About CYTE:
CYTE is a full-service cardiovascular contract research organisation (CRO) powered by a global site network. We provide research solutions to our Pharma and Biotech clients and CRO partners via: CYTE Locate, our global site network comprising nearly 3,100 sites in 45 countries led by our global and national study leaders; CYTE Connect, our integrated clinical platform that allows seamless collaboration for sites, sponsors and CROs; and CYTE Accelerate, our specialist CRO services.
Role Overview:
CYTE is seeking a QA & Compliance Manager to lead and continuously strengthen our quality and compliance framework across all project activities. This role is responsible for the hands-on implementation and oversight of CYTE’s Quality Management System, ensuring compliance with applicable regulatory requirements, industry standards and sponsor expectations.
The QA & Compliance Manager will provide practical guidance to study teams, proactively manage risk, oversee audits and inspections and drive continuous improvement. Acting as a key partner to operational teams and senior leadership, the role offers a unique opportunity to undertake additional responsibilities and play an important part in supporting the wider Clinical Operations team. This may include activities beyond QA and Compliance, as directed by project managers. We are seeking someone with proven compliance experience and experience supporting clinical trials from an operational perspective, or someone with extensive compliance experience within a CRO environment who is keen to develop and contribute in this area.
Overview of Key Responsibilities and Duties:
Quality Management System (QMS)
* Develop, implement and maintain CYTE’s Quality Management System (QMS), including the quality policy and end-to-end quality processes
* Identify quality system gaps and lead the development, review and implementation of SOPs, policies, templates and guidance documents
* Ensure effective document control, version management and archiving across all quality and clinical documentation
Risk Management & Oversight
* Own the clinical risk management framework, including maintenance of the risk register
* Proactively identify, assess and escalate emerging or unmitigated risks, ensuring clear and effective mitigation plans
* Periodically review procedures, reports and operational practices to identify hidden risks or non-conformities
Quality Assurance & Compliance
* Ensure compliance with GCP, applicable regulatory requirements, internal SOPs and client-specific requirements
* Investigate, assess and classify reported quality issues, deviations and non-conformances
* Facilitate root cause analysis (RCA) sessions with CYTE study teams
* Develop, implement and track Corrective and Preventive Action (CAPA) plans, ensuring effectiveness and timely closure
Audits, Inspections & Continuous Improvement
* Lead the internal clinical audit and quality improvement programme, ensuring findings are addressed and sustained improvements are implemented
* Support and coordinate external client audits and regulatory inspections, including preparation, conduct and follow-up
Training & Quality Culture
* Support staff training, onboarding and ongoing engagement with the QMS
* Promote a strong quality and compliance culture across CYTE
* Provide guidance and coaching to study teams on operational quality, risk management and regulatory compliance
Regulatory Intelligence & Reporting
* Maintain awareness of evolving regulatory requirements, industry standards and best practices relevant to CRO operations
* Translate regulatory changes into practical operational guidance for the business
* Prepare and present quality, compliance and risk reports to senior management and external regulatory bodies as required
Data Protection & Governance
* Act as Data Protection Officer (DPO) for CYTE, ensuring compliance with applicable data protection legislation
* Oversee data privacy governance, incident management and staff awareness across the company
* Take ownership of additional data protection–related duties as required
Vendor & Partner Oversight
* Provide QA oversight of CRO partners, vendors and third-party service providers
* Review vendor deliverables for quality and regulatory compliance
This role also provides a unique opportunity to support the wider Clinical Operations team with activities outside of QA and Compliance, as directed by project managers.
Qualifications and Experience:
* Bachelor’s degree in Life Sciences, Pharmacy, Medicine, Quality Management, or a related discipline
* Advanced degree or professional qualification in Quality, Regulatory Affairs, or Clinical Research preferred, not essential
* 10+ years of experience in clinical research, including 5+ years in Quality Assurance and Compliance within a CRO or pharmaceutical (within clinical trials)
* Experience working on observational studies is desirable
* Demonstrated experience developing, implementing and maintaining a Quality Management System (QMS) in a regulated clinical research setting
* Strong working knowledge of ICH-GCP, ISO standards and applicable global regulatory requirements
* Proven experience managing clinical audits, vendor audits and regulatory inspections
* Hands-on experience investigating quality issues, deviations and non-conformances, including leading root cause analysis and CAPA development
* Experience assessing and managing compliance risks related to new services, technologies or business initiatives
* Demonstrated experience providing QA guidance and oversight to cross-functional clinical teams
* Prior experience acting as, or supporting, a Data Protection Officer (DPO) role and ensuring compliance with data protection legislation (e.g. GDPR) preferred
* Experience developing and delivering quality and compliance training programs
* Proven ability to work both hands-on operationally and at a strategic level
Benefits and Salary:
* Competitive salary
* Hybrid working
* Full autonomy to make an impact within a small team, with full support to succeed
* 34 days of paid leave (including public holidays)
* 6% employer pension contribution
* Income protection and life assurance
* Private health insurance and dental benefits (post-probation)