- Responsible to establish and oversee Quality functions and strategies, for cell therapy programs and other provided services, including but not limited to area of quality assurance, quality control, compliance and batch dispositions.
- Responsible in implementation and maintain Quality Management Systems, and to ensure compliance to policies/standards of National Speciality Centres and applicable regulations.
- Drives performance improvement and monitor effectiveness of QMS by identifying, defining and establishing key quality indicators for management reviews.
- Supports cross-functional team in ensuring that the clinical program is conducted and reported according to applicable current GxP, regulations (e.g. FDA, HSA) and standards (e.g. FACT/JACIE). In the beginning phase of project, supports and provides quality oversight to Technology Transfer requirement for clinical trial material production.
- Lead and inspire a strong quality organization by attracting and developing talents, lead implementation of talent development strategies within organization.
- Responsible as the centre’s Quality representative to regulatory authorities and third-party inspections.
- Alerts senior management of significant quality and compliance risks.
- Any other responsibilities assigned by Senior Management.
Requirements
- Bachelor/Master Degree, or higher, in Science, Pharmacy, Pharmaceutical Science, or equivalent, with preference of more than 10 years of relevant work experience in Quality Lead role in the pharmaceutical/biotechnology/medical device/healthcare industry, preferable with increasing people management responsibilities.
- Extensive knowledge of quality control, quality management system and validations requirement, preferably with third party customer/supplier or vendor management experience.
- Extensive knowledge in regulations and industrial guidance, and experience with technological transfer.
- Excellent communication and leadership skills and is task oriented.
- Critical thinking and problem-solving skill are of advantage.
Interested and qualified candidates, please send in your resume to [email protected]
Ivy Yong Shi Mei
R2198995
Recruit Express Pte Ltd 99C4599
