+44 345 565 1725 
+44 345 565 1725 
+443455651725
Quality Systems Officer
Description
BioGrad Limited is seeking an individual with a strong passion for quality, attention to detail, and organisational excellence. The post holder will join the wider BioGrad team, supporting both Research Tissue Bank and clinical operations.
Reports to: Head of Scientific Operations
Salary
Key Responsibilities
- Acting as an ambassador for BioGrad’s Quality Management System (QMS), with oversight of all existing quality policies and processes including issue management, document control, change control, and external provider management. This includes serving as the system administrator for the electronic QMS platform, RADAR.
- Conducting internal audits in line with regulatory requirements and internal schedules, preparing audit reports, and supporting follow-up actions to drive continuous improvement.
- Conducting product manufacturing reviews and supporting product release activities.
- Assisting in the integration of new quality standards and accreditations into BioGrad’s comprehensive Quality Management System.
- Providing expert guidance on the application and implementation of regulatory requirements, including HTA, CQC, and ISO 9001.
- Maintain up-to-date knowledge of regulatory standards, including HTA, ISO 9001, and CQC, ensuring continuous compliance.
- Champion BioGrad’s Quality Management System (QMS) across the organization, supporting staff at all levels through tailored workshops and training.
- Draft, update, and align quality policies and procedures in accordance with management directives and regulatory changes.
- Compile and present monthly KPI data and quality trend analyses as part of routine management reviews.
- Ensure controlled documents are regularly reviewed, accurately issued and communicated via the electronic QMS; facilitate relevant QA sessions.
- Conduct internal system audits, prepare detailed audit reports in line with ISO guidelines for internal auditors, and monitor action plans for continuous improvement.
- Track the progress of QMS-related actions and tasks; proactively engage with relevant staff to ensure timely completion and accountability.
- Collaborate with senior management to identify and implement process enhancements.
- Support the manufacturing team with the issuance and control of documentation and labels necessary for production.
- Perform meticulous review and approval of batch production records, ensuring accuracy and regulatory compliance.
- Issue and authorize Batch Certificates of Analysis, ensuring all data meets required standards.
- Review supplementary documentation with a high level of attention to detail as required.
- Serve as administrator for the electronic QMS, onboarding new users and enhancing system functionality to support integration with other platforms.
- Continuously assess system use and propose improvements to enhance efficiency and user experience.
- Collaborate proactively with team members and cross-functional departments to ensure seamless operational workflows.
- Take initiative in managing tasks independently while maintaining clear communication with the line manager.
- Attend and contribute meaningfully to team meetings, offering suggestions for improvements and solutions.
- Stay abreast of regulatory changes, best practices, and quality trends to support professional development and ensure compliance.
- Act as a liaison between departments, ensuring clear communication and timely resolution of quality-related queries or issues.
Competency Criteria
Qualifications, Training & Knowledge
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Degree of Pharmacy or Scientific Degree – Essential
Application / Interview / Assessment -
Knowledge of ISO 9001 regulations and associated quality systems – Essential
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Evidence of continuous professional development ideally in relation to cell and gene therapy regulations – Desirable
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Familiarity with risk-based audit approaches and audit trail analysis – Desirable
Application / Interview / Assessment
Experience
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Experience or theoretical knowledge of internal auditing practices, as they pertain to full system audits – Essential
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Experience with quality assurance or quality control in a regulated environment (ideally GMP and HTA) regulations/guidelines – Essential
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Proven expertise of QMS management or management of individual QMS systems and activities such as risk management, document control, deviations etc. – Desirable
Application / Interview / Assessment
Circumstances
The post may from time to time require a flexible approach to working hours. – EssentialApplication / Interview / Assessment
Skills & Behaviors
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Immaculate attention to detail, with a strong ability to spot discrepancies, inconsistencies, and delays in task completion. – Essential
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Strong understanding of how cross-functional processes interlink within a quality management system (QMS). – Essential
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Proven ability to manage multiple tasks and competing deadlines in a fast-paced, regulated environment. – Essential
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Clear and concise communicator, capable of explaining expectations and timelines without ambiguity. Confident in asking probing questions and challenging existing practices respectfully and constructively. – Essential
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Adept at objective system assessment, identifying process gaps, and evaluating overall effectiveness. – Essential
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Skilled in conducting root cause analysis (RCA) and assessing the suitability of corrective and preventive actions (CAPA). – Essential
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Ability to write clear, concise, and evidence-based audit reports. – Essential
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Impartial and fair, committed to integrity—even when addressing sensitive or politically complex issues. – Essential
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Active listener who critically assesses verbal and non-verbal communication for deeper insight. – Essential
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Reliable in meeting schedules and deadlines, with confidence in reminding senior and junior colleagues about outstanding actions and communicating non-conformances diplomatically. – Essential
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Self-motivated and independent, capable of using initiative, solving problems, and achieving agreed objectives within set timelines. – Essential
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Commercially aware, with an understanding of the pressures and priorities in a regulated business environment, balancing operational needs with quality and compliance. – Essential
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Excellent interpersonal skills, comfortable engaging with regulatory authorities, stakeholders, and external agencies. – Essential
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Brings an enthusiastic and adaptable attitude to work, paired with a strong work ethic and commitment to excellence. – Essential
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Maintains a professional yet approachable demeanour, fostering trust and collaboration across all levels of an organization. – Essential
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