General Manager, Regulatory Affairs, Quality and Safety at The Kenya BioVax Institute

Job Purpose:        

Ensure that the manufactured products are compliant with applicable regulatory and quality requirements, both national and international, and also to coordinate regulatory, safety, health, and environmental matters relating to the manufacturing activities.

Requirements:

• At least twelve (12) years of relevant work experience, four (4) years of which should have been in a senior management position in the public or private sector;
• Bachelor’s Degree in any of the following fields: Pharmacy, Life/Biological Sciences (Chemistry, Biochemistry, Biomedical Sciences, Microbiology), Analytical Chemistry, Health Sciences, Public Health/Environmental sciences, Medical laboratory sciences, Environmental Safety, Occupational Safety, and Health, or any other relevant or equivalent qualifications from a recognized Institution;
• Master’s degree in any of the following fields: Pharmacy, Life/Biological Sciences (Chemistry, Biochemistry, Biomedical Sciences, Microbiology) Health Sciences, Public Health/Environmental sciences, Medical laboratory sciences, Environmental Safety, Bio-risk management, Occupational Safety, and Health, or any other relevant or equivalent qualifications from a recognized Institution;
• Leadership Course lasting not less than four (4) weeks from a recognized institution;
• Demonstrated managerial, administrative, and professional competence in work performance and results;
• Membership to a relevant professional body where applicable;
• Proficiency in computer application; and
• Meet the requirements of Chapter Six (6) of the Constitution.

Key Competencies and skills

• Manufacturing and research science experience;
• Budgeting and planning;
• Knowledge of relevant legislation and regulations;
• Analytical and conceptual skills;
• Ability to form and maintain partnerships and collaborations;
• Excellent writing and communication skills;
• High emotional intelligence;
• Organizational skills including planning, monitoring and controlling;
• Managerial skills;
• Leadership skills;
• Interpersonal skills;
• Ability to work under pressure;
• Negotiation and influencing skills;
• Team building,
• Adaptability;
• Accountability;
• Decision making and problem-solving;
• Conflict management;
• Supervisory, coaching and mentoring skills;
• Integrity; and
• Results-driven.

Job Specification

Key Duties & Responsibilities

• Oversee the development, implementation, and review of policies, strategies, standards, procedures, and guidelines on production;
• Oversee the development and manufacture of vaccines, biologicals, and biomedical products that comply with local and international standards (such as World Health Organization, Pharmacy and Poisons Board, among others);
• Spearhead the process of designing, planning, and implementation of Product Development and production;
• Oversee planning, implementation, and management of biologicals and technologies development and production;
• Ensure adherence to international research protocols and best practice, training and mentoring of scientists as well as engineering;
• Oversee proper management and accountability of resources allocated to the technical programs;
• Liaise with relevant functional areas for optimal use and management of resources including human, financial, among others;
• Provide oversight and coordinate production activities in liaison with other relevant stakeholders;
• Facilitate timely preparation of Board papers on relevant technical matters;
• Provide advice to the Director General/CEO and senior management on all matters relating to production in the Institute;
• Review and coordinate the development of the Department’s strategic plans and objectives;
• Approve departmental performance appraisal systems and contracts;
• Oversee assets of the Department, and instituting operational accountability in liaison with Heads of relevant functional areas;
• Coordinate the implementation of production quality management systems;
• Ensure horizontal integration in the department;
• Promote good governance and leadership with integrity;
• Facilitate the development of dynamic knowledge management systems for immediate and future use;
• Spearhead the review and coordinate the implementation of work plans, budgets and performance targets;
• Facilitate the development of departmental long-term strategic plans programs;
• Coordinate the implementation of effective ICT systems in the department in liaison with relevant functional areas;
• Oversee Risk management in the department; and
• Liaise with relevant functional areas on production forecasting and sales.

Terms of Service

• The successful applicant will be appointed for five (5) year term and may be eligible for reappointment as per the Kenya BioVax Human Resource Policy and Procedures Manual.