To contribute to SCR's quality governance framework and promote a strong culture of quality and compliance across all clinical trial and research site operations.
Working under the guidance of the Director of QA, this role manages key quality processes, supports risk mitigation and compliance oversight, and collaborates with cross-functional teams to maintain GCP compliance, regulatory adherence (e.g. FDA, EMA, TGA), and internal SOP requirements.
The Senior Quality Assurance Associate actively identifies and implements opportunities for continuous improvement to enhance operational efficiency and regulatory readiness.
Operational Compliance
* Proactively leads the maintenance, enhancement, and strategic development of the Quality Management System (QMS) to ensure clinical studies consistently meet internal quality standards and applicable regulatory requirements.
* Own the development, review, and implementation of Quality Documents (e.g., SOPs, policies, guidance), collaborating with cross-functional stakeholders and the Director of QA to drive process optimisation, regulatory compliance, and operational efficiency.
* Oversee equipment compliance activities, including maintenance, calibration, and verification, ensuring readiness for audits and inspections.
* Coordinate with, or serve as, the SCR Computer System Validation (CSV) Lead to plan and execute validation activities, manage change control processes, and ensure ongoing system compliance.
Audits and Inspections
* Lead the planning, coordination, and hosting of sponsor/CRO audits and regulatory inspections, ensuring SCR demonstrates compliance excellence.
* Direct the preparation of formal responses to audit/inspection findings, oversee root cause analyses, and ensure timely and effective CAPA implementation.
Regulatory Awareness and Compliance
* Interpret and apply evolving regulatory requirements, providing expert compliance guidance to clinical trial management staff.
* Serve as SCR's Research Governance Officer, reviewing and approving site-specific documentation for compliance.
* Champion privacy compliance and data protection practices in alignment with regulatory obligations, working in partnership with the CEO and Director of QA.
* Act as a senior GCP and GxP subject matter expert, supporting clinical study teams in achieving and maintaining the highest compliance standards.
Internal Audit Program
* Manage and execute SCR's internal audit program, including audit planning, risk assessments, compliance reviews, and follow-up actions to maintain regulatory readiness.
* Lead the assessment, qualification, and requalification of third-party vendors, ensuring service providers meet SCR's quality and regulatory requirements.
* Design and produce eQMS reports to track compliance metrics (training, deviations, quality events, CAPAs, change control), ensuring prompt resolution of issues and escalation of critical risks to the Director of QA.
* Provide senior-level support and advice on Quality Events, Deviations, Complaints, and Root Cause Analyses, ensuring CAPAs are effective, timely, and sustainable.
Quality Training & Development
* Design, deliver, and evaluate quality assurance training programs to strengthen regulatory knowledge, quality culture, and operational excellence across SCR teams.
Archiving
* Oversee the quality assurance aspects of Investigator Site File archiving and document lifecycle management, ensuring integrity, accessibility, and compliance.
Other Responsibilities
* Lead the technical aspects of onboarding and offboarding SCR personnel, including system access provisioning and eQMS/SiteDocs administration.
* Maintain up-to-date professional knowledge through targeted training, industry networking, and continuous personal development, ensuring skills align with SCR and global compliance expectations.
* Perform other duties as assigned by the Director Quality Assurance and/or SCR Manager to support organisational objectives.
Qualifications / Experience
* Bachelor's or advanced degree in life sciences, healthcare, or a related field.
* Minimum 3 years' experience within a QA role in a pharmaceutical, biotechnology CRO, or clinical research environment.
* Demonstrated experience in GCP and regulatory audits/inspections.
* Strong track record of working with eQMS and other clinical trial systems.
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