Responsibilities

• Responsible to establish and oversee Qualityfunctions and strategies, for cell therapy programs and otherprovided services, including but not limited to area of qualityassurance, quality control, compliance and batchdispositions.

 

• Responsible in implementation and maintainQuality Management Systems, and to ensure compliance topolicies/standards of National Speciality Centres and applicableregulations.

 

• Drives performance improvement and monitoreffectiveness of QMS by identifying, defining and establishing keyquality indicators for management reviews.

 

• Supportscross-functional team in ensuring that the clinical program isconducted and reported according to applicable current GxP,regulations (e.g. FDA, HSA) and standards (e.g. FACT/JACIE). In thebeginning phase of project, supports and provides quality oversightto Technology Transfer requirement for clinical trial materialproduction.

 

• Lead and inspire a strong quality organizationby attracting and developing talents, lead implementation of talentdevelopment strategies within organization.

 

• Responsible as thecentre’s Quality representative to regulatory authorities andthird-party inspections.

 

• Alerts seniormanagement of significant quality and compliance risks.
• Any other responsibilities assigned by SeniorManagement.

 

Requirements

• Bachelor/Master’s Degree, or higher, inScience, Pharmacy, Pharmaceutical Science, or equivalent, withpreference of more than 10 years of relevant work experience inQuality Lead role in the pharmaceutical/biotechnology/medicaldevice/healthcare industry.

 

• Extensive knowledgeof quality control, quality management system and validationsrequirement, preferably with third party customer/supplier orvendor management experience.

 

• Extensive knowledgein regulations and industrial guidance, and experience withtechnological transfer.

 

To find out more about thisopportunity, please contact Lionel Liewatlionel.liew@gmprecruit.com.

 

We regret that only shortlistedcandidates will be notified.

 

GMP Technologies (S) Pte Ltd   |   EALicence: 11C3793 |   EA Personnel: Lionel Liew  |   Registration No: R1330693

 

This is in partnershipwith the Employment and Employability Institute Pte Ltd(“e2i”).

 

e2i is the empowering network for workers andemployers seeking employment and employability solutions. e2iserves as a bridge between workers and employers, connecting withworkers to offer job security through job-matching, career guidanceand skills upgrading services, and partnering employers to addresstheir manpower needs through recruitment, training, and jobredesign solutions. e2i is a tripartite initiative of the NationalTrades Union Congress set up to support nation-wide manpower andskills upgrading initiatives.

 

By applying for this role, you consent to GMPTechnologies (S) Pte Ltd’s PDPAand e2i’sPDPA.