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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