP - Singapore - Woodlands

Worker Type

Employee

Worker Sub‑Type

Regular

Time Type

Full time