Quality Assurance Manager
Salary: Dependent on experience
An exciting opportunity to join an expanding Biotech who specialise in pioneering new treatments within severe liver disease and oncology. My client are recruiting a Quality Assurance Manager to have responsibility of defining a Quality Management System to encompass all relevant company activities, provide advice and support to companies development teams with regards to management of quality issues and build and ensure a culture of quality throughout the organisation. You will also work closely with the CEO, Clinical Operations Director and Laboratory Manager to monitor the performance of GXP with regards to quality standards required to support the organisations activities. The successful incumbent will also be responsible for delivery GxP training, planning, conducting and reporting GxP audits and represent the organisation during regulatory audits.
Responsibilities (to include, but not limited to):
• Assist in developing, coordinating and managing the configuration and implementation of quality systems and technologies.
• Ensure deviations from batch records, protocols, sample analysis plans or SOPs are documented and properly authorised.
• Ensure quality activities are carried out according to regulatory requirements and company guidelines.
• Monitor and author standard operating procedures (SOPs) as required.
• Maintain all documents, protocols and plans including archival.
• Track investigation and resolution of Corrective and Preventative Actions and deviations.
• Plan, conduct and report external audits and study audits to assess compliance with Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP).
• Represent company during internal audits and regulatory inspections.
• Evaluate vendors to assure compliance to required regulations and project needs.
• Provide GxP training and guidance to staff and new starters.
• Proven track record of monitoring and influencing the quality performance of contracted service providers, including external audit experience.
• 5+ years of related Quality Assurance experience in biotech or pharma industry.
• Comprehensive knowledge of GCP Requirements.
• Proven track record of monitoring and influencing internal client group quality compliance, including self-inspection audits.
• Basic understanding of GLP and GMP requirements.
• Experience in the design and management of a quality system.
• Proven track record in defining, implementing and maintaining Quality Management Systems for biotechnology or biopharma companies.
• Substantial experience of managing quality issues in a biotechnology or biopharma setting.
• In-depth knowledge of GCP and related industry/regulatory guidelines governing clinical trials in the UK, EU and USA.
• Excellent communication skills.
• Excellent negotiation and influencing skills.
• Conversant with quality requirements of EU Directives and ICH guidelines.
• Knowledge of cGMP and related industry/regulatory guidelines.
If however, you do not feel that this is the right role for you, please forward these details on as we have a generous referral scheme in place.
Please note due to the high level of applications if you are not contacted within a week, you have not been successful on this occasion.
Please note, you must be eligible to work in the UK.
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- Quality Assurance Manager