Clinical Quality Assurance Manager

About the role

The owns the end-to-end quality strategy and execution for global clinical operations, ensuring that all activities align with the highest standards of GCP and regulatory compliance. This role is responsible for managing the daily operations of the Clinical Quality team, including workload planning, prioritization, and performance management of team members to drive efficiency and effectiveness. The manager will act as the functional leader and strategic quality advisor for GCP quality activities, influencing decision-making across global clinical operations and operational departments to embed quality into every process. A core responsibility is the oversight of the entire Quality Management System (QMS), managing records such as deviations, non-conformances, complaints, protocol deviations, CAPAs, change controls, risk assessments, and other quality events to ensure integrity and traceability. The manager will review and approve investigations, ensuring they are robust, risk-assessed, completed within timelines, and supported by appropriate corrective and preventive actions to prevent recurrence. By monitoring CAPA effectiveness, inspection trends, quality metrics, KPIs, and emerging compliance risks, the role will identify systemic improvement opportunities and develop actionable mitigation strategies. The manager will also provide quality oversight for decentralized clinical trial activities, covering nursing services, home healthcare, investigational product handling, source documentation, and patient-facing clinical processes to ensure consistency and compliance. Leading quality oversight for new services, processes, vendors, systems, operational changes, computerized system validation, equipment qualification, and process validation activities is essential to maintaining GCP integrity across the business. This includes owning the quality review of all clinical trial documentation, such as protocols, ICFs, eCRFs, Pharmacy Manuals, Monitoring Plans, essential documents, and other applicable GCP materials to ensure accuracy and compliance. The role will manage vendor qualification and oversight, conducting quality risk assessments, audits, periodic requalification, managing Quality Technical Agreements, and ongoing performance monitoring to ensure vendor standards are met. Additionally, the manager will lead Sponsor audits, regulatory inspections, licensing authority inspections, and client qualification audits, overseeing inspection readiness, documentation review, audit response development, and commitment tracking to ensure timely and effective resolution. Ultimately, the role will drive continuous improvement across the QMS, updating documentation, enhancing quality governance, applying risk-based decision-making, fostering stakeholder collaboration, and promoting a proactive culture of quality, compliance, patient safety, and operational excellence across the organization.

Key facts

What you'll do

• Manage day-to-day Clinical Quality team activities, including workload planning, prioritization, performance management, coaching, training, and professional development to ensure team effectiveness and alignment with business objectives.
• Provide cross-functional oversight of the GCP Quality Management System to ensure strict compliance with applicable regulations, Sponsor requirements, and internal company procedures, identifying gaps and driving corrective actions.
• Serve as the functional leader and strategic quality advisor for GCP quality activities across global clinical operations and operational departments, translating quality strategy into actionable plans.
• Oversee QMS records comprehensively, including deviations, non-conformances, complaints, protocol deviations, CAPAs, change controls, risk assessments, and quality events to maintain accurate and up-to-date documentation.
• Review and approve investigations systematically, ensuring they are robust, risk-assessed, completed within timelines, and supported by appropriate corrective and preventive actions that address root causes.
• Monitor CAPA effectiveness, inspection trends, quality metrics, KPIs, and emerging compliance risks to identify systemic improvement opportunities and develop mitigation strategies that enhance quality performance.
• Provide quality oversight for decentralized clinical trial activities, including nursing services, home healthcare, investigational product handling, source documentation, and patient-facing clinical processes to ensure consistency and regulatory adherence.
• Lead quality oversight for new services, processes, vendors, systems, operational changes, computerized system validation, equipment qualification, and process validation activities that impact GCP operations and compliance.
• Oversee quality reviews of clinical trial documentation, including protocols, ICFs, eCRFs, Pharmacy Manuals, Monitoring Plans, essential documents, and other applicable GCP materials to ensure accuracy, completeness, and compliance.
• Support vendor qualification and oversight by conducting quality risk assessments, audits, periodic requalification, managing Quality Technical Agreements, and monitoring ongoing vendor performance to ensure standards are maintained.
• Lead Sponsor audits, regulatory inspections, licensing authority inspections, and client qualification audits, managing inspection readiness, documentation review, audit responses, and commitment tracking to ensure timely resolution.
• Drive continuous improvement initiatives by updating QMS documentation, enhancing quality governance, applying risk-based decision-making, fostering stakeholder collaboration, and promoting a proactive culture of quality, compliance, patient safety, and operational excellence.
• You will What You'll Need: demonstrating a strong commitment to quality and compliance by meeting all eligibility criteria and hard requirements outlined for the role.
• Bachelor's Degree or higher with a preference for concentrations in pharmaceutical sciences, life sciences, or engineering to ensure a strong technical foundation for quality management responsibilities.
• You will possess years' experience in a Clinical Quality related role, demonstrating a proven track record in managing quality activities within regulated environments.
• Minimum 2-3 years of people leadership or supervisory experience is preferred, showing the ability to guide, develop, and motivate a team effectively.
• Experience within a CRO, pharmaceutical, biotechnology, healthcare, or other regulated clinical environment is required to understand the complexities of clinical trial quality management.
• Demonstrated experience supporting global clinical trials and decentralized clinical trial activities, including oversight of remote and site-level operations.
• Experience leading Sponsor audits, regulatory inspections, internal audits, and/or supplier audits, ensuring thorough preparation and effective follow-up on findings.
• Practical experience leading quality investigations, CAPAs, root cause analyses, and quality risk assessments to drive systemic improvements and compliance.
• Experience with eQMS, eTMF, Microsoft Office, and quality management software applications to manage documentation, workflows, and data efficiently.
• Strong knowledge of ICH E6(R3), FDA, EU CTR, MHRA, GCP, GDPR where applicable, and other global regulatory expectations to ensure audits and inspections are handled competently.
• Strong understanding of risk-based quality management, computerized system validation, validation lifecycle principles, and GDP/clinical trial supply logistics where applicable to manage quality processes effectively.
• Ability to manage multiple quality activities in a fast-paced global environment with strong organization, project management, and attention to detail to meet tight deadlines and priorities.
• Strong communication, analytical, stakeholder management, and influencing skills, with the ability to work effectively with Sponsors, auditors, inspectors, vendors, senior leadership, and cross-functional teams to ensure alignment and compliance.

Skills & tools

You will use go to perform various operational and quality management tasks within the platform, leveraging its capabilities to support clinical trial processes and quality oversight.

Practical notes

Note: This role requires occasional travel to support audit and inspection readiness activities as required by Sponsor and regulatory requirements, although the primary engagement is remote. The position is based in the United States, and candidates must be eligible to work in the US without sponsorship. The start date is dependent on business needs and candidate availability, with a requirement to meet strict timelines for onboarding and project commitments.