Austin Fraser is proud to be supporting one of the most exciting Biopharmaceutical companies in the world looking to hire a highly experienced and talented Inspection & Audit Manager to join the business in a newly-created role. Role purpose: In this role you'll have specific responsibility for overall regulatory, customer inspection and audit management. The brief will focus on leading, managing and overseeing regulatory inspections and customer audits and managing and supporting site leadership throughout the inspection/audit process to ensure optimal outcomes and a state of continuous inspection readiness. Providing a focal point for all inspection and audit-related activity and for coordinating follow-up and responses to observations, a key priority will be to improve the efficiency with which these activities are managed. As well as reviewing current practices, you'll be encouraged to collaborate with colleagues from across the wider business network to incorporate their learnings. You'll also need to build and maintain productive relationships with the Global Quality Assurance team to enhance knowledge sharing and improve response times. As custodian of good practice in this area, you'll be expected to take a lead role in ensuring follow up actions and responses remain focused and are managed in a timely way. A critical aspect of this will be to ensure that actions proposed are both appropriate and feasible, avoid 'scope creep' and can be delivered within the timescales committed. You'll need to establish strong relationships with key stakeholders across the site to ensure that these goals are continuously met. Key accountabilities: Manage regulatory inspections and customer audits for the site. Advise, guide and support the site in the overall inspection management Manage site preparation for inspections and audits Organise and run the Back Room during audits Manage any outcomes/findings, ensure appropriate responses liaising with customers and Global Quality Assurance Provide guidance for timely remediation and support response writing Work with QA and other departments to ensure that CAPA raised as a result of the above are SMART and that CAPAs are closed by the due dates. Responsible for leading the Site responses to Global regulatory gap analysis Prepare and review regulatory inspection evidence files QA Support: Support QP and QA management as required. Provide QA support to initiate, participate and contribute to PQS process improvements initiatives and projects. Apply GMP regulations consistently and use knowledge of GMP and quality processes to actively identify, suggest and participate in continuous improvement activities. To be successful in this role, you should have: Bachelors degree (or equivalent) in a scientific or QA-related discipline Significant experience working within QA roles in GMP-regulated pharmaceutical - ideally biologics or biopharmaceutical - environments Significant experience managing regulatory (e.g., MHRA & US FDA, etc.) inspections. Experience working with drug substances Excellent communication skills (verbal and written) Excellent risk based decision-making and problem solving skills. Accurate data entry skills. Attention to detail. Ability to meet strict deadlines. Ability to work in team and solo capacity. Significant experience in risk management and project management. You will be rewarded with a great salary and benefits, and genuine routes for progression in your longer-term career. If this sounds of interest please apply ASAP as my client is currently shortlisting for interview. Austin Fraser is acting as an Employment Agency in relation to this vacancy. Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status. Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.