Manager, Safety, Health and Environment Management at The Kenya BioVax Institute

Job Purpose:

The Manager, Safety, Health, and Environment Management shall provide leadership, accountability and responsibility for the overall coordination of all aspects of human and environmental safety during the handling of biological and non-biological products used in manufacturing by undertaking constant risk management processes following environmental hazard assessment and environmental exposure assessment. This includes matters biosafety & biosecurity; occupational safety, health and environmental management through the implementation of safe work practices that are in line with regulatory requirements,  in accordance with adapted, local and international, pre-set standards and requirements as stipulated in World Health Organization Good Manufacturing Practices (WHO GMP); Environmental Management and Co-ordination Act (Cap 387); and The Occupational Safety and Health Act, 2007, Kenya Accreditation Service Act, 2019.

Additionally, shall create linkages and coordinate knowledge transfer of Safety, Health, Environment, and Biosafety/Biosecurity standards/processes/procedures in accordance with national, regional and international requirements.

Requirements:

• At least ten (10) years’ experience in the relevant field, three (3) of which have been in a supervisory position in the public or private sector;
• Master’s degree in any of the following fields; Biomedical Sciences, Health sciences, Public Health, Medical laboratory sciences, Environmental Safety, Occupational Safety and Health or any relevant Health Sciences or its equivalent qualifications from a recognized institution;
• Bachelor’s degree in any of the following fields: Biomedical Sciences, Health sciences, Public Health, Medical laboratory sciences, Environmental Safety, Occupational Safety and Health or any relevant Health Sciences or equivalent qualifications from a recognized Institution;
• Demonstrated merit and ability in managerial, administrative, and professional competence in work performance and results;
• Leadership course lasting not less than four (4) weeks from a recognized institution;
• Membership to a relevant professional body;
• Must have demonstrated merit and ability as reflected in work performance and results; and
• Meet the requirements of Chapter Six (6) of the Constitution.

Job Specification

Key Competencies and skills 

• Budgeting and planning;
• Knowledge of relevant legislation and regulations;
• Strategic, 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.

