
Quality Control Chemistry Manager
1d1 day agoGrifols
Dublin, IE · Full-time · €80,000 – €110,000
About this role
Join an international team at Grifols, a global healthcare company since 1909 improving health worldwide through plasma-derived medicines and transfusion solutions. Lead the Quality Control (QC) Chemistry Laboratory team in the purification and aseptic filling facility. Ensure high-quality testing of clean utility, raw material, in-process, and final container materials while maintaining cGMP and safety compliance.
Manage the QC Chemistry team to perform chemistry, immunochemistry, and protein testing per the production plan. Oversee laboratory data integrity, method qualification/validation, and equipment maintenance/calibration. Create, review, and update test methods and SOPs to meet regulatory and compendial requirements.
Drive process, product, OOS, and deviation investigations, implementing corrective and preventative actions. Represent QC Chemistry in regulatory, corporate, and internal audits, fostering quality interactions across departments and Grifols sites. Support site quality activities like Annual Product Quality Reviews and change control.
Maintain QC Chemistry metrics and KPIs, ensuring team training and development via performance management. Lead projects such as method transfers, process improvements, and harmonization. Act as delegate for the QC Senior Manager while keeping abreast of regulatory developments.
Requirements
- Full understanding of relevant cGMP, quality and compliance regulations
- Experience with chromatography instrumentation and methods
- Experience with protein chemistry instrumentation and methods
- Method Transfer and qualification experience
- Understanding of pharmacopoeial requirements and methods
- Excellent communication skills at organisation, team and individual levels
- Demonstrated problem solving skills
- Strong decision making skills
Responsibilities
- Manage the QC Chemistry team to carry out required chemistry, immunochemistry and protein testing
- Ensure QC testing of clean utility, raw material, in-process and final container materials is performed as per the production plan
- Manage integrity of Laboratory Data
- Ensure all methods are qualified/validated in line with site procedures and regulatory/compendial requirements
- Ensure all equipment is validated, maintained, calibrated, and requalified
- Drive and oversee process/product/OOS/deviation investigations
- Implementation of Corrective and Preventative Actions
- Maintain, monitor and report QC Chemistry metrics and KPIs
Benefits
- Join an international team working to improve the future of healthcare
- Diversity adds value to our business, our teams, and our culture
- Committed to equal employment opportunities that foster an inclusive environment
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