Senior Quality Systems and Compliance Specialist

Quality Systems and Compliance Specialist (Senior)
AMC21217
Contract – 6 months
Co. Meath


We’re currently recruiting for an exciting opportunity with a Biopharmaceutical organization based in Co. Meath. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


Join the dynamic team at the Research & Development Division facility as a vital member of the Global Development Quality Assurance team. In this role, you'll play a pivotal part in ensuring the highest standards of quality and compliance across our operations.

Key Responsibilities:

• Collaborate daily with cross-functional teams to address compliance issues and meet project milestones effectively.
• Lead and participate in investigations of deviations, risk assessments, and changes, ensuring timely implementation of appropriate actions.
• Review and approve Change Controls, Deviations/CAPAs, SOPs, and related documentation for compliance with GMP and site requirements.
• Provide oversight to GMP readiness, technical transfers, regulatory approvals, and clinical operations.
• Contribute to the development of training materials and provide subject matter expertise (SME) training on Quality Assurance SOPs as needed.
• Assist in the creation and maintenance of QA SOPs, metrics, and reports to meet site requirements.
• Identify and implement efficiencies and quality improvements to foster a culture of continuous improvement.
• Foster strong relationships with management and colleagues to promote a safe and compliant environment.
• Ensure timely escalation of compliance risks to management.

• Bachelor’s degree or higher in Science, Quality, or a related field.
• 4-5 years of experience in Quality Assurance, Quality Control, or Technical Operations in the biological and/or pharmaceutical industry.
• Proficiency in QRM, SQM, Deviations, and Change Control processes, with experience in investigations and problem-solving.
• Strong attention to detail and precision in preparing and reviewing GMP documentation.
• Excellent written and verbal communication skills.
• Ability to think logically and be proactive in a startup environment.
• Team player with the ability to work independently.
• Familiarity with quality management systems such as Veeva, SAP, PAS-X, Delta V, Trackwise, etc.
• Knowledge of FDA, HPRA, EMEA, and other regulatory requirements related to Biologics and/or Pharmaceuticals.

• Experience in direct interactions with regulatory agencies during site inspections.
• Previous experience in a sterile/low bioburden environment.