Senior QC Compliance Specialist

R Dpartners; Shannon; On-site; EUR 85,000 - 110,000; Full time

Job summary

R Dpartners is seeking a senior Compliance Specialist to join its Quality Control function as a hands-on SME. You will provide quality leadership across GMP operations, including batch record review, deviation management, investigations, and regulatory compliance activities.

You will mentor colleagues across the QC team and drive data integrity and continuous improvement. The role requires extensive experience in QC/QA GMP environments, with biologics or ATMP exposure, and a track record of

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.

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 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.

Skills

QC compliance

Quality management

GMP documentation

Investigations & CAPAs

Leadership mentoring

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.

Key Competencies

• 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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