Quality Assurance Manager

6 days ago

Singapore SCG CELL THERAPY PTE. LTD. Full time

**Quality Assurance Manager
SCG Cell Therapy Pte Ltd is a clinical-stage biotechnology company focusing on the development of novel immunotherapies for patients with pathogenic infections and it associated cancers. Our strategy is to harness patient's immune system by redirecting cellular responses toward pathogens and its associated cancer using adoptive cell therapy, bispecific antibodies and vaccines.

**Key Responsibilities**

Reporting to the Head of Operations, the QA Manager will be responsible for daily quality Assurance activities and ensure all activities are according to SOP and GMP requirements including management of external manufacturing and testing labs.
- Perform or support cGMP lot release, in-process, and stability testing using flow cytometry.
- Ensure timely completion of testing and tasks as assigned.
- Perform assay and form review.
- Execute technical transfer and validation protocols for QC assays.
- Assist in the implementation of new assay methodologies and the associated instrumentation.
- Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner.
- Identify and support initiation and completion of Deviations, CAPAs and Laboratory Investigations.
- Identify and facilitate continuous improvements.
- Participate in cross-functional training.

**Requirements**:

- Minimum Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or related life Sciences or Technology with about 8-10 years of experience in Quality Assurance role in the pharmaceutical / biotechnology industry.
- Knowledge of regulations and standards of the pharmaceutical industry
- Demonstrated experience in developing a Pharmaceutical Quality System (PQS)
- Experience of writing and/or review of GxP documents to ensure good documentation, data integrity, GxP and regulatory requirements are met
- Direct experience with lot disposition supporting the manufacturing, testing, disposition, and distribution of cGMP products.
- Knowledgeable of FDA regulations and ICH Guidelines regarding the manufacture of biological including regulatory inspection experience.
- Effective problem-solving skills and good understanding of risk-based decision framework
- Experience with Cell/Gene Therapy preferred
- Knowledge and experience in Cleanroom Qualification and Environmental Monitoring preferred.

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