Head of Quality Assurance

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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 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

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.

• 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