Cell and Gene Therapy Quality Specialist

1 week ago

Singapore beBeeQuality Full time

The role involves ensuring compliance with regulatory requirements and standards, including cGMP and GDP. A strong understanding of quality systems and processes is necessary, as well as experience in deviation management, CAPA, and change control.

Key Responsibilities
  • Initiate, investigate, and close deviations, and manage CAPA processes.
  • Review, assess, and manage change controls related to materials, equipment, processes, and documentation.
  • Perform thorough review of executed batch manufacturing records, critical logbooks, and associated documentation.
  • Provide real-time QA support on the manufacturing floor during production, aseptic operations, and changeovers.
  • Review, revise, and approve GMP documentation, including Standard Operating Procedures (SOPs), Master Batch Records (MBRs), and work instructions.
  • Conduct gap assessments of processes and procedures against current GMP and regulatory expectations.
  • Support internal and external audits, including preparation, hosting, documentation retrieval, and response drafting.
  • Participate in continuous improvement initiatives and cross-functional project teams to enhance quality systems and operational efficiency.
  • Collaborate with manufacturing, QC, validation, and engineering teams to ensure timely execution of quality deliverables.
  • Support inspection readiness activities and promote a strong culture of compliance and quality awareness.
  • Train and mentor operations staff on quality procedures and best practices as needed.
  • Utilize electronic Quality Management Systems (eQMS) to manage quality workflows and records.
  • Support Quality Control function as needed, including review of QC documentation, data trending, and investigations.
Requirements
  • Bachelor's or Master's in Life Sciences, Biotechnology, Pharmacy, or equivalent.
  • 3–5 years of GMP QA/Quality experience, preferably in Cell & Gene Therapy, Biologics, or ATMP manufacturing.
  • Strong knowledge of cGMP, GDP, FDA/EMA standards, PIC/S, ICH Q7/Q9, Annex 1, data integrity principles.
  • Proficiency with quality systems (deviation, CAPA, change control, document control, batch release).
  • Familiarity with eQMS, and electronic document systems.
  • Excellent communication, analytical, problem-solving, and collaborative skills.
  • Able to work independently and under tight timelines; experience in Q&A shop-floor oversight.
  • Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).

  • Cell Manufacturing Specialist

    2 weeks ago

    Singapore SCG CELL THERAPY PTE. LTD. Full time

    SCG is a leading biotechnology company focusing on the development of novel immunotherapies in infections and its associated cancers. The company targets the most common cancer-causing infections: helicobacter pylori, human papillomavirus, and hepatitis B, and develops a broad and unique pipeline of T cell therapies, antibodies, and therapeutic vaccines...

  • Cell and Gene Therapy Quality Specialist

    23 hours ago

    Singapore beBeequality Full time $90,000 - $120,000

    Job Description">This role involves supporting Quality functions from Good Manufacturing Practice (GMP) readiness to ongoing compliance for cell and gene therapy manufacturing in a cGMP environment. Ensuring adherence to global regulatory standards through oversight of operations, documentation, and quality systems is crucial.">Main...

  • Ap Cell

    28 minutes ago

    Singapore Johnson & Johnson Full time

    Johnson & Johnson is currently seeking a Asia Pacific Cell & Gene Therapies CoE lead - Associate Director to join our Asia Pacific Commercial team. **KEY RESPONSIBILITIES** Primary responsibilities for this leadership position will include but not limited to: - Setting the overall regional Cell and Gene CoE strategy, developing business plan and programs...

  • Cell and Gene Therapy Product Lead

    16 hours ago

    Singapore beBeeManufacturing Full time $100,000 - $150,000

    Lead Manufacturing TeamAt our organization, we specialize in translating innovative ideas into commercially viable products at affordable prices. We utilize cutting-edge biology to develop novel products, often utilizing cells as a factory to derive our target product.Effective leadership and strong communication skills are essential for success in this...

  • Highly Motivated Cell Therapy Quality Professional Wanted

    5 days ago

    Singapore beBeeQuality Full time

    Cell Therapy Quality SpecialistJob Description:As a Cell Therapy Quality Specialist, you will play a vital role in ensuring the quality and compliance of cell therapy manufacturing processes. This involves collaborating with cross-functional teams to identify and implement quality improvements, developing and maintaining quality systems and documentation,...

  • Quality Assurance Specialist

    3 days ago

    Singapore beBeeQualityAssurance Full time

    Job DescriptionWe are seeking a Quality Assurance Specialist to execute the assigned quality process for our stem cell therapy programs and other provided services. The ideal candidate will have good knowledge in quality management system concepts, regulations, and industrial guidance, especially for stem cell / cell and gene therapy.

  • Cell Therapies Specialist

    4 days ago

    Singapore beBeeTherapy Full time

    Job DescriptionWe are seeking a Cell Therapies Specialist to join our team. As a seasoned professional, you will be responsible for driving the production of cell & gene treatments and working collaboratively with our globally recognized network.You will have the opportunity to gain unparalleled exposure to innovative biotechnology and innovation while...

  • Research Associate

    1 week ago

    Singapore WUXI ADVANCED THERAPIES SINGAPORE PTE. LTD. Full time

    **Research Associate **- Cell Therapy **Location**: A*Star, BTI **Company Overview**: WuXi Advanced Therapies - Accelerating Progress and Time to Market - Integrated Manufacturing and Testing Service Platform - Solutions From Gene of Interest to Global Commercial Launch The advanced therapies business unit of WuXi AppTec is a leading cell and gene therapy...

  • Quality Control Engineer

    2 weeks ago

    Singapore SCG CELL THERAPY PTE. LTD. Full time

    **Quality Control Engineer SCG is a leading biotechnology company focusing on the development of novel immunotherapies in infections and its associated cancers. The company targets the most common cancer-causing infections: helicobacter pylori, human papillomavirus, and hepatitis B, and develops a broad and unique pipeline of T cell therapies, antibodies,...

  • Intern - Biotechnologist (Gene)

    41 minutes ago

    Singapore GenScriptProBio Full time

    **About GenScript**: GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as...