Description
Would you like to work for one of the largest CMO's in the world? Well, look no further as we may have the opportunity for you!We require a Quality Systems & Compliance Manager to join a global pharmaceutical company located in the South West UK for an initial 6-month duration.
Due to much internal investment and a number of exciting refurbishment projects in the pipeline this is a great chance to be involved in the full project life cycle with the opportunity to move into other projects and areas of this fast-paced and exciting business.
Role and Responsibilities:
- Implement and maintain a simple, robust, inspection ready and compliant Quality Management System (QMS).
- Ensure processes are defined and improved for all Quality Management Systems and Compliance activities.
- Administration and maintenance of all Quality Management Systems (eg Complaint, Deviations, CAPA and Change Control).
- Administration and maintenance of all Quality Management tools (eg Trackwise, eDMS and LMS).
- Management and oversight of the document control process from creation to obsoleting including archiving.
- Management and oversight of Quality Analytics: Ensure KPI's, targets and objectives are effectively monitored, trended, reported and shared with the sites leadership teams.
- Management and oversight of the sites Supplier and Vendor Assurance Program.
- Management and oversight of the sites Artwork process and activities.
- Management and oversight of sites Quality Agreements and APR/PQR.
- Management and oversight of Regulatory CMC activities, including ensuring site licenses are updated and compliance reports and pre-inspection compliance reports are submitted timely to the MHRA.
- Maintain thorough understanding of pertinent international regulatory guidance.
- Manage the implementation of continuous improvement programmes.
- Management of the Quality Systems & Compliance Team and all aspects of the people process including, hiring, on-boarding, mentoring, coaching, performance management and employee development.
- Science based degree eg. BSc or MSc
- 5-10 years' experience working in a pharmaceutical quality function, preferably sterile manufacturing.
- Substantial experience with defining and harmonising Quality Management Systems and with implementing the concepts, legislation, guidelines and requirements as set out in: UK Orange Guide , EU Eudralex Volume 4 , U.S. CFRs and other relevant regulations/guidelines.
- Experience with hosting and follow up on corporate audits, client audits and regulatory inspections.
- Minimum 5 years Leadership experience and demonstrated track record of creating high performance teams.
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