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Job Description
An exciting opportunity has arisen for a QC Lead, Microbiology at our state-of-the-art biologics facility in Dunboyne, County Meath, Ireland. This leadership role involves managing laboratory start-up activities, New Product Introduction, Micro Analytical Technology Transfer, and Quality Control (QC) testing. The primary responsibility is to support the Quality Control testing function.
Key Responsibilities Include:
Coordinate and oversee the microbiology laboratory team activities.
Support technical transfer of products, including Method Transfer/Validation, contamination control, aseptic training, environmental monitoring, raw materials testing, product testing, in-processing testing, process validation, and facility validation.
Translate company and site vision and goals to the Quality team.
Lead the Microbiology QC team through effective influence, collaboration, and teamwork.
Apply troubleshooting and problem-solving skills; coach and mentor teams through complex issues.
Promote continuous improvement and challenge the status quo.
Utilize lean tools and build lean capabilities within teams.
Support organizational change with good change management practices.
Foster talent development through active coaching and creating a learning organization.
Collaborate with Quality Risk Management (QRM) to ensure a ‘right first time’ culture in QC for quality excellence.
Drive a safety culture where everyone owns safety.
Your Profile:
Degree in Science, Quality, or Technical disciplines.
Experience in biotechnology and/or pharmaceutical industry with proven accomplishments.
Leadership experience managing teams and laboratories.
Excellent communication and presentation skills for stakeholder engagement.
Deep understanding of cGMP, GMP, ICH, USP regulations, especially analytical method development and validation.
Logical thinking and proactive under pressure.
Self-motivated and flexible.
Ability to manage multiple priorities and escalate issues appropriately.
Knowledge of Quality Management Systems and continuous improvement tools like Six Sigma.
We prioritize patient-centric solutions and embrace diversity and inclusion to foster innovation. If you’re ready to impact healthcare and push scientific boundaries, apply today.
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