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