Manufacturing Manager, Manufacturing Compliance

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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: Manufacturing Manager, Manufacturing Compliance
Location: Woodlands, Singapore

About the role:

The Manufacturing Manager, Manufacturing Compliance is responsible for leading teams in Deviations investigations, Corrective and Preventive Actions (CAPA) and Change Controls implementation in the Manufacturing function.

The individual will participate in or support root cause analyses, CAPAs, & Change Controls implementation in response to investigational findings, improvement initiatives, and/or compliance gaps to ensure product quality and on-time batch delivery. The individual will ensure consistent methodologies are applied to deviations, including compliance with regulatory requirements and Takeda policies/procedures, timely closure, and identification of appropriate corrective actions.

As part of the site’s Operational Leadership Team, the individual will also contribute to the overall site goals and vision.

How you will contribute:

Team Management and Development

• Motivate and support the career development and technical expertise of staff and communicate company policies/goals/strategies/business results.

• Coach and guide team members in the writing of deviation investigations, CAPAs and change controls.

• Plan resource requirements, delegate appropriately, and assure staff members are productive and work is focused / aligned with company and departmental objectives.

• Foster teamwork and drive process improvement.

• Effectively communicate ideas, team priorities, and results.

Deviation Investigation Management

• Analyze investigations and ensure quality of written records; technically sound root cause analysis and product impact assessment; identification of appropriate corrective actions; timely closure.

• Keep abreast of knowledge in current industry best practices related to root cause analysis and human performance; promote implementation at Takeda as applicable.

CAPA and Change Controls Implementation

• Ensure timely execution of Corrective and Preventive Actions (CAPAs) and Change Controls.

Inspection Readiness and Support

• Ensure deviation records are always compliant and in a state of inspection readiness.

• Prepare SMEs for and present investigations during regulatory inspections and audits.

Prepare responses for audit observations.

Business Oversight

• Drive team to meet defined metrics through the utilization of visual management boards.

• Participate in system improvements and optimization efforts to improve the output and throughput of various systems / processes.

• Ensure adherence to assigned cGMP training requirements, including team’s on-time completion of mandatory trainings.

• Manage department budget to meet budgetary targets.

Others

• 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:

• Bachelor’s degree or equivalent experience in Engineering or Science and 7 years of relevant experience in commercial biotechnology or pharmaceutical production.

• Diploma in Applied Chemistry / Biomedical Sciences / Chemical Engineering / Food Science & Technology / Biologics & Process Technology / Chemical & Pharmaceutical Technology/ Food Science & Nutrition / Molecular Biotechnology / Biotechnology / Chemical & Biomolecular Engineering / Pharmacy Science or equivalent and possesses minimally 9 years of relevant experience in the biotechnology or pharmaceutical industry.

• Nitec in Biotechnology / Chemical Process Technology or equivalent with minimally 12 years of relevant experience in the biotechnology, pharmaceutical industry

• Prior experience investigating complex deviations is required. 

• Strong knowledge of formal root cause analysis tools.

• Knowledge of cGMP and other regulatory requirements related to manufacturing of biologics.

Key Skills and Competencies:

• Must possess knowledge of cGMP, commercial operations, and root cause analysis tools.

• Excellent verbal and written communication skills, including demonstrated ability to effectively present to senior management and regulatory inspectors.

• Organizational effectiveness and employee development focus

• Customer service oriented

• Ability to foster environment of learning and continuous improvement.

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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