Key Duties & Responsibilities

• Coordinate and manage all activities relating to safety, health, environment (SHE) and biosafety/biosecurity in the Institute;
• Provide comprehensive and accurate information on all SHE and biosafety/biosecurity interventions;
• Steer development and review of policies, strategies, standards, procedures, and guidelines on SHE and biosafety/biosecurity
• Liaison with regulatory agencies and other external stakeholders such as but not limited to NEMA, NACOSTI, DOSHs and ISO Standards to ensure that SHE, Biosafety/Biosecurity inspections, certification or accreditation are implemented as per statutory requirements;
• Coordinate biorisk assessment for research departments, projects in Integrated biosciences and various research work areas for hazards identification, control and management;
• Supervise implementation of all Institutional matters of Safety, Health, Environment (SHE) and Biosafety/Biosecurity in key areas such as Laboratories, biobanks etc. and general areas, for compliance with regulatory requirements;
• Oversee the design and implementation of SHE, Biosafety and Biosecurity internal and external audit schedules, and ensure implementation. The schedules shall include but are not limited to NEMA environment self-audit, OSHA audit, noise survey, fire audit, and city council fire inspection and clearance;
• Supervise safety, biosafety, and biosecurity drills and co-ordinate all safety equipment servicing;
• Spearhead the preparation of comprehensive and accurate Institute’s SHE and Biosafety/Biosecurity documents, reviewing for completeness and accuracy ensuring submissions meet strict deadlines for submission and approval to the head of the department for timely transmission to regulatory authorities;
• Spearhead the review, track and follow up the progress, the approval and execution of standards, documents, and regulatory matters and provide feedback to top management on Institute performance metrics relating to standards and regulations;
• Promote good governance, provide leadership and foster teamwork among employees and play a key role in managing and motivating staff;
• Foster a culture that promotes ethical practice within the division;
• Inculcate succession management, employee growth and development and mentorship for staff in the division to meet both Institution’s and personal development goals;
• Contribute to current innovation, technical and operational knowledge on matters affecting pharmaceutical industry through publications, editorials, among others;
• Develop Health, Safety and Environment Policy with assistance of the designated safety committee and an occupational health officer to guide safe working conditions to minimize the risks associated with potential workplace hazards;
• Oversee implementation of the waste management plan and to ensure compliance to EMCA Act 1999 regulations, in the transportation, handling and disposal of biomedical waste from laboratories and clinics;
• Ensure maintenance of safety reference libraries: and disseminations of information to all who may need such knowledge regarding potential biologically hazardous materials and their control for continuous improvement;
• Develop biosafety and biosecurity program to ensure safe custody of all the samples, seed cultures etc are stored according to regulations and conducive for execution of production and research work;
• Coordinate communication and implementation of accident, incident guidelines as per institute SHE, Biosafety and Biosecurity policy including recording, investigation, corrective and preventive actions in promotion of culture of safety and security of personnel;
• Conduct safety and biosafety/biosecurity drills and co-ordinate all safety equipment servicing and repairs such as boilers, incinerators and firefighting equipment etc.;
• Liaise with audit and report on third party contractor requirement to meet Corporate SHE, Biosafety and Biosecurity policy and procedures;
• Schedule and facilitate safety committee meetings at a minimum quarterly;
• Set corporate targets and goals for SHE, Biosafety and Biosecurity performance improvement;
• Liaise and coordinate with the Division of Security and ICT in all appropriate areas to ensure coordination and compliance to all security policies and procedures;
• Acquire new knowledge from international protocols and best practices on SHE and Biosafety/Biosecurity relating to the production of vaccines, biologicals and other biomedical products and adapt them into Institute’s protocols;
• Develop and update annual compliance reports and ensure submission to relevant authorities as required;
• Validate maintenance plans for the repository with appropriate auditable Quality Systems incorporated that comply with international regulatory standards;
• Oversee execution of feedback sessions to relevant functional areas on completion of SHE and biosafety/biosecurity assessments;
• Coordinate the drafting and monitor implementation of work plans, budgets and performance targets;
• Create horizontal harmonious integration in the Institute;
• Facilitate the development of dynamic knowledge management systems on safety, health and environment management for use now and in the future;
• Inculcate risk management strategies in the division;
• Generate standards and regulations-related strategic proposals and resource mobilization for the division;
• Provide regular, thorough and prompt communication to the General Manager and CEO on key technical, financial and administrative matters;
• Develop research proposals, review manuscripts and proposals for scientific soundness and adherence to institute regulations and source for funding to sustain SMRF and advice on possible solutions in Biobanking with relevant functional areas;
• Organize Safety, Health, Environment (SHE) and Biosafety/Biosecurity training, workshops and seminars for capacity building, sharing of research information and networking;
• Implement research activities in Safety, Health, Environment (SHE) and Biosafety/Biosecurity priority areas to improve compliance with relevant functional areas;
• Evaluate the workplace environment and develop safety-management policies that identify and define the safety responsibilities of all employees;
• Lead the drafting and review of the Institute’s Health, Safety and Environment Policy with assistance of the designated safety Committee and an occupational health officer to guide safe working conditions to minimize the risks associated with potential workplace hazards;
• Develop, review and oversee the implementation of the waste management plan and to ensure compliance to EMCA Act 1999 regulations, in the transportation, handling and disposal of biomedical waste from laboratories and clinics;
• Conduct bio-risk assessment for research departments, projects in Integrated biosciences and various research work areas for hazards identification, control, storage and management;
• Establish safety reference libraries: and promote dissemination of information to all who may need such knowledge regarding potential biologically hazardous materials and their control for continuous improvement;
• Communicate and supervise implementation of accident, incident guidelines as per institute SHE, Biosafety and Biosecurity policy including recording, investigation, corrective and preventive actions in promotion of culture of safety and security of personnel;
• Execute safety and biosafety/biosecurity drills and co-ordinate all safety equipment servicing and repairs such as boilers, incinerators and firefighting equipment etc;
• Contribute to the development and implementation of mid- and long-term plans and projections for future anticipated physical and software expansions including upgrading the Institute’s Biological Specimen Repository processes, in close collaboration with relevant functional areas;
• Perform statutory regulatory activities namely quality management audits, laboratory inspections and work process audits;
• Identify, initiate and maintain collaboration and partnership to build and strengthen Safety, Health, Environment (SHE) and Biosafety/Biosecurity activities involving compliance management;
• Evaluate compliance with Environmental, Health and Safety Laws and Biosafety and Biosecurity laws and regulations;
• Organise an appropriate level of awareness, knowledge, and preparedness across the organization which should include first aid and fire marshals;
• Carry out formal risk assessment for the evaluation and management of SHE, Biosafety, and Biosecurity hazards across the Institute’s activities and branches;
• Undertake the identification of key risk areas and priorities, production and maintenance of SHE, Biosafety and Biosecurity risk registers with various departments and functional units; and
• Record and investigate all accidents and incidents and support implementation of corrective and preventive actions based on the findings and maintain an incident register