This position is required to lead the Quality Assurance Department (QAD) team, which includes Quality Assurance, Quality Operations and Quality Excellence sections to achieve the site objectives for Takeda Manufacturing Singapore.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Discover more at takedajobs.com.
Quality and Technical Guidance
- Lead the QA team in ensuring that an effective Quality Assurance 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.
- Proactively monitor sources of trends, complaints, failures, deviations and changes to identify opportunities for system, process and product improvements.
- Support the compliance, regulatory and training activities as required and any other responsibilities as assigned by Site Quality Head.
- Determining decisions on bulk drug substances.
- Review and approve major and significant NCR/exception/ investigation reports.
- Manage, coach and develop QA team and contribute to growth of team members.
- Define and drive strategies, priorities and compliance standards across the areas of accountability.
- Liaise with Quality counterparts at other Takeda sites for information learning and sharing and alignment of best practices.
- Ensure succession planning by identifying and grooming high potential employees to be successors for QA manager and supervisor roles to ensure business continuity.
- Strengthen relationship with manufacturing to ensure open communications and acceptance.
- Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda's Code of Conduct.
- Serves as a delegate for Site Quality Head in his/her absence and approve any QA related documents.
EHS and Other
- Responsibility to adhere to any applicable EHS requirements.
- Any other duties as assigned by supervisor.
Education and Experience Requirements
- 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.
- Minimum experience of 10 years, with 5 years of supervisory position, in the pharmaceutical or biotechnology in quality assurance, GMP/GLP 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.
- Ability to collaborate cross functionally and cross sites.
- Good decision making capability.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.