PROJECT MANAGER - BIOPHARMACEUTICAL FACILITY DEPLOYMENT

Bio Usawa Biotechnology Ltd is seeking an experienced Project Manager to lead the deployment and commissioning of our state-of-the-art modular biopharmaceutical manufacturing facility in Rwanda. This critical role will oversee the complete project lifecycle from site preparation through facility qualification and preparation for commercial manufacturing operations.

Application Process

Interested candidates should submit a comprehensive CV, cover letter detailing relevant experience, and three professional references (pdf format preferred). Please include specific examples of facility deployment projects and regulatory achievements.

Location

Based in Rwanda with travel to Ghana and Botswana

Key Responsibilities

Facility Development & Installation

• Manage site preparation activities to ensure readiness for modular unit installation
• Coordinate transportation logistics and customs clearance for modular units from USA to Rwanda
• Oversee facility installation, including utility connections, infrastructure setup, and integration
• Manage construction contractors, vendors, and technical specialists throughout the deployment

Regulatory Compliance & Permitting

• Lead acquisition of all necessary manufacturing permits and regulatory approvals in Rwanda
• Coordinate with Rwanda FDA, Ministry of Health, and other relevant regulatory bodies
• Ensure compliance with local building codes, environmental regulations, and safety standards
• Develop and maintain regulatory documentation and submission timelines

Equipment Qualification & Validation

• Plan and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols
• Oversee clean room qualification and environmental monitoring system validation
• Manage bioprocessing equipment installation, calibration, and qualification
• Coordinate with equipment vendors for technical support and warranty compliance
• Ensure all qualification activities meet international GMP standards

Project Management & Leadership

• Develop comprehensive project plans, timelines, and budgets
• Monitor project progress, identify risks, and implement mitigation strategies
• Provide regular progress reports to senior management and stakeholders
• Manage project budget and ensure cost-effective delivery

Stakeholder and Vendor Management

• Serve as the primary point of contact for vendors, government agencies, and internal teams.
• Report progress to senior management and key stakeholders.
• Foster collaboration between cross-functional teams (engineering, QA/QC, regulatory, operations).

Education & Experience

• Bachelor's degree in Engineering, Life Sciences, or related field; Master's preferred
• Minimum 8-10 years of experience in biopharmaceutical project management
• Proven track record of successful facility commissioning and qualification projects
• Experience with modular facility deployment and GMP manufacturing environments
• PMP Certification desirable

Technical Expertise

• Deep understanding of biopharmaceutical manufacturing processes and equipment
• Extensive knowledge of IQ/OQ/PQ protocols and validation procedures
• Familiarity with clean room design, HVAC systems, and environmental controls
• Understanding of cell culture processes and bioprocessing technologies
• Knowledge of international GMP standards (FDA, EMA, WHO)

Regulatory & Compliance

• Experience with regulatory submissions and permit acquisition processes
• Knowledge of pharmaceutical regulations in emerging markets preferred
• Familiarity with import/export procedures for pharmaceutical equipment

Leadership & Communication

• Strong project management skills with PMP certification preferred
• Excellent leadership and team management capabilities
• Outstanding communication and stakeholder management skills
• Ability to work effectively in multicultural environments
• Fluency in English required; French or Kinyarwanda advantageous