Job purpose
Reporting to the Senior Manager, Quality GCP, this role is responsible for ensuring that clinical trials are conducted in accordance with applicable regulatory requirements, ICH Good Clinical Practice (GCP) guidelines, and internal Standard Operating Procedures (SOPs). The position oversees core clinical quality assurance activities, including management of the GCP quality system, planning and execution of GCP audits, and support for regulatory authority inspections. The role also leads and coordinates inspection readiness efforts across clinical teams to maintain a state of continuous compliance and operational preparedness.
Main Responsibilities, Activities, Duties and Tasks
* Serve as the GCP Quality subject matter expert, providing compliance guidance and QA support to assigned clinical teams.
* Contribute to the development, implementation, and continuous improvement of GCP-related components of the Blue Earth Diagnostics Quality Management System (QMS).
* Support qualification and ongoing oversight of GCP service providers, including participation in due diligence assessments and vendor performance review activities.
* Plan, schedule, and conduct GCP audits (e.g., investigator sites, CROs, laboratories, and internal systems) in accordance with the approved GCP audit program.
* Lead coordination and execution of inspection readiness activities across clinical functions to ensure consistent preparedness and compliance.
* Support preparation, conduct, and follow-up activities for GCP regulatory inspections, ensuring adherence to applicable standards and expectations (e.g., FDA, EMA, MHRA, ICH-GCP).
* Author and manage GCP QA records, including change controls, deviations, and CAPAs, ensuring timely closure and appropriate documentation.
* Track and monitor audit, inspection, and self-identified CAPAs to completion, including verification of effectiveness checks.
* Develop, maintain, and revise SOPs, policies, work instructions, and training materials to reflect current regulatory requirements and industry best practices.
* Provide support to the Head of Quality Assurance in the execution of company-wide quality initiatives and continuous improvement activities.
Education
A degree in a science related discipline or greater than 5 years relevant industry experience.
Professional Experience, Knowledge & Technical Skills
* Minimum of 5 years of experience in Clinical Quality Assurance (GCP), including hands-on management of deviations, CAPAs, change controls, and use of electronic quality systems.
* Comprehensive knowledge of ICH GCP, and relevant regulatory requirements and guidances (e.g., FDA, EMA, MHRA).
* Qualified and experienced GCP auditor, with proven experience conducting investigator site, vendor, and system audits.
* Strong understanding of clinical study operations, documentation standards, and regulatory expectations throughout the clinical trial lifecycle.
* Demonstrated ability to exercise sound judgement and make independent quality and operational decisions within the regulatory framework.
* Experience supporting and/or participating in GCP Regulatory Authority inspections.
* Proven ability to write, review, and maintain clinical quality SOPs and controlled documents.
* Proficient in the use of Microsoft Office and electronic systems such as eQMS, eDMS, learning management systems, and eTMF.
* Ability to travel domestically and internationally as required (10–20%).
Soft Skills – Company Values & Behaviours
* Demonstrates strong attention to detail with a high level of accuracy and quality focus.
* Maintains the highest standards of integrity, ethics, and regulatory compliance.
* Highly organized, with the ability to prioritize effectively and adapt to changing business needs.
* Able to manage multiple projects and deadlines in a fast-paced, dynamic environment.
* Excellent problem-solving and critical thinking skills, with the ability to conduct clear, evidence-based investigations and write concise, well-structured reports.
* Strong written and verbal communication skills, with the ability to collaborate and build effective working relationships across all levels of the organization.
* Capable of influencing and gaining alignment among cross-functional and global stakeholders, establishing credibility quickly and constructively managing competing priorities.