Quality Systems Supervisor

Job Description

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Job Description

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: Quality Systems Supervisor
Location: Woodlands, Singapore

About the role:

This position is part of the Quality Systems team responsible for implementation and maintenance of the various Quality Systems and to guarantee the quality oversight of supplier management and material management (includes material qualifications) as well as all the validation related activities which includes Data Integrity at site.

How you will contribute:

Quality Systems implementation and maintenance:

• Support the quality system team to establish, disseminate and monitor the implementation of appropriate quality systems and compliance standards for the site according to regulatory and global requirements.
  • Change control management
  • Documentation management
  • Investigation program management
  • Annual product review management
  • Quality Improvement System
  • IT Systems Quality
• Support on the oversight and approval of GMP curricula
• Support on the oversight of the Integration Program. To support on the gap analysis for local procedure with collaboration with subject matter experts in compliance with global procedure and ensure that an implementation is in place and track for completion.
• Responsible to oversight the Quality Validation.
• Responsible to oversight the training program as the Training Coordinator
• Responsible to review and approve validation protocols, reports, procedures and other related documents including Quality Control related (Analytical Instrument Qualification, Analytical and Microbiology Method Validation, Critical Reagent Qualification) to ensure compliance to internal procedures and regulatory requirements.
• Evaluate and approve discrepancies related to qualification/ validation protocols in order to guarantee documentation of the incidents and identification of corrective actions.
• Collaboration and participations in projects as Quality Representative for Quality Systems and Validation including Quality Control related.
• Provide validation expertise and support for the development (or modification phases) of manufacturing facility, systems, process, Computerized System and Quality Control related (Analytical Instrument Qualification, Analytical and Microbiology Method Validation, Critical Reagent Qualification).
• Support Data Integrity meeting for strategy, assessment and remediations with process owners, system owners and DI extended team. Evaluate and approve Data Integrity related documents.
• Participation in internal and external audit as required.
• Responsible to oversight and lead the site Change Control Review Board (CRB), evaluate the change control requests, and provide support in the review of the associated risk assessment.
• Provide qualification/ validation related impact assessments for change control.
• Support and oversight on Supplier Quality Management (Supplier Complaints, Supplier Notification of Change, Quality Agreement, Supplier Monitoring, and SMS Trackwise System)
• Support and oversight on Material Management (Specification, Implementation which includes Material Qualification, Impact Assessment, Complaints, and support activities in regulatory, product) Process
• Responsible to review and approve the Material Qualification protocols, reports, procedures, and other related documents to ensure compliance to internal procedures and regulatory requirement.
• Ensuring the information contained in approved validation document(s) is understandable and defendable during inspection.
• Provide quality oversight on the validation maintenance activities including Quality Control related (Analytical Instrument Qualification, Analytical and Microbiology Method Validation, Critical Reagent Qualification).
• Approving the Master Validation Plan.
• Participate in multisite initiatives to ensure harmonization of Quality Systems and qualification/ validation related activities between the plants.
• Manages coaching, training and development for the team.
• Ensure succession planning by identifying and groom high potential employee to be successor for the Quality Systems Supervisor role to ensure business continuity.
• Build strong partnership with all other departments to ensure open communications and acceptance
• 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 5 years in pharmaceutical or biotechnology in quality assurance, GMP/GLP compliance, operations or validation, ideally in a multinational company.
• Understanding of FDA/EU cGMP and ICH guidelines, any exposure/experience to the international regulatory network/audits will be advantages.

Key Skills and Competencies

• Demonstrated ability to collaborate with cross functional or cross sites to achieve objectives.
• Able to logically solve problems in order to find timely solutions.
• Ability to handle complex validation discrepancy, supplier and material complaints.
• Good Verbal and written communication.
• Critical thinking and demonstrated problem solving skills.
• Deep knowledge of regulations and a thorough understanding of ICH guidelines and the various validation guides such as PDA Technical guides, ISPE GAMP guides etc.
• Ability to lead / support CAPA investigation.
• Ability to provide coaching to others.
• Communication skills and organization skills.

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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