Job Title: Pharmaceutical Facility Manager
The Role of Pharmaceutical Facility Manager plays a pivotal part in the commercial operation of pharmaceutical manufacturing facilities. This professional oversees all qualification and validation activities necessary for facility readiness.
This individual is responsible for devising and implementing project management approaches to facilitate the execution of facility, equipment, and utility qualification (IQ/OQ/PQ) as per Good Manufacturing Practice (GMP) and regulatory requirements. They ensure that facilities are prepared for regulatory inspections and approvals from various health authorities.
Responsibilities
1. Project Management: Develops clear program overviews with key metric visibility to ensure effective management of facilities, equipment, utilities, computerized systems, and alternate source qualifications.
2. Qualification & Validation Management: Oversees the execution of facility, equipment, and utility qualification (IQ/OQ/PQ) based on GMP and regulatory expectations.
3. Regulatory & Compliance Oversight: Ensures facility compliance with FDA, EMA, and other health authority regulations.
4. Cross-functional Coordination: Aligns efforts across engineering, validation, manufacturing, quality, and supply chain to guarantee seamless transition into commercial operations.
5. Risk & Issue Management: Identifies potential qualification and validation risks and proactively develops mitigation strategies with relevant stakeholders to keep projects on track.
6. Stakeholder Engagement: Serves as the primary point of contact for internal stakeholders.
7. Budget & Resource Management: Monitors project budgets, optimizes resource allocation, and ensures cost-effective execution of programs.
8. Operational Readiness & Handover: Develops plans for training, process validation, and initial production batches to ensure the facility is ready for GMP operations.
9. Continuous Improvement: Implements best practices in facility qualification and validation to enhance efficiency and compliance.
Requirements:
* Educational Background: Bachelor's or Master's degree in Engineering (Mechanical, Chemical, Biomedical, Industrial, or related field).
* Certifications: PMP, Six Sigma Black Belt, Lean Manufacturing certified preferred.
* Regulatory Knowledge: Strong understanding of Annex I, US, and EMA GMP regulations, with practical experience in regulatory audits.
* Work Experience: Minimum 5 - 8 years of experience in pharmaceutical facility qualification, validation, or technical operations.
* Problem Solving Skills: Demonstrated ability to plan, design, and manage significant NPI and Tech Transfer projects.
* Communication Skills: Excellent communication, writing, presentation, and data organisation skills.
* Interpersonal Skills: Demonstrated interpersonal and leadership qualities.