QA Manager

Job Ref: J25454
Sector: Science
Sub-sectors: Biotech/Life Sciences, Pharmaceuticals, Medical Devices
Date Added: 14 February 2018
  • Cambridge, Cambridgeshire, England, UK
  • £38,000 - £46,000 per Annum
  • Bec Johnston2
  • 01223 235203

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Quality Assurance Manager - Biotechnology

Our Global client based in Cambridge, is an award-winning and eminent leader in the field of gene-editing and clinical application to the R&D and cell-modification market.

They are hiring for a QA Manager to consolidate a team of skilled and experienced QA professionals, and develop a global strategy to enhance staff engagement, promote best practice and reduce non-conformance and corrective actions.

Key role requirements include but are not limited to:

  • Working closely alongside the Head of Quality to oversee and ensure the continuous follow-up of global and site level QMS activity.
  • Management of site quality management systems, procedures and audit trails to guarantee site safety and product quality.
  • Taking accountability of strong cross-division engagement to promote and improve quality and safety on site.
  • Working within the parameters and expectations of GCP and medical device regulations (ISO 13485). You will be expected to deliver training and guidance on these areas to other colleagues.
  • Provision of monthly reports to management including regulatory metrics and raising any CAPA issues. Supporting continuous improvement strategies.

Person Specification:

  • Extensive background within the Quality field, ideally from Pharmaceutical or medical device sector.
  • BSc or equivalent in a technical field
  • Strong influencing and negotiation skills. Natural leader, able to engage and direct others.
  • Accustomed to working to GMP/GCP/FDA/ ISO 9001 and 13485 standards and able to demonstrate applications within the business.
  • Expert level in non-conformance and corrective-action, backed-up by risk analysis and complaint handling.
  • Able to demonstrate use of Six Sigma and Lead methodologies in relation to continuous improvement.

Company benefits:

  • 25 days holiday and one paid day each year for volunteering
  • Medical, life and health insurances
  • Childcare vouchers
  • Group Pension, enhanced company contribution
  • Employee share purchase plan

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.