Quality and Compliance Manager (Taipei)
UK company with the latest analysis procedure to conduct various genetic test
Provides high-quality sequencing and customized bioinformatics solutions
Our client's company is founded 10 years ago and has been acquired by a well-known UK company, they provides high-quality sequencing and customized bioinformatics solutions, Cloud-based NGS Platform and genetic testing services for research institutions, universities and hospitals as well as domestic and foreign industries. They own two major NGS platforms (Illumina and Life Technology) and in 2013, they also passed the certification of Illumina HiSeq2500 TAF (No. 2738).
- Application of an electronic Quality Management Systems and ensure the implementation of the Quality Policy to site.
- Ensure compliance for both the testing laboratory and the Technical Support / Reagent sales management.
- Support the Team cross functionally for all Quality/Compliance related activities.
- Relate and function effectively with applicable accrediting and regulatory agencies, appropriate administrative officials, the healthcare community, key company partners and the patient population served, and providers of formal agreements, when required.
- Enforce ISO 17025 and subsequent ISO 15189 certification and liaison with the accreditation services / TFDA within Taiwan. to support lab services compliance requirements.
- Full support for P2 lab set up.
- Develop procedures to ensure safety, security, quality and accuracy of results (e.g. GDPR).
- Application of knowledge/awareness of the new IVDR applicable to Taiwan.
- Support for electronic QM systems for document management and change control.
- Support for Project management linked to Taipei office.
- Management of non conformity, CAPA and Complaints.
- Development and Training support of staff to the required standards to support business compliance.
- Review and approve the design and test procedures linked to the Site Validation re-location project.
- Provide Quality input/support for analytical requests for tests and monitor all work performed to determine that clinically relevant information is being generated and approved appropriately.
- Define, implement and monitor standards of performance and quality improvement of the laboratory with metrics for monthly reporting to management.
- Ensure the provision of clinical advice with respect to products used for testing services.
- Assist in budgeting and financial management, as applicable.
- Ensure Audit coverage for the chosen laboratory suppliers management.
The role is to manage the Quality and compliance laboratory requirements to deliver a high quality clinical service to customers to the required ISO 17025 / ISO 15189 laboratory standards and QMS requirements, covering compliance for both the laboratory and Technical Services/Reagent Sales activities. Support the Head of Operations for all on site activities coverage.
- Minimum of 4 years experience in the management of a service laboratory within an IVDD or MDD environment.
- Minimum of Degree or equivalent in a suitable healthcare discipline or life science such as molecular biology, biochemistry or genetics.
- Trained to ISO standards e.g. ISO 13485, ISO 17025, ISO 15189.
- Bi-lingual or multi-lingual with fluent English, Chinese/Mandarin as a minimum
- Management experience / knowledge of medical diagnostics IVDD and IVDR , or MDD and MDR.
- GMP, GDP and GxP compliance knowledge.
- Enthusiasm and drive for continuous improvement.
- Deep understanding of diagnostic regulatory environment, clinical laboratory practices and test implementation.
- Proven track record of strategic thinking, judgment and influencing skills.
- Strong leadership attributes to set direction, generate commitment, balance long term needs and constructively resolve issues.
- Proven demonstration of effective cross-functional project team leadership.
- Ability to lead and influence through change.
- Strong teamwork and collaboration skills.
Leading company in providing high-quality sequencing and customized bioinformatics solutions, strong and experienced team in Taiwan. Great company culture and direct reporting to QA Director in UK.