Chief Quality Officer and Head of Biosafety (From $8k onwards)


RMA Group
8 Kaki Bukit Avenue 1 #05-05/06/07/08
01  417941
Singapore

Industry
Biotechnology
Job Specialization
Healthcare
Manages Others
Yes
Experience Required
Yes
Degree Required
Yes
Security Clearance Required
No
Pay
From $8,000.00 To $10,000.00
Per Month    
Employment Type
Employee
Work Schedule
Contractor
Travel
No Travel

Job Description
Our Client
It is Singapore's lead public sector R&D agency. Through open innovation, it collaborates with partners in both the public and private sectors to benefit the economy and society. As a Science and Technology Organisation it bridges the gap between academia and industry.
 
Job Description (Quality)
 SDL is clinical testing laboratory licenced under the Private Hospital Medical Clinics Act (PHMC). A high performing Quality Management System underpins all the activities of a clinical testing lab and the QA group supports, monitors and advises all functions within SDL.
 The role of Chief Quality Officer is to lead the QA team in the implementation of the Quality Management System, Standard Operating Procedures, and Work Instructions including change control.
 Oversee the staff training for Quality aspects.
 Develop, oversee and present the QC performance matrices of SDL including equipment maintenance and performance and sample handling.
 Advisor to senior management on all Quality matters pertaining to SDL.
 Manage the EQA process.
 Manage the Internal and external audit programmes and also any inspections.
 Be part of the senior decision making team at SDL ensuring that SDL is always compliant with all aspects of its PHMC licence conditions.
 Oversee the handling of all positive samples within SDL especially dispatching to NPHL.
 The QA team provide support and sign off of all investigations into performance issues within SDL.
 Develop and operate the Nonconformance reporting process, identify and inform senior management of recurring issues so that effective corrective actions can be taken.
 Oversee an effective Management of Change Process ensuring that all SDL processes are appropriate for the task and also that all staff are fully trained on the latest versions of all SOP and WI.
 
Job Description (Biosafety)
 Manage the biosafety team on a day to day basis.
 Approve all risk assessments related to Biosafety.
 Oversee the monthly safety inspections and ensure that all action items are completed.
 Present Biosafety matters to senior management and advise them on actions.
 Ensure that SDL is in compliance with all applicable WHS regulations.
 Oversee the PPE awareness and testing programme within SDL.
 Represent SDL on A*Star safety meetings.
 Assist in oversight of COVID isolation protocols as applied to SDL.

 
Working Schedule:
Working pattern of 5 days’ work week.
Working location at Biopolis

If interested, please send your updated CV in word format at [email protected] stating your current/ expected salary and availability to take it forward. All resumes will be treated with the strictest confidentiality. We regret to inform that only shortlisted candidates will be notified.

To expedite processing, you can lodge your application directly at https://www.rmaconsultants.com.sg/employment/registerjobseeker.aspx or https://bit.ly/expeditejobappl


Michelle Wong (EA Regn. No. R1872874)
RMA Consultants Pte Ltd (EA Licence No. 93C4403)
Job Requirements
 Ph.D. in a biological science subject or minimally a B.Sc in chemistry, biochemistry or a related subject
 Minimum 5 years’ experience in Quality Assurance in a managerial role within a clinical diagnostic laboratory or minimum 5 years’ experience in Quality Assurance in a managerial role within an in intro diagnostic company.
 Experience in being part of a senior management team, managing a team with diverse experience and ability, and being confident to present and support sometimes unpopular positions at senior management level.
 Have worked in both the commercial and government sectors.
 Have been responsible for setting up and implementing Biosafety/Safety protocols within a research laboratory.

Technical Skills (Quality)
 A thorough working and theoretical knowledge of the principles and implementation of Quality Management in In vitro diagnostic development and in clinical laboratories.
 A thorough knowledge of the regulatory environment for IVD and clinical laboratories especially in Singapore but also regionally and globally.
 Strong knowledge of ISO15189
 CAP processes and principles for clinical diagnostic labs
 Strong Knowledge of ISO13485 and process for the development of IVD and LDT
 Understanding of Singapore regulations under PHMC and HCS Act.
 Trained as an Internal Auditor for clinical diagnostic labs
 Recent experience of working within a clinical diagnostic laboratory

Technical Skills (Biosafety)
 Thorough knowledge of biosafety and WHS regulations in Singapore.
 Ability to manage biosafety team and to oversee the training of all SDL staff in biosafety compliance.

Interpersonal Skills
 Proven skills in managing a diverse team working in different shifts.
 Willingness to take all roles within the team when required to cover for absent team members
 Good pedagogical aptitude to educate and improve the skill sets of the inexperienced QA team.
 Personable character and able to interact with staff at all levels.
 Dedicated and hard working to act as a model to members of their team.
Employer
RMA Group
RMA Group
8 Kaki Bukit Avenue 1 #05-05/06/07/08
417941
Singapore