Overview
HEAD OF QUALITY ASSURANCE Jobs in Time, Rogaland, Norway at Bio Usawa
Title: HEAD OF QUALITY ASSURANCE
Company: Bio Usawa
Location: Time, Rogaland, Norway
Job Description
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
Job Responsibilities
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
The Position Will Have The Following Direct Reports To
Chief Operating Officer
Qualifications
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
