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Job Description
QC Senior Manager sought to lead Quality Control projects team in Dublin-based Biotech multinational, driving compliance, quality systems, and company objectives.
Responsibilities:
- Lead QC Shared Projects team to support manufacture, testing, and release of Drug Substance and Sterile Drug Product.
- Develop and implement Site Trending Program for Quality Control.
- Deliver QC Project portfolio in line with overall QC Strategic Objectives.
- Develop and implement continuous improvement initiatives to facilitate ongoing cost saving and performance excellence.
- Develop technical training structure and associated program to facilitate ongoing and consistent learning & development across the QC organization.
- Ensure audit readiness, both internal and external.
- Ensure 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.
- Minimum of 6 years experience in the Pharmaceutical Industry.
- Deep and demonstrated understanding and experience of the principles of GMP / GDP.
- Accomplished people manager with 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.