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Associate Director Clinical Quality Assurance

3 months ago

Oxford, Oxfordshire, United Kingdom Northreach Full time
Job Description

Northreach is a recruitment agency that connects businesses with top talent in the cell & gene therapy, fintech, and digital sectors. Our mission is to provide clients and candidates with a seamless and personalised recruitment experience and create a positive work environment that encourages equality, innovation, and professional growth.

We are long standing partners with a very exciting and growing Biotechnology company based in Oxford and am assisting them in a search for an Associate DIrector of Clinical Quality Assurance (GCP). The successful candidate will be reporting directly to the Head of QA and spearhead all activities related to GCP.

Main Duties and Responsibilities include:

  • Ensuring changes in GCP practices are communicated, adopted and implemented throughout the organisation by maintaining current knowledge of local and international regulations
  • To create/author/approve or input into SOPs and policies for those relating to GCP activities
  • To provide GCP training for staff including the preparation of material and delivery of training. To include onboarding/induction training and refresher training
  • To take a lead role on behalf of QA on all GCP investigations including serious breaches and Urgent Safety Measures and to communicate these effectively within the organisation and escalation to the senior leadership team
  • To represent Quality on the clinical projects undertaken and be the main QA contact for CROs and GCP Laboratories
  • Perform internal audits. These to include document audits such as Protocols, Investigator Brochure, Clinical Study Reports and regular audits on Trial Master File and Sponsor Oversight Files.
  • Support the maintenance of the Approved Supplier list and to be the lead QA on the management and scheduling of all GCP supplier and site audits. Ensure a current schedule is maintained for these activities.
  • Provide input into the QMS and at the regular Quality Management Review Meetings on GCP activities and metrics. To chair these in the absence of the Head of Quality.
  • Represent QA on any risk assessment activities relating to GCP/clinical trials
  • Complete all GXP training relevant for the role
  • Working with the Head of Quality to ensure we are 'Inspection Ready', this includes the building of the GCP Inspection Dossier
  • Reviewing Computer Systems Validation documents and providing support
  • Ensuring there are adequate data integrity practices in place and compliance to ALCOA+
  • Input into RFP and bid defence meetings where required
  • Providing advice and support to the clinical teams and business as required
  • Deputising for the Head of Quality in their absence

Knowledge and Experience required:

  • Excellent knowledge of GCP, in particular ICH E6 and knowledge of MHRA and EMA. Knowledge of TGA and FDA regulations desirable
  • Minimum of 7 years' experience working as a GCP Quality professional in a management/ leadership role within a Pharmaceutical/Biotechnology industry
  • Experience at conducting service provider, site and internal audits highly desirable
  • Experience of building and maintenance of Sponsor Oversight File (SOF)
  • Experience in hosting GCP Inspections
  • Experience in IT Systems validation desirable
  • Experience in implementation of general data protection regulations desirable
  • Operational knowledge of GMP, knowledge of GLP and GCLP desirable

Northreach is an equal-opportunity employer and we do not discriminate against any employee or applicant for employment based on race, colour, religion, sex, national origin, disability, or age. We are committed to promoting diversity, equity, and inclusion in the workplace and hiring practices, therefore only partner with business that promote DEI. We strive to create a welcoming and inclusive environment for all employees.