Job Description: Head of Quality
A newly established Laboratory is seeking a Head of Quality to lead its Quality department. The role involves overseeing all aspects of Quality Assurance functions, including Quality Operations, Quality Management Systems, External Vendor Quality Oversight, Quality Supplier Management, Quality Compliance and Disposition, and Quality Control.
Key Responsibilities:
- Establish and oversee Quality functions and strategies for cell therapy programs and other services, including quality assurance, quality control, compliance, and batch dispositions.
- Implement and maintain Quality Management Systems to ensure compliance with applicable policies, standards, and regulations.
- Drive performance improvement and monitor the effectiveness of QMS by identifying and establishing key quality indicators for management reviews.
- Support cross-functional teams in ensuring clinical programs are conducted and reported according to current GxP, regulations
- Provide quality oversight for Technology Transfer requirements for clinical trial material production during the initial project phase.
- Lead and inspire a strong quality organization by attracting and developing talent and implementing talent development strategies within the organization.
- Serve as the Quality representative to regulatory authorities and third-party inspections.
- Alert senior management to significant quality and compliance risks.
- Perform other responsibilities as assigned by Senior Management.
Key Requirements:
- Bachelor's or Master's Degree, or higher, in Science, Pharmacy, Pharmaceutical Science, or equivalent. Over 10 years of relevant work experience in a Quality Lead role in the pharmaceutical, biotechnology, medical device, or healthcare industry is preferred, with increasing people management responsibilities.
- Extensive knowledge of quality control, quality management systems, and validation requirements, preferably with third-party customer/supplier or vendor management experience.
- In-depth knowledge of regulations and industry guidance, with experience in technological transfer.
- Excellent communication and leadership skills, with a task-oriented approach.
- Strong critical thinking and problem-solving skills.
To find out more about this opportunity, please contact Steffan Lian at[Confidential Information]
We regret that only shortlisted candidates will be notified.
GMP Recruitment Services (S) Pte Ltd | EA Licence : 11C3793 | Lian Cher Chieh | Registration No: R 1217705
