Project Manager

5 days ago

Limerick, Limerick, Ireland beBeeRegulatory Full time €55,000 - €75,000
Job Title:

Project Manager in Regulatory Compliance


About the Role:

This is a critical liaison position between client teams and the Global Facility Delivery group in a highly regulated biopharmaceutical environment. The successful candidate will be responsible for effective communication, compliance with quality and Health & Safety policies, and project delivery.


Main Responsibilities:
  1. Communication Facilitation: Serve as the primary point of contact between client stakeholders and the GFD team, ensuring all expectations, updates, and requirements are clearly communicated and documented.
  2. Meeting Coordination: Schedule, organize, and lead regular meetings to drive project progress, capture action items, and ensure alignment across teams.
  3. Change Control Management: Initiate, coordinate, and track change control processes in accordance with internal and regulatory requirements. Ensure all change controls are properly documented, assessed for impact, and executed with stakeholder buy-in.
  4. Document Review and Scheduling: Oversee the scheduling and execution of document reviews, ensuring timely completion and submission of technical, quality, and compliance documentation. Track document status and proactively follow up to mitigate delays.
  5. Quality Assurance: Maintain stringent adherence to all quality policies and procedures. Work closely with Quality Assurance teams to ensure project deliverables meet or exceed regulatory and internal standards.
  6. Health & Safety Compliance: Ensure comprehensive compliance with Health & Safety regulations and policies. Champion a safety-first culture in all project activities.
  7. Risk Management: Identify, assess, and escalate risks related to compliance, schedule, or project execution. Support the development of mitigation strategies in collaboration with relevant stakeholders.
  8. Continuous Improvement: Seek opportunities to enhance processes and workflows between the client and GFD, driving efficiency while maintaining compliance and quality standards.

Key Qualifications:
  • Bachelor's degree in Engineering or equivalent experience in the biopharmaceutical or pharmaceutical sector.
  • Minimum of 3 years' experience working in highly regulated environments, preferably in biopharmaceutical manufacturing or facility delivery.
  • Proven experience managing change controls and working with document management systems in a GxP environment.
  • Strong understanding of quality management systems (QMS), good manufacturing practice (GMP), and health & safety regulations relevant to biopharmaceutical operations.
  • Excellent organizational, time management, and communication skills.

Core Attributes:
  • Collaboration: Demonstrates a diplomatic approach to engaging stakeholders from diverse functional backgrounds.
  • Accountability: Takes ownership for meeting schedules, documentation deadlines, and compliance obligations.
  • Adaptability: Comfortable managing competing priorities and adapting to rapidly changing project demands.
  • Integrity: Upholds the highest standards of honesty, confidentiality, and regulatory compliance.

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