Senior Compliance Specialist

Are you a compliance expert ready to take ownership of quality, supplier management, and regulatory excellence in a critical, high-impact role?

R&D Partners is seeking a Senior Compliance Specialist to join our team. In this role, you will ensure that supplier management, internal audits, and regulatory compliance activities are conducted in line with industry standards and company policies. You will also support supply chain processes, oversee contract manufacturers, and assist with batch release activities. This position plays a key role in maintaining quality and driving continuous improvement.

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

Responsibilities:

• Manage vendor notifications, complaints, and quality defect reporting systems.
• Lead investigations, identify root causes, and implement corrective actions.
• Oversee supplier and contract manufacturer documentation and compliance.
• Support the preparation and review of documents for batch release.
• Coordinate local regulatory activities, including maintaining site master files and manufacturing authorizations.
• Manage the supplier quality system, including quality agreements and periodic reviews.
• Prepare for regulatory audits and corporate visits, ensuring readiness and compliance.
• Conduct self-inspections and internal audits, addressing findings with corrective actions.
• Assist in drafting, reviewing, and approving compliance-related documents such as SOPs, change controls, and reports.
• Provide training to new and existing staff on compliance-related topics.
• Participate in or lead compliance projects as needed.

Key Skills and Requirements:

• A degree in a science or quality-related field, with a Qualified Person (QP) certification.
• Strong knowledge of EU GMP, US FDA, and other relevant regulations, particularly for oral solid, sterile, and combination products.
• Excellent problem-solving skills and attention to detail.
• Strong written and verbal communication skills, with proficiency in English.
• Ability to work independently and collaboratively in a fast-paced environment.
• Familiarity with data integrity and good documentation practices.
• Must be eligible to work in Ireland.

For more information, please contact Billy O’Brien.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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