Job Description
QC Senior Manager We are actively seeking to recruit a QC Senior Manager to become a key member of the projects team within a Dublin based Biotech multinational.
This position has responsibility for 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.Deliver the QC Project portfolio in line with the overall QC Strategic Objectives.
Deliver 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.
Ensure audit readiness, both internal and external.Ensure the QC Projects Team operates in compliance with company policies and directives, evolving Health Authority regulations and expectations.
Coach, develop staff and complete performance appraisal reviews.
Support QC planning and scheduling activities as required.
Qualifications & Experience Bachelor/Masters in Science or Science related discipline with 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.
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