Job Title: Senior Manager, Quality Control Laboratories
Location: Mayo
Overview
We are seeking a Senior Manager of Quality Control Laboratories to lead our QC operations on a fixed-term basis. This role involves strategic oversight, planning, and management of laboratory activities, ensuring compliance with global regulatory standards and alignment with business objectives. The position supports the Quality leadership team in achieving site operational and compliance goals.
Key Responsibilities
- Provide leadership, direction, and development to QC teams, ensuring resources and capacity align with business and project needs.
- Develop and implement departmental strategy, goals, and budgets to support site and global objectives.
- Oversee all laboratory operations, ensuring compliance with GMP, GLP, FDA, EMA, and HPRA requirements, as well as environmental and safety standards.
- Represent the organisation during client audits, regulatory inspections, and technical meetings.
- Lead quality risk management and continuous improvement initiatives to enhance laboratory efficiency and compliance.
- Drive the implementation of new technologies, analytical methods, and systems within QC to support new product introduction and lifecycle management.
- Ensure robust systems are in place for data integrity, documentation control, and laboratory investigations.
- Act as decision-maker for critical quality events, deviations, and out-of-specification (OOS) investigations, ensuring timely closure and effective CAPAs.
- Collaborate cross-functionally with QA, Manufacturing, Regulatory Affairs, and Technical Services to support business continuity and new product launches.
- Develop and deliver training programs to strengthen QC capabilities and foster a culture of quality excellence.
- Oversee vendor and contract laboratory relationships, ensuring external testing and services meet compliance and quality expectations.
- Report on key quality metrics and performance indicators to senior site and global leadership.
- Ensure laboratory equipment is qualified, calibrated, and maintained according to regulatory and internal standards.
- Champion a culture of safety, compliance, and continuous learning within the QC function.
Qualifications & Experience
- Bachelor's degree (minimum) in Pharmaceutical Science, Chemistry, Biotechnology, or related discipline. Advanced degree preferred.
- Extensive experience in a senior QC or Quality leadership role within pharmaceuticals, biopharma, or a similarly regulated industry.
- Proven track record of managing large laboratory teams and complex operations.
- Strong knowledge of GMP, GLP, regulatory frameworks, and international compliance standards.
- Demonstrated ability to lead inspections, engage with regulatory agencies, and manage external stakeholders.
- Strong financial and budgetary management skills.
- Excellent communication, conflict resolution, and stakeholder management skills.
- Strategic mindset with the ability to drive change and innovation while maintaining compliance.
