Quality Assurance Manager

1 day 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.

  • Quality Assurance Manager

    2 weeks ago

    Singapore Cordlife Singapore Full time

    Get AI-powered advice on this job and more exclusive features. Job Summary: The QA Manager is responsible for ensuring the quality and safety of cord blood processing, storage, and release, in accordance with relevant regulatory and accreditation bodies including AABB, FACT, CAP, and HSCA (MOH). This role includes implementing quality management systems,...

  • Quality Assurance Manager

    2 days ago

    Singapore Cordlife Singapore Full time

    Get AI-powered advice on this job and more exclusive features. Job Summary: The QA Manager is responsible for ensuring the quality and safety of cord blood processing, storage, and release, in accordance with relevant regulatory and accreditation bodies including AABB, FACT, CAP, and HSCA (MOH). This role includes implementing quality management systems,...

  • Quality Assurance Manager

    2 weeks ago

    Singapore Hartmann Young Full time

    Recruitment Director in Nutraceuticals & Ingredients | Women in Nutraceuticals – UK Sub-Chair | Building Diverse Teams that Drive Innovation As Quality Assurance Manager, you will oversee and implement quality management systems to ensure compliance, product integrity, and regulatory alignment across the company’s APAC operations. This role requires a...

  • Quality Assurance Manager

    2 days ago

    Singapore Hartmann Young Full time

    Recruitment Director in Nutraceuticals & Ingredients | Women in Nutraceuticals – UK Sub-Chair | Building Diverse Teams that Drive Innovation As Quality Assurance Manager, you will oversee and implement quality management systems to ensure compliance, product integrity, and regulatory alignment across the company's APAC operations. This role requires a...

  • Quality Assurance

    5 days ago

    Singapore Eternaindonesia Full time

    Eterna Indonesia is a leader in technology development with a special focus on pioneering web and software solutions. Our commitment to innovation and excellence motivates us to grow our team. We are currently seeking a highly skilled and motivated QA to manage our CRM project for solar energy initiatives and ensure the highest quality standards. Role...

  • Quality Assurance Manager

    7 days ago

    Singapore Survitec Group Limited Full time

    **Vacancy Title**:Quality Assurance Manager** **Vacancy Location: Senoko, Singapore** **Engagement Type: Permanent, Full Time** **The Role**: Here at Survitec, we are currently recruiting for a Quality Assurance Manager to join our team based in Senoko, Singapore. As Quality Assurance Manager, you will focus on the effective deployment, development,...

  • quality assurance manager

    3 days ago

    Singapore HSM SHIP MANAGEMENT PTE. LTD. Full time $13,200 - $180,000 per year

    We are seeking a highly experienced and proactive Quality Assurance Manager to lead and maintain our Quality Management Systems in compliance with ISO 9001:2015 and ISO 45001:2018 standards. This role is critical in ensuring operational excellence, continuous improvement, and compliance with all regulatory and client requirements.Key ResponsibilitiesOversee...

  • Quality Assurance Manager

    1 week ago

    Singapore FAIRY GROUP VENTURES PTE. LTD. Full time

    Develop, implement and maintain quality assurance standards and procedures for our central kitchen in line with company goals and industry best practices - Conduct regular audits and inspections of kitchen operational processes to ensure compliance with food safety, hygiene and quality standards - Investigate food quality issues and customer complaints,...

  • Quality Assurance Manager

    5 days ago

    Singapore W.H. BRENNAN & COMPANY (PRIVATE) LIMITED Full time

    **Quality Assurance Manager **Job Responsibilities: **Quality Assurance** - Establishment, Maintenance and Continuous Improvement of Company’s Quality Management System (QMS), Class Approvals (Marine) and Regulatory Requirements (Part 145). - Plan, organise and take lead to drive Quality initiatives and promote quality culture within the company. -...

  • Quality Assurance Manager

    2 weeks ago

    Singapore Merck Group Full time

    Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich...