Quality Manager - Biotech
*The company is happy to consider flexible working options*
This is a great opportunity to join a biotech company in Cambridge who are working on cancer diagnostics to help improve and extend cancer patients lives by enabling better targeting of therapies and early detection of treatment.
They are seeking an experienced Quality Manager to build and main a Quality Management System (QMS) to meet ISO 13485 requirements. This role will report into the COO and be responsible for the QMS and Quality Assurance function across the company’s UK and US sites.
Some of the key responsibilities will include:
- Delivering and maintaining a quality management systems for ISO 13485 including all sub processes
• Promote applicable regulatory, QMS and customer requirements throughout the organisation
• Developing and delivering training
• Planning, initiating and managing quality improvement projects
• Supporting product and software development teams with design control and risk management
• Supporting compliant handling investigations
• Be point of contact for certification authorities, arranging and planning for assessments
• Assist drafting and compiling product documentation for regulatory submissions
The company is looking for someone with the following skills/qualifications:
Previous implementation and maintenance of an ISO 13485 QMS
• Demonstrated experience with IVDs and LDTs
• Working knowledge of other standards including; 21 CFR 820, 21 CFR Part 11, IEC 62304, ISO 14971, and GAMP5
• Great leadership skills
• Degree in science/medical or technical field
• Proven industry experience in a regulated environment
In return for a motivated quality manager setting up their QMS system this company are offering a great range of benefits including very flexible working options, competitive salary and pension, with a generous annual leave allowance.[EM1]
If you would like to apply or hear more about this opportunity please do not hesitate to contact me either via email email@example.com or phone 01216163466.
Furthermore, if you are interested in hearing about other roles within the Bioinformatics and Genomics industry[EM2] , please feel free to contact me for a confidential discussion.
Keywords: Quality Manager / QMS / Biotech / Biotechnology / ISO 13485 / Cancer / Oncology / Regulatory Affairs / Reg Affairs / Quality Management System / IVD / LDT / In Vitro Diagnostics / QA / Quality Assurance / Cambridge / Director / Manager