Responsibilities
• Responsible to establish and oversee Quality functions and strategies, for SCTH 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’s 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.
• 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.
To find out more about this opportunity, please contact Lionel Liew at [email protected].
We regret that only shortlisted candidates will be notified.
GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Lionel Liew | Registration No: R1330693
This is in partnership with the Employment and Employability Institute Pte Ltd (“e2i”).
e2i is the empowering network for workers and employers seeking employment and employability solutions. e2i serves as a bridge between workers and employers, connecting with workers to offer job security through job-matching, career guidance and skills upgrading services, and partnering employers to address their manpower needs through recruitment, training, and job redesign solutions. e2i is a tripartite initiative of the National Trades Union Congress set up to support nation-wide manpower and skills upgrading initiatives.
By applying for this role, you consent to GMP Technologies (S) Pte Ltd’s PDPAand e2i’s PDPA.
