Head of Quality Assurance
For one of our mid size virtual Biotech clients with a pipeline across both Small Molecule and Biologics covering Oncology and rare diseases.
Being responsible for Implementing and managing QA practices and processes to successfully integrate and manage new products from licensing transactions to commercial launch.
Ensure resource, process and system are ready for reviewing QC activities, batch reviews, change controls and deviations from third party vendors involved in the manufacturing, packaging and distribution of clinical materials
Ensure resource is available to release DS, DP and Packaged Drug Product for use in Clinical Studies.
Responsible for dealing with complaints from either clinical sites or patients. Initiating complaint investigations and implementing CAPA’s where required
Line managing the UK and US QA departments and take responsibility for all Quality activities related to the development and progression of said department to include; design, development, delivery and execution of the Global QA strategy including audit and inspection management, QMS management, GMP and GCP oversight.
Responsible for implementing good quality culture throughout the business
• Establish and maintain quality management system repository and framework, covering all GCP and GMP aspects of the Company's operations including, but not limited to:
• Ensuring implementation of Policies and Standard Operating Procedures for all aspects of GxP operations and GxP supporting systems, in collaboration with the process owners. This includes all aspects of the procedural document life-cycle e.g., coordination of SOP development; process mapping/development guidance, compliance review, SOP revisions and decommissioning.
• Implementation and maintenance of the QMS and other Quality Documentation repository.
• Identify and support GxP risk management in key risk areas, in cooperation with key stakeholders in the Company.
• Establish and maintain the Quality Assurance / Quality Management repository to support oversight of Quality within the organisation
• Define and maintain all aspects of the audit programme including, but not limited to; maintenance of the audit cycle, definition of the annual audit schedule, planning, conducting, reporting and follow up of audits (internal and vendor), oversight of audits contracted to consultants.
• Management of those engaged by Mereo to perform Quality activities, including F/T Quality Specialist, Quality contractors, and/or vendors.
• Implementation of GCP, GMP and related compliance and quality training
• Cooperating with the Head of IT and System Owners to ensure appropriate validation of regulated systems and controls.
• Collaboration with the Head of Pharmaceutical Development, Head of Clinical Operations and Chief Medical Officer (CMO) to ensure ongoing quality support for all GxP operations.
• Periodic quality review with the Executive Management Team to ensure the continued suitability and commitment to continuous quality improvement in line with the Company’s Policy.
Skills & Experience
• Minimum Bachelors’ Degree (preferably scientific discipline)
• Must have strong GCP and GMP experience plus experience of other GxPs,
• Overall Quality Assurance System Maintenance and ability to define and drive quality strategy
• Minimum 6 years’ auditing experience, primarily vendor and trial site auditing
• Strong risk and change-management skills