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
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