location_onLondon, UK
watch_later Posted: Jun 17, 2024
Skills Required
Nice To Have skills
Job Description
We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
Key Responsibilities:
- Regulatory Compliance and Quality Oversight: Oversee compliance with applicable Regulations and Guidelines (primarily Good Clinical Practice) and provide quality oversight for staff working at the phase I Clinical Unit Cambridge (CUC) site. Ensure oversight of MHRA Phase 1 Accreditation Programme at CUC.
- Regulatory Agency Inspections: Accountable for coordination of Regulatory Agency inspections. Interacting directly with the Regulatory Agencies throughout the inspection process, conducting preparation activities with both CUC and other GSK functional lines and leading the inspection team during on-site inspections.
- Internal Audits: Accountable for coordination of internal audits conducted by Global Quality and Risk Management and Audit and Assurance. Interact directly with the auditors, providing input into the audit scope and host during on-site audits.
- Issue management: Coordinate, manage and lead investigations of significant deviations and issues. Lead and/or support root cause analysis activities and ensure subsequent corrective and preventative actions provide necessary remediation. Ensure appropriate escalation as per GSK global policies and processes.
- Risk management: Lead Risk Management activities at the CUC. Partner with enterprise risk management stakeholders to ensure appropriate escalation of significant risks as per GSK global policies and processes.
- Written standards and controls: Support the implementation of new standard operating procedures (SOPs). Lead procedural deviations management process and documentation of change controls.
- Management monitoring: Support Process Owners in the identification of appropriate controls for business activities and lead activities to track performance against these.
- Training: Identification of training needs to ensure quality and compliance.
Why you?
Basic Qualifications Skills:
- We are looking for professionals with these required skills to achieve our goals:
- Bachelor of Science or equivalent, or professional qualification in a life science field.
- Extensive knowledge and experience of ICH GCP Regulations, UK legislation and ethical requirements.
- Previous experience in a quality and/or Risk Management role.
- Experience working on phase 1 clinical trials.
- Influential and strong leadership skills; a proven record of personal accountability and delivering across multiple projects.
- Strong teamwork, collaboration with internal and external partners, and problem-solving skills.
Preferred Qualifications Skills:
- Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:
- Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience.
- Management of Pharmaceutical Quality Management Systems.
- Prior experience in a phase I Quality organisation.