- Quality Manager responsible for QA and QC functions for Biological Services organisation
- Bishops Stortford, Hertfordshire based
- Innovative and leading biological support for clinical trials
- Salary to £60,000 + benefits
- Interim role for 12-15 months employed by the company, on their payroll with full benefits
- Broad quality management experience from an environment dealing with human tissues
Based in Bishop’s Stortford this is an excellent opportunity to take responsibility for the QA and QC functions and teams with a relatively small, and growing provider of human tissue related bio services supporting clinical trials. The role encompasses overseeing the QMS ensuring compliances including GMP, GLP and ISO 9001. This role is offered on an interim basis to cover maternity leave for a 12 to 15 month period working directly for the company on their payroll with full benefits. The company environment is supportive and collaborative with the organization being highly client, service and quality focused.
The company is one of the most reputable, successful and growing providers of biological services to pharmaceutical and other organisations running clinical trials. Based in Bishop’s Stortford the site has around 60 staff with state-of-the-art GMP, GLP, EUTCD and ISO 9001 regulated facilities. The services they offer support client’s clinical trial operations and include patient sample kit assembly, packaging, labelling and distribution; sample collection; sample analysis and long term storage of samples. While operating as an autonomous business the company benefits from being part of a large global group that provides a wide range of scientific support products and services
The Quality Manager has overall responsibility and accountability for the quality facility that includes the small QA and QC teams, the QMS, GMP and ISO 9001 compliances and adherence to the EU Tissues and Cells Directive (EUTCD). Responsibilities will include the following:
- Oversee the Quality Management System to ensure it is supports all applicable regulations and standards.
- Fosters a site-wide quality culture as well as continuous improvement.
- Responsible for internal and external audit programs as well as regulatory inspections.,
- Responsible for the CAPA and complaint handling systems plus quality metrics related to product/process quality and customer allegiance
- Develop techniques designed to maintain awareness of SOP’s and GMP
- Develop and direct quality improvements
- Implement and monitor key performance indicators (KPI’s)
- Designated Individual for HTA License, Person Responsible for HFEA License, Responsible Person for the MHRA and responsible for IMP and Specials licenses
- Support GLP compliance for the laboratory facilities
- Responsible for all required Quality Technical Agreements between the company and clients
- Overall responsibility for the Quality Assurance and Quality Control d teams including Validation and QP functions
You will join and head a supportive Quality team within a company that has a reputation for its development and support programmes and positive working environment as well as quality standards.
In addition to a competitive salary to £60,000 a comprehensive benefits package is on offer including private health care, bonus and pension scheme.
The successful candidate will have previous experience in the management of quality operations within a Biopharma, Bio Services or Biological Sciences related environment working with human tissues. This will encompass extensive experience working in a MHRA regulated environment with strong experience of GMP and ISO 9001 standards plus experience of HTA/HFEA and EUTCD regulations. You will be capable of leading and directing two small teams with a highly organised and customer service oriented approach.
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This is an interim role