OVERALL ROLE OBJECTIVE
The GCP QA Manager is responsible for implementing and maintaining Good Clinical Practice (GCP) compliance programs to support the clinical trial activities at TC BioPharm.
The post holder will work with and support the Clinical and Quality teams to ensure operational excellence and to exercise overall responsibility for compliance of clinical development at TC BioPharm with GCP.
Based at their manufacturing facility in the central belt of Scotland, the GCP QA Manager will join TC BioPharm Ltd (TCB), a fast growing, immunotherapy company developing cell-based treatments for cancer patients; moreover, our unique culture, values and working environment attracts, retains, and inspires people to give their best.
RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
The GCP QA Manager will:
- provide QA oversight to ensure clinical trial activities are conducted in compliance with applicable regulations, ICH GCP guidelines, and internal policies and procedures
- manage and conduct internal, investigational site and supplier audits
- host client audits, and serve as the point of contact and host for all regulatory inspections
- promote a GCP compliant environment with internal and external stakeholders while ensuring established quality systems are employed
- assure successful outcomes of client audits and regulatory inspections by managing the sites’ compliance status, proactively identifying and working collaboratively to resolve compliance risks, and maintaining an effective GCP quality system
- serve as audit host for client audits and regulatory inspections.
- lead the resolution of and response, as required, to any audit/inspection findings.
- effectively communicate audit and inspection outcomes to clinical team and Executive Management
- perform detailed review of policies, procedures, work instructions, quality issues, CAPAs, vendor management documents. and other essential documents
- assure the control of documents is maintained so only current, approved versions are accessible to personnel
- assure periodic review of procedures and work instructions
- assure all clinical documents, internal, 3rd party and vendor audit records, and study-related documents are appropriately archived
- identify, communicate, and escalate risks, study violations, and serious non-compliance situations
- provide direction for and assure appropriate and timely resolution of violations and non-compliances, acting always with an appropriate sense of urgency
- assure timely issuance of corrective and preventive actions (CAPAs) in response to quality issues and audit observations
- monitor completion of CAPAs to assure thorough root cause investigations, appropriate and effective actions and timely execution
- assure GCP training programs are established, implemented, and maintained for all relevant personnel
- continuously remain up to date with the latest industry changes to regulatory requirements and industry standards
- represent GCP Quality Assurance on TC BioPharm compliance-related projects and initiatives, and where assigned, lead such projects and initiatives.
- perform other duties as assigned.
- Bachelors in a scientific or life sciences discipline. A healthcare background and/or an advance degree preferred.
SKILLS & EXPERIENCE
- A minimum of 3 years of relevant and increasingly responsible experience in the Biotech/Pharmaceutical Industry in a GCP quality role is essential
- A minimum of 2 years of experience in clinical trial monitoring is essential
- Clinical trial audit experience is essential.
- Knowledge of applicable Global GCP regulations, Good Clinical Practices, ICH Guidelines is essential.
- Demonstrated audit conduct experience is essential, including experience supporting regulatory authority inspections.
- Excellent oral and written communication skills.
- Strong root cause analysis/problem solving, risk assessment and impact analysis abilities.
- Excellent communication, negotiation, conflict management, and cross-functional facilitation skills.
- Proficient with MS Office
- Excellent written/oral communication and interpersonal skills
- Excellent Microsoft Office skills
- Thorough approach and high attention to detail
- Strong time management and organisational skills
If you are looking to work within a challenging, dynamic, and rewarding environment, then TCB represents an excellent career move. This is an opportunity to be part of a growing, ambitious business where people development is critical to future success. As we continue to expand, there will be career opportunities on a truly global scale.
TCB is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.
Together with a competitive salary, we offer a comprehensive range of benefits and an excellent working environment.
Full-time, permanent role, working 37.5 hours per week Monday to Friday.