Chief Manufacturing Officer

2 weeks ago

Cape Town, South Africa Biovac Full time

**BIOVAC** is one of the leading sterile vaccine manufacturers rooted in Africa, with our core purpose being to "protect life". We are looking to hire a dynamic, passionate & meticulous **_Chief Manufacturing Officer_** to join a goal-oriented team.

**QUALIFICATIONS NEEDED**:

- Post Graduate Technological, Chemical, Biological, Pharmaceutical, or similar qualification.
- Qualification in Business Commerce would be advantageous.
- Recognition is given to Prior Learning and practical experience.

**NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE**:

- At least 10 years industrial experience in a cGMP aligned biologics/pharmaceutical development and/ or commercial manufacturing entity.
- At least 5 years experience at top management level exposure with an in-depth understanding of the challenges involved in achieving commercial success whilst maintaining a compliant facility
- In-depth knowledge of local and international Codes and Guideline documents with respect to the Pharmaceutical Quality System (PQS) and experienced in its effective implementation as a risk-based tool resulting in continuous improvement throughout the site
- Strong understanding of cGMP
- Good global experience and networks and relationships with vaccine manufacturers and authorities relevant to regulations
- Experience in having successfully participated in local and international quality audits.
- Program and project sponsorship and management
- Understanding of Lean/Six sigma strategies.

**KEY DUTIES & RESPONSIBILITIES OF THE ROLE**:

- Ensure that the manufacturing site strategy is developed and aligned to the overall business strategy
- Closely monitor strategic and operations plan execution to ensure efficient, on time, and in full product manufacturing and delivery.
- Oversee ongoing risk mitigation related to manufacturing and supply chain operations, as well as ongoing refinement where required and agreed with Exco.
- Accountable for the planning and directing of all quality policies, programs, and initiatives to ensure that the PQS functions as a true risk-based, continuous improvement system, compliant to Regulatory requirements and yielding the required return on investment.
- Ensure that adequate specifications, targets, standards, margins, methods, and protocols are in place to minimise defects, optimise activities and ultimately contribute to increasing the companys profitability and sustainability.
- In collaboration with the RP, ensure that a compliant, robust Pharmaceutical Quality System is in place that operates effectively through PQS policies and procedures.
- Ensure a sustainable approach exists in terms of trending, root cause analysis, corrective and preventative action, risk grading and risk mitigation for all manufacturing-related process.
- Collaborate closely with key internal stakeholders across all business units to achieve effective functional synergies throughout the value chain.
- Develop data analytics capabilities that provide manufacturing insights which drives efficiencies and achieves delivery to the external market.
- Track appropriate & key performance indicators through key manufacturing site metrics and ensure all risks are adequately identified and accompanied with adequate mitigation plans.
- Lead and/ or participate in regular joint operations and quality meetings to review / address issues related to adherence to KPIs and SLAs, forecast demand versus achievement, issue escalations and solutions achievement, communication to all internal stakeholders and change management where required.
- Accountable for the leadership of IT, including selection and deployment of appropriate technology platforms that support company-wide activities.
- Ensure site manufacturing projects and investment decisions are timeously anticipated, adequately scoped, comprehensively documented and professionally presented to Exco for approval.
- Contribute to developing, reviewing, and approving regulatory submissions to ensure correct technical content.
- Oversee the preparation and utilisation of the manufacturing budget, providing short, medium
- and long-term forecasts and regular updates.
- Ensure that the Environmental, Health and Safety strategy is developed and aligned to the overall business strategy and that its implementation is closely monitored to ensure efficient delivery and risk mitigation, as well as ongoing refinement where required and agreed with Exco.
- Partner with the business development team to participate in due diligence activities in support of future product pipeline business opportunities.

**TECHNICAL COMPETENCIES REQUIRED TO SUCCEED IN THIS ROLE**:

- Sound working knowledge of contracting and service level agreements with partners and suppliers.
- Strategy & business plan development
- Zero based budgeting
- KPI & metrics development & measurement
- Business reporting and data trending
- Productivity & overall performance management
- Strong working knowledge of lean manufacturing methodolo

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