QA Outsource & Release Lead

Biovac; Cape Town; On-site; ZAR 900,000 - 1,300,000; Full time

Job summary

Biovac is seeking an Outsource and Release Lead to drive QA outsourced activities and vendor oversight in a GMP environment. You will lead planning, execution, and continuous improvement for outsourced quality processes, including audits and regulatory readiness, while coordinating with CMOs and external partners.

The role requires 3–5 years in vaccine/pharma manufacturing with supervisory experience, strong vendor management, and a track record of successful quality audits.

Qualifications

• Degree or Diploma in Biotechnology, Pharmacy, Biological Sciences, or a similar field.
• Experience in vaccine/biotech/pharma manufacturing and sterile manufacturing.
• 2–3 years in supervisory/management in GMP pharmaceutical manufacturing.
• Experience with quality and regulatory compliance within a cGMP facility.
• Experience handling vendor management and outsourced activities.
• Experience with local and international quality audits.
• Experience working with external customers/applicants.

Responsibilities

• Provide strategic direction for Outsource operations with Release and Outsource manager.
• Lead outsourcing in Release and Outsource planning and execution.
• Serve as QA authority for outsourced activities and ensure compliance.
• Oversee lifecycle of outsourced quality activities: vendor selection, certification, changes, monitoring.
• Coordinate inspections and audits, CAPA closure, and regulatory readiness.
• Lead vendor management governance and communicate changes to stakeholders.
• Define and execute data strategy with KPIs for executive decisions.
• Author critical quality docs: SOPs, WI, vendor contracts and certs.
• Govern and audit programs ensuring vendor relationships stay audit-ready.
• Champion risk-based vendor management and onboarding for new products.

Skills

QA Outsource

Vendor management

GMP

Audits

External customers

Education

Biotechnology/Pharmacy/Biology degree or diploma

Job description

Biovac is seeking an Outsource and Release Lead to drive QA outsourced activities and vendor oversight in a GMP environment. You will lead planning, execution, and continuous improvement for outsourced quality processes, including audits and regulatory readiness, while coordinating with CMOs and external partners.

The role requires 3–5 years in vaccine/pharma manufacturing with supervisory experience, strong vendor management, and a track record of successful quality audits.