Job Description

We are seeking a highly motivated and experienced Project Manager to lead and support an Annex 1 remediation project. The successful candidate will oversee the execution of the defined backlog of work, ensuring compliance with regulatory standards and successful delivery of project milestones.

This role demands excellent project management skills, knowledge of micro or sterile engineering, and ideally exposure to Health Authority inspections and requirements.

Key Responsibilities Project Planning & Execution: Develop, maintain, and execute project plans aligned with the defined backlog of work. Monitor project progress and ensure timely delivery of milestones. Identify and mitigate risks to ensure smooth project execution.

Stakeholder Management: Collaborate with cross-functional teams, including Quality, Engineering, Regulatory Affairs, and Manufacturing, to ensure alignment with project goals. Serve as the primary point of contact for internal and external stakeholders. Communicate project status, challenges, and successes to senior leadership and stakeholders.

Regulatory Compliance: Ensure all project activities align with Annex 1 requirements and other applicable regulatory standards. Support documentation efforts to ensure regulatory compliance and readiness for Health Authority inspections.

Budget & Resource Management: Manage project budgets, ensuring cost-effectiveness while maintaining quality standards. Allocate resources effectively and identify needs or gaps to ensure successful project delivery.

Process Improvement: Drive continuous improvement initiatives during project implementation to enhance processes and compliance. Identify and implement best practices in sterile manufacturing and engineering.

Qualifications & Experience Essential:

• Proven experience as a Project Manager, preferably in the pharmaceutical, biotech, or healthcare industry.
• Strong knowledge of project management methodologies, tools, and techniques.
• Experience managing complex projects with multiple stakeholders.
• Familiarity with sterile or microbiological engineering principles.

Preferred:

• Experience with Annex 1 remediation or related regulatory projects.
• Exposure to Health Authority inspections and regulatory interactions.
• Certification in project management (e.g., PMP, PRINCE2).
• Knowledge of cleanroom design, aseptic manufacturing processes, and validation practices.

Personal Attributes

• Detail-oriented and highly organized.
• Proactive and adaptable to dynamic project environments.
• Strong leadership and interpersonal skills to motivate and manage cross-functional teams.
• Ability to work under pressure and meet tight deadlines while maintaining quality standards.