Senior Specialist Quality Assurance; COE

The Quality Center of Excellence (COE) Senior Specialist role will be involved in providing support for the Quality COE structure, ensuring the processes conform to our Company policies, and comply with cGMPs, Health Agency regulations, and all other applicable governing regulations, with the mission and ambition to manufacture breakthrough medicines from Ireland for patients around the world. Close collaboration with high-performance talent from our Company global team and the biotechnology industry to develop and execute multiple Quality Assurance systems and processes will be key, and the successful candidate will be a an individual and team member the future of our Company antibody drug conjugates and high potent compounds through a Quality culture that delivers unconstrained supply, that is Right First Time to patients worldwide.

As necessary and when applicable, provide training and guidance on the interpretation and implementation of our Company policies and regulatory requirements will also be key priorities for the Senior Specialist. Throughout the development of the new facility, the successful candidate will focus on commissioning, qualification, and/or validation of the facility, equipment, and process.

• Be responsible for the quality aspects of commissioning, qualification, and validation of facilities, utilities, manufacturing, packaging, labelling, and laboratories to ensure compliance with company policies, procedures, and regulatory expectations.
• Participate in quality-related activities for commissioning, qualification, and validation which are required by the Manufacturing Division Quality Manual or with potential for impact on product quality, patient safety, or data integrity.
• Collaborate closely with stakeholders and SMEs from site operations, quality operations, IT, automation, and engineering to provide evidence of quality input throughout the qualification and validation process and facilitate continuous improvement.
• Work on aspects of the project through URS, FAT, SAT, IC, OC, IQ, OQ, PPQ, and commercialization.
• Serve as the Quality contact for validation and ongoing qualification activities across the site including, but not limited to cleaning validation, utilities performance qualification, process validation, equipment requalification, new equipment installation.
• Provide quality oversight of the Lab on site and will ensure the Lab operates to Manufacturing Division Quality Manual requirements.
• Help support and maintain the Supplier Quality Management (SQM) process at the site.
• Understanding of the manufacturing process to ensure the equipment and facility are compliant with process needs and regulatory expectations.
• Knowledge of US and European cGMP guidelines, ICH, and other international regulatory requirements, as applicable to the site.

General:
This role requires an individual with a minimum of 5 years’ experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations, or Technical Operations. A self-starter and results-focussed, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.

Technical:
Must have at least 2 years of experience in commissioning, qualification, and validation activities in in a regulated environment. Must have at least 2 years of experience in a commercial QC Lab. Demonstrated knowledge of Cleaning in Place, Cleaning out of Place, Sanitize in Place. Demonstrated understanding of continuous quality / process improvement tools (As defined by the site, e.g., DMAIC, Lean QA, 5S etc.).

Exceptional analytical, problem solving & root-cause analysis skills. Ability to multi-task and handle…