Overview

Lead: Outsource and Release Jobs in Cape Town, South Africa at Biovac

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 and Release Lead to join a goal-oriented team.

QUALIFICATIONS NEEDED:

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

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

  • 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.

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

Core Technical Delivery:

  • 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 section in 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 Track Wise, 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

People Management:

  • 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…

Title: Lead: Outsource and Release

Company: Biovac

Location: Cape Town, South Africa

Category:

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