Company profile: Our client is a leading global biopharmaceutical organization with a strong presence in Ireland.
They are committed to delivering innovative medicines that improve and extend patients' lives worldwide.
The company fosters a culture of excellence, collaboration, and continuous improvement, while placing a strong emphasis on quality, compliance, and employee development.
Job Summary: Our client is currently seeking an experienced QC Systems Lead Investigator to join their Quality Control Shared Services team on a 12-month contract basis.
Reporting to the QC Shared Services Manager, this role will play a critical part in supporting QC operations through the management of investigations and change controls within a regulated GMP environment.
The successful candidate will act as a subject matter expert for QC investigations, working closely with cross-functional stakeholders to ensure timely, compliant, and high-quality outcomes.
Responsibilities: Lead and manage assigned QC investigations to closure Facilitate root cause analysis and structured problem-solving sessions Author, review, and complete high-quality investigation reports Define and implement CAPAs, effectiveness reviews, and supplemental tasks Present investigation outcomes at Investigation Review Boards (IRB) to senior management Lead and coordinate the initiation, implementation, and closure of QC change controls Ensure timely completion of all quality system activities in line with GMP requirements Collate metrics and KPIs and generate dashboard reports Communicate effectively with local and global stakeholders Lead huddles, meetings, and conference calls, providing clear read-outs and updates Support Operational Excellence (OpEx) initiatives and continuous improvement activities Participate in internal and external audits Provide support to additional QC Shared Services activities as required Requirements: Bachelor's degree (minimum) in Biochemistry or a related scientific discipline At least 3 years' experience working in a GMP laboratory environment, ideally within biologics Minimum of 1 year's experience working with quality systems (Investigations / Change Controls) in an FDA and EMA regulated environment (e.g. TrackWise, Infinity) Previous QC investigations experience is highly advantageous Knowledge of biologics QC testing (e.g. separations, bioanalytical, microbiology, raw materials, stability) is desirable Strong problem-solving and project management capabilities Excellent technical writing, organisational, and time-management skills Strong communication and collaboration skills, with the ability to work effectively across multiple levels of the organisation Ability to quickly learn and understand new assays, processes, and investigation areas Why You Should Apply Opportunity to contribute to therapies that help patients in the fight against serious diseases Work within a high-performing, quality-driven biopharmaceutical environment Gain valuable experience within a globally recognised organisation Be part of a company culture that values diversity, innovation, leadership development, and employee well-being #LI-PC2