Risk Management à Afrique du Sud

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, confident, proactive and meticulous Outsource Lead to join a goal-oriented team.

• Degree or Diploma in Biotechnology, Pharmacy, Biological Sciences, or a similar field

• At least 3-5 years' experience in vaccine / biotech / or pharmaceutical manufacturing industry of which at least 1 year of sterile manufacturing experience required.
• At least 2-3 years' experience at supervisory / management level in GMP Pharmaceutical manufacturing or equivalent.
• Experience in quality and regulatory compliance within a cGMP facility.
• Strong knowledge of vendor management and GMP outsourced activities.
• Experience in having faced successful local and international quality audits.
• Experience working with external customers / Applicants.

• Provide strategic direction for QA Outsource operations together with the Release and Outsource manager, ensuring proactive interpretation and integration of evolving global regulatory and quality standards into organizational practices and vendor oversight frameworks.
• Lead Outsource the Release and Outsource departmental operational planning and execution, embedding quality-by-design principles and aligning delivery with long-term business and regulatory objectives.
• Serve as the principal technical authority and QA advisor for all outsourced activities, ensuring strategic alignment, compliance, and continuous improvement across the vendor landscape.
• Direct the full lifecycle of outsourced quality activities, including vendor selection, approval, certification, change management, and ongoing performance monitoring ensuring cross-functional alignment and risk-based decision-making.
• Drive organizational readiness for internal and external inspections, including global regulatory audits, through strategic planning, audit coordination, SME engagement, and real-time oversight of CAPA closure and systemic improvements.
• Lead significant investigations, risk assessments, and deviation management within the outsourced space, presenting complex findings and remediation strategies to external stakeholders, including CMOs and applicants.
• Oversee the governance of the Vendor Management module in TrackWise, spearheading digital optimization and continuous improvement initiatives in collaboration with system and quality stakeholders.
• Ensure timely and strategic communication of vendor-driven changes, including change notifications, artwork modifications, and quality complaints, through cross-functional coordination and regulatory alignment.
• Define and execute the Outsource Quality data strategy, including the development, analysis, and reporting of key operational and compliance metrics (weekly, monthly, quarterly) to inform executive decision-making to the Release and Outsource Manager.
• Author and approve critical quality documentation, including SOPs, WIs, vendor quality agreements, agent contracts, and vendor certification assessments ensuring clarity, regulatory compliance, and traceability.
• Lead and govern internal and external audit programs, from planning and team formation to peer review, reporting, and enforcement of CAPA closure, ensuring that all vendor and supplier relationships remain audit-ready and compliant.
• Championing a risk-based approach to vendor management, conducting technical vendor risk assessments and utilizing data-driven tools to prioritize and manage supplier relationships in alignment with corporate risk tolerance.
• Serve as the QA strategic lead on new product introductions, ensuring all materials and consumables meet quality expectations via structured onboarding through the vendor management system.
• Represent Biovac outsource QA function to global partners, ensuring transparent and effective communication during investigations, audit responses, and regulatory engagements.
• Escalate any significant / critical observations to the QARO manager and Head of Quality

• Shape and align the departments strategic focus and priorities with broader organizational goals, ensuring long-term business value.
• Lead cross-functional and enterprise-level workforce planning, driving alignment between departmental capability and business growth strategies.
• Oversee advanced capacity planning and performance management to ensure optimal delivery across strategic, tactical, and operational horizons.
• Design and continuously refine role profiles, ensuring they support evolving business needs and align with future organizational structure.
• Drive a robust talent management agenda, including leadership pipeline development, succession planning, and high-potential staff retention strategies.
• Foster a high-performance culture through structured coaching, mentoring, and career development pathways, ensuring both technical and leadership capability within the department.
• Champion a resilient knowledge management framework, ensuring organizational intellectual capital is captured, protected, and leveraged.
• Establish robust continuity and delegation frameworks to safeguard business continuity in the absence of key personnel.
• Lead proactive employee relations management, ensuring alignment with labour legislation, internal policy, and business ethics while addressing performance and conduct risks decisively and constructively.

• Shared accountability for achieving the sites tactical plans and mitigation of any risk to the site operation including workflow, ethics, quality, finances, regulatory compliance and other material company requirements.
• Identify and continuously present key opportunities and synergies that will improve and / or expand the operation within own and / or other departments.
• Lead or participate in departmental and / or site wide projects.
• Monitoring & reporting on key operations, critical numbers and key performance indicators that impact on the business short-, medium- and long-term objectives.
• Participate with the site management team in proactively mitigating risks and finding solutions where possible.
• Serve as a core member of the site leadership team, providing expert input on risk anticipation, mitigation strategies, and cross-functional solutioning to support business continuity and resilience.
• Own the strategic planning, budgeting, and resource governance for the section in the Release and Outsource department, ensuring alignment with broader organizational priorities, cost efficiency, and operational sustainability across shared site resources.

• Building own, team and sites GMP Knowledge and Compliance.
• Participate in building quality objectives and provide ongoing metrics that directly support the achievement of such objectives.
• Participate in building a sustainable Quality Culture on site and proactive mitigate risks that may negatively impact quality or elevate these appropriately.
• Establish and maintain a state of control related to quality management within the department.
• Ensuring that the department is audit ready through closing out audit findings timeously.
• Ensure Deviations, Change Controls, CAPAs are handled effectively.
• Advocate continuous improvement within own department as well as cross functionally

Application Deadline : 28 May 2025

If you do not receive a response from us within three weeks of submitting your application, please understand that your application was not successful.

We believe in the magic of diversity within teams and to achieve this, we do apply Employment Equity principles during our selection process where this is necessary to achieve such diversity.

Disclaimer :

Dear Applicant, we appreciate your interest in joining our organization. It is imperative for us that you understand how we handle your information. We are committed to ensuring the security and confidentiality of the information you provide. Your personal details will be collected for the sole purpose of the application process and will be used strictly for that purpose. By applying, you acknowledge and consent to the collection, use, and protection of your personal information in accordance with our privacy policy. If you have any inquiries or concerns, our Human Capital department is available to provide clarification. We look forward to reviewing your application.