head of quality and compliance, apac commercial in Singapore

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job details

posted
location
singapore
specialism
life science
job type
permanent
working hours
Full-Time
experience
10 years
reference number
91M0127036_1540368959
contact
rachel ren, randstad
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job description

about the company
A world leading manufacturer of Point-of-Care diagnostics kits and devices. With extensive global presence and strong brand recognition, this company has exceptional growing strategies. It has a dynamic and innovative culture, and offers immense career opportunities for its employees. If you are ambitious and embrace challenges, this will be the best platform to unleash your potential.

about the job

You will report to your Global VP of Quality and Regulatory Affairs, and be responsible for oversight, implementation, maintenance and improvement of Quality and Compliance functions within APAC Commercial affiliates and distributors. You will directly manage a Commercial affiliate quality team with members based across multiple territories in the region, and act as a strategic partner to APAC commercial leadership. You will:

  • Establish, maintain, and improve quality and compliance in the APAC commercial structure
  • Communicate the importance of an effective and compliant Quality System to internal employees and partners, assess and report on Quality System effectiveness to management, and promote a Quality First culture
  • Lead and manage quality and compliance matters associated with APAC affiliates and their distributors
  • Oversee APAC affiliates in the development and implementation of quality improvement plans, as necessary, that take a risk-based approach in addressing identified deficiencies, corrections and improvements
  • Management and develop APAC Commercial’s key quality personnel, including organisational structure, workload analysis, recruitment, competency assessment, appointment and dismissal, and management of regional quality budget
  • Participate in activities with national competent authorities and APAC regional quality organisations and NGAs with a view to enhancing the company brand as an ethical, responsible and compliant corporation


skills and experience required

  • Degree in science or health-related discipline
  • 10 years’ of quality / compliance / regulatory management experience in a medical device, in-vitro diagnostics, or pharmaceuticals company
  • Through knowledge of quality systems / audits in APAC territories
  • Demonstrated ability to influence change upwardly and laterally across the business
  • Proven people management experience



To apply online please use the 'apply' function, alternatively you may contact Rachel at +65 6510 1338.
(EA: 94C3609/ R1767439 )







skills

Quality, Regulatory, Compliance, IVD, Clinical Diagnostics, APAC, regional, FDA, ISO

qualification

no additional qualifications required

educational requirements

Bachelor Degree