HEAD OF QUALITY ASSURANCE

The Head of Quality Assurance will lead the establishment and implementation of comprehensive quality systems for our monoclonal antibody manufacturing operations. This senior leadership role requires extensive experience in biopharmaceutical quality assurance, regulatory compliance, and team leadership. The successful candidate will be responsible for ensuring all products meet international quality standards while establishing quality culture and processes from the ground up.

Application Process

Interested candidates should submit a comprehensive application including:

• Detailed CV highlighting relevant biotechnology quality experience
• Cover letter outlining motivation for joining Bio Usawa Biotechnology
• Three professional references from biotechnology/pharmaceutical industry

Location

Rwanda

Employment Type

Full-time, Permanent

Key Responsibilities

Quality System Development & Implementation

• Design, develop, and implement comprehensive Quality Management Systems (QMS) compliant with ICH guidelines, US-FDA, EMA, and relevant African regulatory requirements
• Establish and maintain Standard Operating Procedures (SOPs) for all quality-related activities
• Develop quality policies, procedures, and work instructions for monoclonal antibody manufacturing processes
• Implement risk management frameworks including Quality Risk Management (QRM) principles

Regulatory Compliance & Liaison

• Ensure compliance with Good Manufacturing Practice (GMP) requirements for biotechnology products
• Serve as primary liaison with regulatory authorities including Rwanda FDA and other African regulatory bodies
• Support regulatory submissions, inspections, and audit responses
• Maintain current knowledge of evolving regulatory landscape across target African markets

Quality Control & Assurance Operations

• Oversee analytical testing programs for raw materials, in-process samples, and finished products
• Establish specifications, test methods, and acceptance criteria for monoclonal antibody products
• Implement robust batch release procedures and certificate of analysis protocols
• Manage deviation investigations, CAPA (Corrective and Preventive Action) systems, and change control processes

Team Leadership & Development

• Build and lead a high-performing quality assurance team from inception
• Recruit, train, and develop quality professionals with expertise in biotechnology manufacturing
• Foster a culture of quality excellence and continuous improvement
• Provide technical guidance and mentorship to quality team members

Cross-functional Collaboration

• Partner closely with Manufacturing, Research & Development, and Regulatory Affairs teams
• Support technology transfer activities and process validation initiatives
• Collaborate with Supply Chain to ensure supplier qualification and vendor oversight
• Work with senior leadership to align quality objectives with business goals

Chief Operating Officer

Education

• Advanced degree (Master's or PhD) in Biotechnology, Biochemistry, Microbiology, Chemistry, or related scientific field
• Additional qualifications in Quality Management or Regulatory Affairs preferred

Experience

• Minimum 10-12 years of progressive experience in biopharmaceutical quality assurance
• At least 5 years in senior leadership roles within biotechnology or pharmaceutical manufacturing
• Extensive experience with monoclonal antibody or recombinant protein manufacturing quality systems
• Proven track record of successful regulatory inspections and submissions
• Experience establishing quality systems for new manufacturing facilities preferred

Technical Expertise

• Deep understanding of GMP requirements for biotechnology products
• Expertise in analytical method development and validation for biological products
• Knowledge of ICH guidelines, particularly Q8-Q12 (pharmaceutical development and quality)
• Familiarity with African regulatory frameworks and requirements
• Proficiency in quality management software systems and documentation platforms

Leadership & Communication Skills

• Demonstrated ability to build and lead cross-functional teams
• Excellent written and verbal communication skills in English
• Strong presentation and training capabilities
• Experience working in multicultural and international environments
• Ability to influence and collaborate effectively across all organizational levels

Preferred Qualifications

• Previous experience working in African healthcare or pharmaceutical markets
• Knowledge of French or Kinyarwanda languages a plus
• Professional certifications in Quality Assurance (ASQ, ISPE, or similar) a plus
• Track record of successful greenfield facility establishment

Personal Attributes

• Strategic thinker with strong attention to detail
• Results-oriented with commitment to excellence
• Adaptable and resilient in startup environment
• Passionate about advancing African healthcare capabilities
• Strong ethical foundation and integrity
• Cultural sensitivity and collaborative mindset