Overview
QC Microbiology Manager – responsible for overseeing QC microbiology activities at Grifols, a global leader in plasma‑derived medicines and transfusion medicine. The role supports a purification and aseptic manufacturing plant for the blood protein albumin and ensures GMP compliance throughout the QC process.
We are committed to equal employment opportunities that foster an inclusive environment. We proudly promote diversity, and are dedicated to providing a welcoming workplace for all employees and candidates.
Key Responsibilities
* Collaborate with QC chemistry, Incoming QC and cross‑functional teams to achieve departmental goals.
* Lead international project teams related to QC activities, including travel as required.
* Serve as the delegate for all QC Microbiology activities performed by the Quality Control Senior Manager.
* Notify relevant parties of issues and microbiology testing status to ensure timely escalation of any threats.
* Provide accurate quality performance information, monitor QC Microbiology metrics and KPIs, and interact regularly with other departments.
* Coordinate resources and cross‑functional activities to complete QC microbiology tasks within regulated timelines.
Laboratory Activities
* Manage the QC Microbiology team and supervise day‑to‑day tasks.
* Serve as subject matter expert on QC microbiology test methods, providing guidance and training.
* Oversee all QC microbiology operations, ensuring compliance with compendial and regulatory requirements.
* Maintain equipment and computerized systems, ensuring qualification, calibration, and preventative maintenance.
* Develop, review, and validate QC procedures and test methods.
* Verify and release microbiology test results for albumin process materials, including EM, water, raw materials, in‑process and finished products.
* Conduct technical reviews of data, support annual product quality reviews, and lead investigations of out‑of‑specification events.
* Identify and follow up corrective actions, manage CAPAs, and support audit/inspection programs.
* Collaborate on process change control, continuous improvement, and project initiatives across the Quality department.
* Provide flexibility for shift work when required.
Team Responsibilities
* Develop and train team members to meet business needs and regulatory standards.
* Set and monitor individual and team objectives, providing feedback and coaching.
* Recruit new staff as demand requires.
* Ensure adherence to safety and GMP requirements across the team.
* Implement process improvements and maintain awareness of regulatory changes.
Knowledge & Skills
* Extensive experience with microbiological techniques, troubleshooting, and data analysis.
* Strong analytical and decision‑making abilities.
* Competence in root‑cause investigation and report writing for OOS/OOT events.
* Excellent written and verbal communication in English; proficiency in Microsoft Office and SAP.
* Project management skills and the capacity to handle multiple deadlines.
* Knowledge of regulatory guidelines and experience in method transfer or validation is desirable.
* Minimum 5 years of QC experience with supervisory responsibilities in a quality environment.
* Experience in the analytical techniques used for biologics or protein therapeutics is advantageous.
Qualifications
* Bachelor’s degree in Microbiology, Biochemistry, or a closely related field.
* Minimum of 5 years of QC microbiology experience.
Benefits
* Highly competitive salary.
* Group pension scheme with company contribution matching.
* Private medical insurance.
* Career development opportunities in a rapidly expanding work environment.
* Succession planning and internal promotion pathways.
* Education allowance.
* Wellness activities, including social events.
Location
Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3
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