Salary: Negotiate

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Summary:

A Quality Management Manager is required to lead and drive compliance to all quality processes and procedures developed for in-vitro and in-vivo preclinical services and products, clinical services and consumables business units. This position will report to General Manager, Singapore.

Essential Functions:

1. Be responsible for the establishment and maintenance of a quality management system for in-vitro and in-vivo preclinical services and products, and Onco-PDO clinical services business unit.

2. Set requirements for all products and service assays based on prevailing industry standards and regulations, and monitor for compliance.

3. Initiate the development of specific quality procedures and SOP’s by engaging Process Owners and internal Approvers. Maintain full sets of quality procedures and SOP’s and implement regular updates to these documents.

4. Develop internal quality management tools to regularly assess all product and assay development procedures to identify deviations from quality standards and implement corrective action plans.

5. Plan and conduct internal audits of all business units, provide recommendations and training for process improvement.

6. Investigate causes of quality problems, propose solutions and engage all key stakeholders in implementation.

7. Take appropriate actions in championing and developing the culture of quality improvement and awareness.

8. Initiate and implement improvements to production processes that lead to overall increases in product and service quality, and process efficiency.

9. Work together with Department Heads and Project Leaders to discuss solutions to quality issues.

10. Create production plans for new products to guarantee quality from stage one.

11. Solicit feedback from customers to assess whether their requirements are being met.

12. Plan, develop and support the training of employees in Quality Management and Quality Control processes and procedures.

13. Provide continuous education on newly-developed Quality Control techniques.

14. Act as liaison person for any external audits or inspections by regulatory authorities or Clients. Lead the audit process from preparation, attendance, follow up to close-out.

15. Provide regular report of Quality Management activities and performance.

Other Responsibilities:
May represent company at professional meetings, seminars or conferences. Performs otherwork-related duties as assigned.

Requirements:

1. Bachelor’s or Master’s degree in Life Science/Pharmacy, or equivalent combination of education and experience.

2. At least 3 year’s experience in a quality management, QA/QC role within pharma or life sciences related industry.

3. Experience in devising and establishing a company’s quality procedures, standards and specifications.

4. Good knowledge of quality management standards and production management (e.g. ISO 15189 / 13485, GCP, GMP, GLP).

5. Hands on experience liaising with the HSA/MOH/US FDA etc and various other regulators preferred.

6. Working knowledge in Singapore regulations (e.g. Human Biomedical Research Act, Healthcare Services Act, Medical Device registration etc) and/or other regional regulations for in-vitro diagnostics or medical devices will be an advantage.

7. Strong in communication, presentation, documentation, interpersonal skills and a team-player.

8. Proficient computer skills in Word, Excel, PowerPoint, and Internet.

9. Basic computer skills using MS Project.

10. Ability and flexibility to work under pressure, handle multiple tasks to meet deadlines and deliver high quality work in a dynamic environment.

11. Methodological, resourceful and possess problem-solving skills.

12. Highly driven and self-motivated, with ability to work independently with minimal supervision.

********* attention to detail and ability to multi-task and deliver on projects, priorities, schedules, and deliverables.

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