CSV Team Lead

Alexander Mann Solutions (AMS) is the world's leading provider of Talent Acquisition and Management Services. We deliver award-winning solutions to over 65 outsourcing clients and consulting services to hundreds more. Our Contingent Workforce Solutions (CWS) service acts as an extension of our clients' recruitment team and provides professional interim and temporary resources. Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people at Sanofi are dedicated to make a difference on patients' daily life, wherever they live and enable them to enjoy a healthier life. On behalf of this organisation, AMS are looking for a CSV Team Lead for a 12 Month contract based in Haverhill. Purpose of the Role: Provides leadership and management of the CSV team to meet defined priorities and the overall objectives of the department Is responsible for coordinating and for providing validation expertise in the lifecycle management of all aspects of computer system validation, qualification, data integrity activities at Haverhill. Ensures compliance of validated computerised systems with requirements set forth in relevant procedures as per GAMP and cGMP. Ensures approval of qualification or validation protocols and reports for computerised systems. As a CSV Team Lead you will be responsible for: Manages the performance of individuals and the overall team to meet defined priorities and objectives Actively develops team members technical ability, productivity and key competencies Manages priorities for individuals and team, and addresses conflicts as necessary Understands the stakeholders for the role and team and meets their communication and performance requirements and expectations Fosters and develops a culture of safe working and safety best practice within own team and the department Develops an environment of trust, openness and collaboration within team and department Provides support and guidance to Haverhill site projects and operations to meet the quality and compliance requirements of the site and the wider company with respect to CSV. Reviews and approves validation deliverables and provides guidance in their creation. Identifies compliance gaps within their own area of responsibility and proactively works towards their remediation. Keeps up to date on regulations and global quality documents updates with respect to CSV and evaluates the impact on site activities. Maintains a constant state of inspection readiness within area of responsibility and contributes to this process across the department Supports all site audits (internal, and third parties) and inspections both directly and indirectly Drives a culture of continuous improvement within direct team and the wider department Maintains Validation systems and processes to the standards of the Sanofi Quality Documentation Is the pyramid owner for CSV documents Identifies and highlights quality risks and actively participates in their resolution Reviews and oversites of qualification and validation for timeliness, content and conclusions Takes ownership and manages all Phenix entities relating to direct group (events, CAPA, CCs etc) Ensures own and teams training records are complete and up to date Maintains local computer system inventory and CSV sharepoint. Manages scheduling of Periodic and Security Reviews and ensuring adherence to these schedules. May supervise other staff and contractors as required to manage workload. Ensures HSE risk assessments are in place and regularly reviewed for all team activities What we require from the candidate: Strong knowledge of working within a Quality Management System and cGMP and experience of working within a cGMP environment High level of qualification/validation knowledge Ability to develop good relationships with customers and stakeholders Experience of working within a quality role Strong written and verbal communication skills Ability to motivate, engage and develop individual team members Awareness of statistical analysis techniques and software and ongoing development of knowledge in this area Understanding of data integrity principles Understanding of current industry requirements of cGMP, Annex 11, GAMP, 21 CFR Part 11. Experience of working on GAMP related projectsfor multiple aspects of IT and/or process control systems. Current regulatory knowledge in the field of computer systems validation If you are interested in applying for this position and meet the criteria outlined above, please click the link to apply and we will contact you with an update in due course. Alexander Mann Solutions, a Recruitment Process Outsourcing Company, may in the delivery of some of its services be deemed to operate as an Employment Agency or an Employment Business This job was originally posted as www.totaljobs.com/job/89895200