About the job
Fastnet Executive Search as excited to partner with our long-standing pharmaceutical client to appoint a Head of Quality in 2026. The successful candidate will be accountable for leading and developing the Quality function at their Cork based manufacturing facility, ensuring full compliance with cGMP, regulatory requirements, and corporate standards. This pivotal role spans Quality Assurance, Quality Control, EHS, and Validation, and will be instrumental in supporting an ongoing major site expansion project, ensuring that quality is embedded across all phases of growth.
As a member of both the Site Leadership Team and the Global Quality Team, the Head of Quality will contribute to shaping site and corporate strategy, drive a culture of continuous improvement, and provide leadership to cross-functional teams.
Key Responsibilities
Strategic & Leadership
- Lead, coach, and develop high-performing QA, QC, EHS, and Validation teams.
- Act as a key member of the Site Leadership Team, contributing to site-wide decision-making, operational planning, and strategic development.
- Serve as the quality interface between the site and the Global Quality, ensuring alignment on policies, standards, and objectives.
- Build and sustain a strong quality culture focused on accountability, collaboration, and compliance.
- Represent Quality in all major project planning and execution activities, including a significant site expansion and new product introductions.
Quality Assurance
- Oversee all QA operations, including batch release, deviation and CAPA management, quality systems, documentation, and audits.
- Ensure effective GMP compliance aligned with regulatory standards (e.g. HPRA).
- Lead internal and external audits and regulatory inspections, acting as site quality representative.
Quality Control
- Ensure laboratory operations are compliant, efficient, and capable of supporting both routine manufacturing and project needs.
- Drive analytical method validation and transfer in collaboration with R&D and technical teams.
- Ensure laboratory data integrity, timely release testing, and continuous improvements in QC processes.
Validation
- Provide strategic oversight of site validation activities, including equipment, processes, cleaning, and computer systems validation.
- Ensure validation strategies align with lifecycle principles and support new manufacturing capabilities arising from the expansion project.
EHS (Environment, Health & Safety)
- Champion a safety-first culture across the site.
- Ensure compliance with local and global EHS regulations and company standards.
- Lead initiatives to minimize environmental impact and promote sustainability.
Project Support & Expansion
- Act as Quality lead for the site’s expansion project, ensuring that new facilities, equipment, and systems meet all applicable regulatory and corporate quality standards.
- Support capital project planning, risk assessments, commissioning, and qualification activities.
- Support readiness activities for new production lines and technology transfers.
Qualifications & Experience
- Degree in Science or related life science field.
- Minimum of 5 years’ experience in pharmaceutical manufacturing, in a senior Quality leadership role.
- Strong working knowledge of API manufacturing processes, cGMP, ICH guidelines, and regulatory requirements.
- Proven experience leading multi-disciplinary teams (QA, QC, Validation, EHS).
- Experience supporting large-scale capital projects and/or site expansions.
- Prior exposure to inspections by major health authorities (e.g. HPRA).
- Advanced training in leadership, lean manufacturing, or quality systems.
Core Competencies & Attributes
- Leadership: People-focused leader with a track record of building high-performing teams.
- Strategic Thinking: Ability to align quality initiatives with long-term business and operational goals.
- Communication: Excellent communicator across all levels, with the ability to influence and drive cross-functional collaboration.
- Decision-Making: Strong analytical skills with sound judgment and risk-based decision-making.
- Change Management: Comfortable leading through complexity and change, particularly in a growing and evolving environment.
This is a unique opportunity to shape the future of a growing API manufacturing site, contribute to a transformative expansion project, and play a critical role in elevating quality standards within a global organisation.
The Head of Quality will not only safeguard compliance but will be empowered to drive innovation, operational excellence, and cultural transformation.
