Head, Affiliate Process Training & Systems, Hertfordshire
Russell Oakley is recruiting for a Head, Affiliate Process Training & Systems to join a research focussed healthcare company at their site based in Welwyn Garden City on a permanent basis.The main purpose of the role will be to provide direction, leadership and expertise in all GCP compliance activities to the Affiliate Process, Training and Systems group. The role is accountable for ensuring all GCP governed clinical activities in CCO are delivered to the highest standards of quality and efficiency in accordance with company and industry requirements and regulations. The APT manager leads quality and compliance excellence within the local CCO organisation by embedding quality principles throughout the organization, across all clinical studies conducted within the affiliate.Responsibilities will include:- Accountable for management of CCO UK quality activities, including compliance checks, local CAPA documentation and follow-up and local GCP/GVP metrics in order to effectively manage risk in the affiliate.- Leadership of CCO for GCP audits and inspections, accountable for ensuring the CCO affiliate is GCP-inspection ready and acts as the Single Point of Contact for audits/inspections- Accountable for management of CCO UK quality activities, including compliance checks, local CAPA documentation and follow-up and local GCP/GVP metrics in order to effectively manage risk in the affiliate- Proactively identifies opportunities for continuous quality improvement and ensures effective knowledge and best practice sharing within and outside APT- Lead the implementation of relevant global, regional and local initiatives, as required- Leadership in recommending, writing, approving and implementing improvements to relevant GCP procedural documents, processes and/or tools to ensure optimal quality standards and efficiency- Accountable for development and delivery of global, regional, and local training on procedural documents and business processes, as required; Ensure, through effective collaboration and metrics, that affiliate employees are appropriately trained on all relevant local/regional/global processesIn order to be considered for this role, you will be required to have the following qualifications, skills and experience:- University degree or equivalent; preferably in a medical/science-related field- Extensive experience in GCP, with experience of clinical research/development in multiple therapeutic areas or in Clinical Quality Assurance- Proven project management skills to work with a variety of different systems and stakeholders and deliver commitments on time and with quality- Previous experience managing change - Effectively manages change; explaining the context, answering questions, and patiently listening to concerns- Availability to travel domestically and internationally if requiredPlease note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL41117 in all correspondence.