Overview
Service Quality Partner x 2 - genomic data analysis focus. Location flexibility with office locations in Cambridge, Leeds & London.
Responsibilities
* Provide Quality Management leadership within an allocated genomic service to promote a continuous quality improvement programme and culture. Set clear quality goals, roadmaps/programmes of work and vision, with objective evidence and technical understanding for the changes required.
* Extract, analyse and interpret data from multiple sources to assess quality performance across the Quality System and service processes; set and revise key performance indicators and drive demonstrable improvement in a systematic manner with the service leadership.
* Ensure compliance with all Quality regulatory requirements within the genomic service, providing interpretation of developing and current regulations, based on genomic data analysis and understanding of software design and control (in conjunction with the Quality Assurance team).
* Provide independent investigation and/or review of incidents, changes and validation/verification activities; analyse trends and ensure prioritised action, including formal reporting where required (post-market surveillance).
* Collaborate with other assurance functions to develop an internal and external supplier audit programme that assures compliance and drives continuous improvement through streamlined processes.
* Maintain the technical file, Schedule of Accreditation and associated registration records relevant to the Service, including rationales for changes at the boundaries of intended use, through deployment of AI/ML or changes impacting accreditation/registration.
* Be the point of contact for regulatory parties (e.g. UKAS, MHRA and BSI) leading the Service through inspections, reportable incidents and consultations, ensuring clear communication, risk assessment, business ownership, and coordinated responses.
* Maintain a documented Quality System compliant with ISO 13485, ISO 15189 and applicable guidelines; author, review and approve associated quality processes with clear controls and monitoring.
* Remain current with genomic data science developments to ensure the Service remains state of the art and reflects user needs from incidents and feedback.
* Demonstrate alignment with Genomics England virtues and leadership behaviours in all aspects of the role.
Qualifications
Strong understanding of Quality regulation and standards around in vitro diagnostics with good understanding of genomic data analysis. A genetics or molecular biology, biomedical science degree or relevant experience, plus some experience in software engineering/development of digital services.
Additional Information
Closing date for applications: Thursday 25th September at 11.59pm
Salary from: £51,000
Benefits
* Generous Leave: 30 days’ holiday plus bank holidays, additional leave for long service, and option to apply for up to 30 days of remote working abroad (approval required).
* Family-Friendly: Flexible working, enhanced maternity/paternity/shared parental leave benefits.
* Pension & Financial: Defined contribution pension (Genomics England double-matches up to 10%), Life Assurance (3x salary).
* Learning & Development: Individual learning budgets, support for training and certifications, reimbursement for one annual professional subscription (approval required).
* Recognition & Rewards: Employee recognition programme and referral scheme.
* Health & Wellbeing: Subsidised gym membership, Headspace access, Employee Assistance Programme, eye tests, flu jabs.
Equality and Inclusion
Genomics England is committed to an inclusive environment promoting equity, diversity and inclusion. We welcome applicants from diverse backgrounds and do not discriminate on disability, ethnicity, gender, gender identity, religion, sexual orientation, or social background. We follow non-discrimination and equity policies and outline adjustments available in the recruitment process.
Working Model
Genomics England operates a blended working model with some in-office presence. Most roles involve coming into the office a minimum of 2 times per month, with flexibility depending on role. Office locations: Canary Wharf, Cambridge and Leeds.
Background Checks
All successful candidates are subject to a Standard Disclosure and Barring Service (DBS) check. Applicants should disclose any previous offences at the point of application as unspent convictions may affect eligibility due to healthcare work requirements.
#J-18808-Ljbffr