QC Manager

PQE Group; Dungarvan; On-site; EUR 90,000 - 130,000; Full time

Job summary

PQE Group is seeking an experienced Quality Control (QC) Manager to lead a 50-person QC laboratory in Dungarvan on an interim basis. You will drive strategic direction, oversee operations, and ensure compliance with GMP, GLP and data integrity standards while fostering cross-functional collaboration across manufacturing, QA and supply chain.

The role requires a strong leadership track record, extensive knowledge of analytical methods, and proven capability to manage large teams in a regulated

Qualifications

• Education: Bachelor's or Master's degree in Chemistry, Pharmacy, Biology, Biochemistry, Microbiology, or a related field.
• Experience: 5+ years in a pharmaceutical QC environment; 3+ years in leadership.
• Leadership: Proven ability to lead large teams (30+) in a complex lab.
• Regulatory knowledge: deep knowledge of cGMP, GLP, data integrity, FDA/EU GMP, ICH.
• Technical: Strong understanding of analytical and microbiological methods (HPLC, GC, Dissolution, Environmental Monitoring).
• Problem solving: Skilled in investigations and CAPA implementation.
• Communication: Excellent stakeholder management.

Responsibilities

• Lead, coach and mentor a large team of QC Analysts, supervisors and specialists to foster a high-performance culture.
• Provide strategic and technical leadership for the QC department and align with site goals.
• Drive continuous improvement, implement new technologies, workflows, and procedures to enhance efficiency and reduce costs.
• Oversee daily laboratory operations for analytical and microbiological testing and timely release of products.
• Manage resource planning, scheduling, and budget to meet lead-time targets.
• Ensure compliance with cGMP, GLP, data integrity and regulatory requirements; maintain documentation and systems.
• Lead audits and inspections readiness; drive CAPAs and robust investigations.

Skills

Team Leadership

Strategic Direction

Change Management

Lab Operations

Quality Systems

Regulatory Knowledge

Analytical Methods

CAPA Investigations

Cross-functional Collaboration

Communication

Education

Bachelor's or Master's in Chemistry, Pharmacy, Biology, Biochemistry, Microbiology

Tools

LIMS

SAP

Job description

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.

We are seeking an experienced and strategic Quality Control (QC) Manager to lead our complex and highly regulated QC laboratory in Dungarvan on an interim basis. In this critical role, you will be responsible for providing leadership, direction, and operational oversight for a team of approximately 50 QC professionals, ensuring the lab operates to the highest standards of GMP, GLP, and data integrity.

This is a leadership role that requires a blend of strategic vision and hands‑on operational management. You will be accountable for the timely and compliant release of raw materials, intermediates, and finished pharmaceutical products while driving a culture of continuous improvement and cross‑functional collaboration.

Key Responsibilities

Leadership & Strategy

• Team Leadership: Lead, coach, and mentor a large and diverse team of QC Analysts, supervisors, and specialists. Foster a high‑performance culture focused on quality, accountability, and professional development
• Strategic Direction: Provide strategic and technical leadership for the QC department, aligning laboratory objectives with overall site and business goals. Develop and execute plans to optimize laboratory operations and capabilities
• Change Management: Drive transformation and continuous improvement initiatives within the lab, implementing new technologies, workflows, and procedures to enhance efficiency and reduce costs

Operational Management

• Laboratory Oversight: Manage all aspects of daily laboratory operations, including analytical and microbiological testing, to ensure the accurate and timely release of products
• Resource Planning: Oversee resource allocation, work scheduling, and budget management to ensure the QC function operates efficiently and meets lead‑time targets
• Compliance: Ensure full compliance with all relevant cGMP, GLP, Data Integrity (ALCOA+), EHS, and other international regulatory requirements
• Documentation & Quality Systems: Oversee the review and approval of analytical reports, SOPs, and QC documentation. Ensure robust use and maintenance of site electronic systems such as LIMS and VQMS

Cross‑Functional & Stakeholder Management

• Collaboration: Partner effectively with cross‑functional teams, including Manufacturing, QA, Supply Chain, and other internal departments to align quality goals and resolve issues
• Audit & Inspection: Lead the QC team in preparation for and during external regulatory agency audits and internal audits. Ensure the laboratory is in a constant state of inspection readiness
• Investigation & CAPA: Champion investigations into quality incidents, non‑conformances, and out‑of‑specification (OOS) results, driving robust root cause analysis and implementation of effective CAPAs

Qualifications & Experience

Essential

• Education: Bachelor's or Master's degree in Chemistry, Pharmacy, Biology, Biochemistry, Microbiology, or a related scientific field.
• Experience: Significant experience (typically 5+ years) in a Quality Control environment within the pharmaceutical, biotech, or healthcare industry, with at least 3+ years in a leadership/management role.
• Leadership: Proven track record of leading, developing, and managing large teams (30+ employees) in a complex laboratory setting.
• Regulatory Knowledge: Deep and current knowledge of cGMP, GLP, data integrity principles, and relevant regulatory standards (e.g., FDA, EU GMP, ICH)
• Technical Expertise: Strong understanding of a wide range of analytical and microbiological testing methods and instrumentation (e.g., HPLC, GC, Dissolution, environmental monitoring)
• Problem Solving: Strong problem‑solving and decision‑making skills, with experience leading technical investigations and implementing CAPAs
• Communication: Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence at all levels of the organization.

Desirable

• Experience with Laboratory Information Management Systems (LIMS) and SAP.
• Experience in a consumer health or OTC pharmaceutical environment.
• Previous experience in a fixed‑term or interim leadership role.

Next steps

Upon receiving your application, if a match is found, the Talent Acquisition department will contact you for an initial HR interview. If there is a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal. Alternatively, if the feedback is negative, we will contact you to halt the recruitment process.

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.