QC Senior Engineer

QC Senior Manager 

We are actively seeking to recruit QC Senior Manager to become a key member of the projects team within a Dublin based Biotech multinational. This position has responsibility for the learning & development management, QC Trending Management and execution of Continuous Improvement projects.
Responsibilities
• Leadership of QC Shared Projects team to support manufacture, testing and release of Drug Substance and Sterile Drug Product.
• Responsible for the Site Trending Program for Quality Control
• Responsible for delivering the QC Project portfolio in line with the overall QC Strategic Objectives
• Responsible for delivering continuous improvement initiatives to facilitate ongoing cost saving and performance excellence
• Develop a technical training structure and associated program to facilitate ongoing and consistent learning & development across the QC organization in line with the QC Network Strategy
• Ensures audit readiness, both internal and external
• Ensures the QC Projects Team operates in compliance with company policies and directives, evolving Health Authority regulations and expectations.
network to drive compliance, strengthen quality systems and support company objectives.
• Responsible for coaching, developing staff and completion of performance appraisal reviews.
• Support QC planning and scheduling activities as required.

Qualifications & Experience
• Bachelor/Masters in Science or Science related discipline and have a minimum of 6 years’ experience in the Pharmaceutical Industry.
• Deep and demonstrated understanding and experience of the principles of GMP / GDP
• An accomplished people manager with the ability to motivate and develop departmental staff through effective feedback and coaching
• proven success working well in a team environment, as well as proven leadership skills to manage a team of professionals through changing business needs.
• Experience with interacting with regulatory agencies.
• Knowledge of US and EMA GMP regulations and guidance.
• Demonstrated leadership, interpersonal, communication, and motivation skills.
• Demonstrated understanding of test methods and instrumentation associated with the testing of biopharmaceutical processes including chemistry and microbiological testing.