Release & Outsource Manager

Biovac; Cape Town; On-site; ZAR 800,000 - 1,200,000; Full time

Job summary

A leading vaccine manufacturing company in South Africa is seeking a dynamic Release & Outsource Manager to join their team. This role involves overseeing the Release and Outsource department, ensuring compliance with quality standards, and managing vendor relationships. Candidates should have a degree in Pharmacy, with extensive experience in sterile manufacturing and management. The position calls for a proactive individual who can handle complex responsibilities in a fast-paced environment.

Qualifications

• At least 5-8 years' experience in vaccine/biotech/sterile manufacturing.
• Experience in quality and regulatory compliance within a cGMP facility.
• At least 3-5 years' experience at management level.

Responsibilities

• Manage all areas within the Release and Outsource department.
• Ensure appropriate manufacturing controls are in place.
• Evaluate and authorize any re-processing of products or materials.

Skills

Vaccine/biotech knowledge

Quality and regulatory compliance

Project management

Vendor management

Education

Degree or Diploma in Pharmacy

Job description

About the job Release & Outsource Manager

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 Release & Outsource Manager to join a goal-oriented team.

QUALIFICATIONS NEEDED:

• Degree or Diploma in Pharmacy.

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

• At least 5-8 years' experience in vaccine/biotech/sterile manufacturing.
• Industry, with 4 years' experience in release of sterile product.
• At least 3-5 years' experience at management level.
• Experience in quality and regulatory compliance within a cGMP facility.
• Experience in aseptic (sterile) manufacturing and Batch release.
• Business and operational planning.
• Program and project management.
• Participation in developing a departmental budget and monitoring expenditures for multiple projects & funding sources.

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

Core Technical Delivery Release Functions:

• Full accountability and responsibility for all areas within the Release and Outsource department consisting of Release, Outsource, Vendor Management and Projects.
• Overall management and implementation of specified QA processes and document systems including Product Quality Complaints, Product Quality Reviews, Adverse Events Following Immunization, Self-Inspections, National Regulatory Audits, Supplier Audits, Recalls, Artwork and Vendor Management.

Release

• Ensure that appropriate manufacturing controls, including master manufacturing and packing documents are in place.
• Responsible for approval of batch records.
• Ensure that the review all manufacturing and packing batch records is performed.
• Evaluate and authorize any re-processing of products or materials.
• Ensure that products are released in accordance with appropriate marketing authorization following full batch review and testing record review.
• Manage product quality complaints and participate in investigation of quality related complaints where needed.
• Respond to adverse drug reactions post immunization and participate in investigations with the pharmacovigilance officer.
• Provide a quality reports on adverse drug reactions post immunization to Pharmacovigilance Officer.
• Evaluate the stability data reports of all finished products, starting materials and intermediate products and, on the basis of stability data, participate with the team in making appropriate recommendations to ensure patient safety.
• Participate in investigations in the event of a medicines recall and compile relevant report.
• Participate in the review of the effectiveness of the medicines recall procedure together with the Responsible Pharmacist

Vendor Management & Outsourced Activities:

• Ensure that the vendor management program is in place and in compliance to cGMP.
• Ensure that an approved vendors list is maintained.
• Become a contact person for Biovac's Contract Manufacturing Organizations (CMO) for work coming in and going out.
• Liaise with the Responsible Pharmacist for all incoming products from CMOs
• Ensure continuous training of auditors within Biovac.
• Lead quality and for cause audits for vendors and Biovac's CMO to ensure timely audits, communication and resolution.
• Ensure that there are written contacts for all CMO's, and they are updated regularly when required.
• Ensure that all current master documents which includes but not limited to specifications, batch records are available and maintained as per SOP.
• Ensure that deviations from the CMO are communicated to site and appropriate departments are notified and the actions required and executed.
• Ensure that change notifications from the CMOs and suppliers are communicated to site and appropriate departments are notified and the actions required and executed.
• Design, plan, implement maintain, improving and actively participating in the development product exports within Biovac.
• Work with the Commercial department to ensure that exported product is in compliance to cGMP and SAHPRA
• guidelines.
• Ensure that all agents that Biovac exports product to have Quality contracts and adhere to cGMP of their country.
• Ensure compilation of Annual Product Reviews for all products processed on site during the preceding year.

Application Deadline: 03 May 2026

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.