Senior Quality Assurance Manager

3 days ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €60,000 - €80,000

Job Title: Senior Quality Assurance Manager

About the Position

This is a senior role responsible for ensuring compliance with regulatory requirements, industry standards, and company policies related to qualification, validation, and quality assurance in a pharmaceutical manufacturing environment.

Main Responsibilities
  • Quality Assurance & Compliance:
    • Ensure adherence to GMP (Good Manufacturing Practices), FDA, EMA, ICH, and other global regulatory guidelines.
    • Develop, implement, and oversee quality systems related to validation, qualification, and change control.
  • Validation & Qualification Management:
    • Lead the development and execution of IQ/OQ/PQ protocols for equipment, utilities, facilities, and computerized systems.
    • Oversee process validation, cleaning validation, method validation, and continued process verification.
  • Leadership & Cross-Functional Collaboration:
    • Provide technical leadership and mentorship to QA, validation, and production teams.
    • Serve as a liaison between Quality, Manufacturing, Engineering, and Regulatory Affairs as required to ensure alignment on validation strategies.
  • Documentation & Data Integrity:
    • Ensure accurate and complete documentation in compliance with Good Documentation Practices (GDP).
    • Maintain data integrity standards and ensure compliance with 21 CFR Part 11 and Annex 11 for computerized system validation.
  • Root Cause & Risk Analysis:
    • Conduct root cause analysis (RCA) for deviations, non-conformances, and validation failures to implement effective corrective actions.
    • Perform risk assessments and apply risk management tools (e.g., FMEA, HACCP) to proactively identify and mitigate potential quality and compliance risks.
Requirements
  • Education: Bachelor's or Master's degree in Pharmaceutical Sciences, Engineering, Chemistry, Biology, or a related field.
  • Experience: 4+ years experience in pharmaceutical or biotech manufacturing with a strong focus on validation, qualification, and quality management.
  • Equipment, facility, and utility qualification (HVAC, Fridges and Freezers and temperature controlled storage areas etc.).
  • Computerized system validation (CSV) and data integrity compliance.
  • GMP compliance, risk-based validation approaches, and regulatory audits.
  • Managing QMS, writing and maintaining SOPs and work instructions.
  • Performing root cause analysis, risk management, and CAPA investigations.
  • Technical Skills: Proficiency in FDA, EMA, ICH Q7-Q10, ISO 9001, and EU GMP Annex 11 and 15 validation requirements.
  • Soft Skills: Strong leadership, communication, problem-solving, and project management skills.

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