Manufacturing Compliance Leader
3 weeks ago
The Manufacturing Manager, Manufacturing Compliance is a critical member of our Operations Leadership Team, responsible for ensuring the highest standards of quality, compliance, and efficiency in our biologics manufacturing process.
Key Responsibilities
- Lead teams in Deviations investigations, Corrective and Preventive Actions (CAPA) and Change Controls implementation in the Manufacturing function.
- 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.
- Ensure consistent methodologies are applied to deviations, including compliance with regulatory requirements and Takeda policies/procedures, timely closure, and identification of appropriate corrective actions.
- Contribute to the overall site goals and vision as part of the site's Operational Leadership Team.
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.
What We Offer
At Takeda, we empower our people to shine by providing a stimulating career, encouraging innovation, and striving for excellence in everything we do. Join us and be part of a patient-focused company that transforms patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.
Location
SGP - Singapore - Woodlands
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
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