Job Description
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. Skills: QC Manager Projects Biotech Quality Control