What you need to know
Matrix Recruitment Group are currently recruiting for a Senior Quality Manager for our client, a pharmaceutical biologics company, based in Dublin.
The Senior Quality Assurance Manager in collaboration with the Senior Vice President of quality have overall responsibility for management and oversight of the quality management system and for the establishment of all elements of the quality management system including GMP, GLP and GCP in support of clinical and commercial requirements.
Role is based remotely.
Your new job
Establish and maintain a QMS across all functions including GMP, GLP and GCP as required
Develop phase appropriate SOPs, policies and procedures working in accordance with relevant Standards and Regulations
Responsible for hosting QMS periodic reviews to monitor performance, effectiveness, continuous improvements and evaluate trends
Collaborate with cross functional management to drive process and system improvements and alignment
Oversee and manage the training program across all functional areas
Deliver training to various functions including GMP Induction, Annual GMP Training (site and supplier) and Training in QMS processes as required
Responsible for implementation and maintenance of the document management system
Review manufacturing and quality control records to ensure compliance with standards and regulations
Preparation, review and upkeep of product specification files in support of QP batch certification
Provide quality support on various GMP studies including process and analytical validations, stability studies, risk assessments as required
Responsible for the quality reviews and trending including review of CAPAs, OOS, Deviations, Customer Complaints and Change Requests and driving quality improvements across all areas
Manage the audit program including execution of internal and external audits
Responsible for drafting & upkeep of Quality & Technical agreements with GxP partners
Monitor and support risk management activities across all functional areas
Maintain knowledge of existing and emerging regulations industry related regulations, standards, or guidance documents and market requirements
What are we looking for?
Bachelor’s degree in a science area as well as any professional certification
Prior experience in pharmaceutical/biotechnology industry in a start-up environment, in a QxP/QP/role. (5-10 years relevant experience)
Knowledge of GMP/ GCP/ICH requirements and inspection readiness.
Experience in managing Quality Management systems to ensure GxP compliance.
A working knowledge of regulatory requirements that specifically apply for the manufacture and/or testing of Advanced Therapy Medicinal Products (ATMP products).
Experience in planning, managing and executing vendor and site audits, auditing key raw material suppliers as to GMP compliance.
Experience of working with different contract manufacturing companies.
Experience with continuous improvement or implementing new policies and processes.
Up to date knowledge of clinical trial regulations and guidelines.
Ensure all operational processes are compliant with regulations.
Documentation and data quality review to ensure compliance
Responsible for the overall management of Quality Management Systems and ensuring internal and external audits are scheduled and conducted in accordance with regulations.
Responsible for follow up of audit and issue CAPA's.
Proficient with planning and project management
Proficiency with Microsoft Products - Word, Excel, PowerPoint, Project, SharePoint, Teams, Zoom and other virtual platforms.
Apply for this job now via the link.
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