Senior QC Compliance Specialist

R&D Partners; Shannon; On-site; EUR 90,000 - 130,000; Full time

Job summary

R&D Partners in Ireland is seeking a seasoned Compliance Specialist to lead QC quality and regulatory compliance within GMP operations. This senior, hands-on role covers batch record review, deviations, investigations and ensuring right-first-time documentation.

You will mentor QC staff, drive quality metrics, support inspections readiness and collaborate with Manufacturing and QA. The successful candidate will bring extensive GMP experience in biologics/ATMPs and a proactive leadership style.

Qualifications

• Extensive experience in QC/QA within GMP-regulated environments.
• Proven track record in batch record review and GMP documentation.
• Experience leading investigations, deviations, CAPAs, and change controls.
• Strong knowledge of GMP, GDP, data integrity and QMS.
• Ability to mentor and guide QC teams.

Responsibilities

• Act as QC Compliance SME guiding QC colleagues and QC Managers.
• Review and approve QC documentation and batch records for timely release.
• Oversee OOS investigations, deviations, and root-cause analysis.
• Oversee CAPAs, change controls, and QMS records with timely closure.
• Provide technical guidance and mentoring to the QC team.
• Support data integrity, audit readiness, and continuous improvement.

Skills

QC compliance

GMP documentation

OOS investigations

CAPAs

Change controls

Data integrity

Team leadership

Collaboration

Biologics/ATMP

Job description

Join a dynamic team at a leading Contract Manufacturing Organisation and contribute to groundbreaking projects and cutting-edge solutions.

R&D Partners is currently partnering with a clinical-stage biotechnology organisation focused on gene therapy that is looking to appoint a seasoned Compliance Specialist to serve as a key subject matter expert within its Quality Control function. This senior, hands-on role will provide quality and compliance leadership across GMP operations, with responsibility for batch record review, deviation management, quality documentation, investigations, and regulatory compliance activities. The successful candidate will also play an important role in mentoring, supporting, and guiding colleagues across the wider quality team.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities

• Act as a QC Compliance SME, providing guidance and oversight to QC colleagues and working closely with QC Managers and Team Leads to maintain high standards of GMP compliance.
• Take ownership of the review and approval of QC documentation and batch records, ensuring accuracy, right-first-time documentation and timely GMP batch release.
• Oversee and drive OOS investigations, deviations and other quality investigations, supporting root-cause identification and ensuring effective and timely closure.
• Provide oversight of CAPAs, change controls and wider QMS records, ensuring actions are appropriately documented, progressed and completed within agreed timelines.
• Support the development of the wider QC team through technical guidance, training coordination, mentoring and day-to-day compliance leadership.
• Drive QC quality metrics, audit/inspection readiness, data integrity and continuous improvement, collaborating with Quality, Manufacturing and other cross-functional stakeholders.

Experience & Qualifications

• Several years' experience within a QC or QA GMP-regulated environment working with either biologics, or ATMPS.
• Strong experience reviewing and approving QC/manufacturing batch records and GMP documentation.
• Demonstrable experience managing OOS investigations, deviations, CAPAs, change controls and other quality records.
• Strong understanding of GMP, GDP, data integrity and Quality Management Systems.
• Previous experience providing technical leadership, mentoring or oversight within a laboratory/Quality environment would be highly desirable.
• Strong QC compliance and quality management expertise.
• Ability to take ownership of investigations and complex quality records through to closure.
• Biologics or ATMP product working experience
• Confident leadership and team-support capabilities.
• Excellent attention to detail and problem-solving skills.
• Strong planning, prioritisation and organisational abilities.
• Effective communicator comfortable working across multidisciplinary teams.

For more information, please contact Timi Asseez.

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