Description
The successful incumbent will report to the Chief Operations Officer.
Summary of role
• Ensure that the Biovac project portfolio is successfully coordinated, executed delivered and documented in line with the organisations strategic and operational objectives.
Primary Responsibilities:
- Managing the Project Management Office and provide support to individual project managers.
- Custodian of the Project Management methodology and standards.
- Stakeholder relationship management between Biovac and manufacturing as well as tech transfer partners.
- Balance and manage inter-dependencies between projects.
- Negotiating with operational heads for required resources once a project has been approved.
- Ensuring resource allocation is driven by the relative project priorities.
- Provide strategic support to ensure inter-departmental synergies and behaviour within a comprehensive programme management governance framework.
- Implementing and managing changes and interventions to ensure project goals are achieved.
- Procure contingency resource(s) as and when required for large infrastructure or specific technical projects.
General
- Continually strive to deliver solutions through team work that ensures continuous improvement through innovative solutions.
- Active guidance, coaching and mentoring of departmental staff.
- Ensure compliance in accordance with the Medicines and Related Substances Act 101 of 1965 and the Pharmacy Act 53 of 1974, and the organization’s policies, procedures and other applicable laws.
- Continuously build and support a sound quality assurance culture aligned to cGMP within Biovac.
QUALIFICATIONS
Required
• University Graduate in appropriate technical area, Chemistry, Biochemistry, Engineering
• Internationally recognized Project management qualification such as PMI or Prince 2®
Preferred
• Post Graduate
• Recognition is given to Prior Learning and practical experience.
Other Requirements:
• After hours availability, reliable transport, ability to travel nationally and internationally
EXPERIENCE & INDUSTRY KNOWLEDGE
Required:
• At least 8 years’ experience in vaccine / biotech industry or equivalent.
• At least 5 years’ project management experience.
• At least 5 years’ experience at middle to senior management level.
• Previous programme or multiple project management experience.
• Experience in quality and regulatory compliance within a cGMP facility.
• Experience in business and operational planning.
• Knowledge and proven implementation of change management principles.
• Participation in developing a departmental budget and monitoring expenditures for multiple projects & funding sources.
Preferred:
• Experience in managing a Programme management office would be preferable including experience with the following aspects.
o Experience in develop project management strategy and framework
o Develop PM processes & procedures based on proven methodology
o Develop PM norms and standards in line with pharmaceutical industry
o Establish, implement PM tools and techniques (systems)
• Working knowledge of Pharmaceutical Manufacturing related legislation
• Experience in aseptic (sterile) manufacturing
• Experience in having faced successfully local and/ or international quality audits • Experience in general business management within a commercial environment
Competencies
- KPI Development
- Resource & Capacity Planning & Management
- South African Labour Legislation
- Coaching & Mentoring of peers & staff
- Processes Development and Review
- Intermediate proficiency in Microsoft Word
- Excel, Power point and Project.
- Metric & KPI development
- Technical Report Writing
- Operational Costing & Budgeting
- Statistical Literacy
- cGMP vaccine manufacturing- quality and regulatory compliance knowledge, i.e. MCC and
WHO
- Total Quality Management & Quality
- Management Systems
- Data development, trending & reporting
Generic
- Planning, Organising, Execution & Delegation
- Strategic & Holistic Thinking
- Creative Problem Solving & Innovation Skills
- Sustainable Stakeholder Management
- Financial Acumen
- Commercial Awareness
- Action & Results Oriented
- Assertive & Resilient
- Adaptable in Responding to change
- Negotiation and influencing skills
- Proactive in mitigating risk
- Clear, timely and effective communication skills both verbally and in writing
- Analytical Ability
- Maintain confidentiality and trust
- Ethical leadership