Senior Quality Assurance Advisor

Responsibilities Plan, coordinate, execute and manage the global supplier qualification programme, ensuring the programme is risk-based, robust, justifiable and efficient. Maintain Resolian’s Global Supplier Database Action new supplier requests Assess new suppliers according to Resolian’s risk-based criteria Perform periodic supplier assessments as per Resolian’s schedule Monitor and report metrics on supplier sustainability Lead periodic meetings with high risk suppliers Lead the reporting of complaints and other supplier issues. Participate in external sponsor audits on matters related to supplier qualification and feedback comments into process improvements. Build effective relationships with suppliers and act as a point of focus for external communications. Liaise with clients and internal stakeholders in the preparation and execution of quality agreements. Maintain regulatory agency registrations (FDA, EMA, DUNS, etc) as required. Perform study, process and facility audits as required according to the audit program and study deadlines. Maintain a strong knowledge of the current regulations and guidance. Investigate and resolve supplier CAPAs. Work with QA and Operational teams across Resolian to enhance, improve and drive efficiencies across the group. Act as the contact point for client quality agreements, and regulatory agency registrations, ensuring documentation is accurate and current. Skills, Education & Qualifications Strong knowledge and understanding of working within a GxP or ISO regulated environment and their application. Demonstrable audit skills that can be practicably applied to auditing activities as a sole auditor or as part of a team. Experience of establishing audit scope and developing relevant audit schedules and checklists. An understanding of the function of the QMS and actively supporting QMS systems such as Deviations, OOS, Change Control and CAPA. Able to demonstrate strong customer (internal and external), supplier and regulator interaction skills. Experience working within the pharmaceutical industry is preferable. Minimum level of BSc in scientific field or recognised auditor certification, or equivalent industry experience