My client, a pharma company who develop innovative Neurology drugs, seek an experienced GVP Lead to join their friendly team. Reporting to the Head of QA, this person will support all aspects of clinical compliance and quality management activities from a Pharmacovigilance perspective, including document review, internal systems review and oversight of external site and vendor audits and follow up.
They will also review and assess quality metric trends e.g. from audits, to ensure that satisfactory CAPA plans are established. They will use their expertise to provide guidance on quality matters to the company, ensuring that appropriate systems, processes and procedures are in place which comply with applicable regulations, and to study and company requirements.
This is an immediate employment opportunity, and could be on a full-time or part-time (75%) basis. The office is in Aberdeen, but this role can be remote, working from home with monthly trips to the office (with travel and accommodation costs paid by the company).
- Act at Pharmacovigilance Subject Matter Expert to contribute to the maintenance of a comprehensive GxP compliant quality programme.
- Participate in setting the annual internal, vendor and project audit schedules.
- Oversee or conduct document audits, internal system audits, vendor audits and investigator site audits to assess compliance with study protocols and cGxP, and act as QA audit manager for selected audits.
- Oversee contract auditors, providing first line of communication.
- Manage CAPA plans and follow up via an appropriate system and/or database.
- Oversee Quality Issue management, ensuring escalated issues are appropriately recorded, followed through to successful resolution and the outcomes reported.
- Participate in the coordination and hosting of Competent Authority facility inspections of the company
- Initiate, write, review, approve and, update of QMS documents e.g. policies, SOPs and associated documents, to support the Company QMS.
- Maintain awareness of and integrate current and new GxP regulations and requirements into company systems, processes and procedures.
- Review vendor QMS documents to ensure consistency with regulatory and company requirements.
- Provide routine and ad-hoc consultancy to company employees on GVP
- Provide feedback and suggestions for process improvement to ensure process efficiency and effectiveness.
- Degree in science, nursing or a life sciences degree
- Considerable pharmaceutical or allied industry experience (8 years minimum), including direct pharmacovigilance experience.
- Subject matter expertise in GVP UK/EU/FDA regulations and working knowledge of GCP/ICH, EMA and FDA regulations and guidelines and how these interface with each other
- Commitment and ability to handle high workloads and deadlines
- Experience in working in a company with marketed products and IMPs advantageous
- Regulatory inspection experience (hosting/participant/interviewee) advantageous.
- Team player with strong communication and negotiation skills
- Ability to prioritise workload and commitment to meeting deadlines
- Ability to make decisions, evaluate risks, propose innovative solutions, and define and execute action plans
- Experience which enables ability to work with little instruction, in an office or remote environment.
My client offers a competitive salary, negotiable based on experience, excellent working conditions and a fulfilling and rewarding career, with plenty of opportunities for further development.
If you have the essential skills required and would like to discuss the full detail of the Job Description, required competencies, and remuneration, please contact Kayleigh on 01293 364095, or apply with your CV to arrange a confidential discussion.