Manager, Quality Operations, ACTRIS 1

Consortium for Clinical Research and Innovation Singapore; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

An innovative organization seeks a dedicated Quality Manager to oversee Good Manufacturing Practices and ensure compliance with industry standards. This role involves providing quality oversight, conducting risk assessments, and leading audits to maintain high-quality operations. The successful candidate will join a forward-thinking team focused on advancing clinical research and innovation for healthcare in Singapore. With a commitment to excellence and a passion for improving patient outcomes, this opportunity offers a chance to make a significant impact in the field of cellular therapeutics and regenerative medicine. If you are eager to contribute to groundbreaking work in clinical trials, we want to hear from you!

Qualifications

• 5-10 years in Pharmaceutical Quality Systems in GMP/GDP/ATMP industry.
• Knowledge of GMP/GDP/HSA/HPRA regulatory requirements.

Responsibilities

• Provide quality oversight for GMP/GDP activities.
• Lead internal audits and external inspections preparation.
• Identify compliance risks and communicate to Head, Quality.

Skills

Quality Management Concepts

Regulatory Compliance

Risk Assessment

Auditing

Education

Degree in Science

Degree in Engineering

Degree in Life Sciences

Certified Quality Manager

Job description

The Consortium for Clinical Research and Innovation, Singapore (CRIS) brings together six national R&D, clinical translation and service programmes to advance clinical research and innovation for Singapore, and establish important capabilities for a future-ready healthcare system.

Business Entities under CRIS include:

• Singapore Clinical Research Institute (SCRI)
• Advanced Cell Therapy and Research Institute, Singapore (ACTRIS)
• Cardiovascular Disease National Collaborative Enterprise (CADENCE)

Together, CRIS makes a positive difference to Singapore patients and researchers by ensuring that these clinical research platforms and programmes are at the cutting edge of capability development and innovation. If you are as passionate as we are in clinical trials and research, we want you!

ACTRIS

The Advanced Cell Therapy and Research Institute, Singapore (ACTRIS) was established to meet the increasing clinical demand of using cellular therapeutics to treat various life-threatening diseases. ACTRIS’ vision is to be the national and regional Centre of Excellence for discovery, process development and manufacturing of cellular-based therapeutics across the broad spectrum of immunotherapy and regenerative medicine, encompassing both investigational and approval products for the local market. We also provide value-added services such as workforce training, regulatory facilitation and ancillary material standardization, pertaining to delivery of cellular therapy to patients.

What you will be working on:

• Provide Quality Oversight for Good Manufacturing Practices / Good Document and Data Practices activities.
• Process Owner and Administrator for Quality Operations related policies and SOPs.
• Provide quality oversight for Gap and/or quality risk assessments between assigned quality management process and applicable CTGTP / GMP / GDP regulations, guidance and industry standards.
• Review and provide inputs to batch records, batch disposition, batch release, training requirements, change controls, deviations, CAPA and investigations.
• Lead and/or support internal audits and external inspections preparation.
• Lead and/or participate in Quality Management Review.
• Identify and communicate compliance risks to Head, Quality.
• Other responsibilities as assigned by Head, Quality.

What we are looking for:

EDUCATION, TRAINING:

• Degree in Science, Engineering and Life Sciences.
• Certified Quality Manager (Preferred).

EXPERIENCE:

• A minimum of 5 to 10 years of relevant working experience in Pharmaceutical Quality Systems in GMP / GDP / ATMP relevant industry.
• Relevant knowledge in GMP / GDP / HSA / HPRA regulatory requirements.
• Proficient in Quality Management Concepts.

What you need to know:

Successful candidate will be offered a 3-year contract, renewable. We regret that only shortlisted candidates will be contacted. For more information about CRIS and the Business Entities, visit our websites below: