QC Manager: Biochemistry

Job purpose

• To lead and manage Biochemistry activities in the Quality control operations supporting vaccine manufacturing.
• This role ensures that all testing activities—including QC release, engineering, process validation, stability, method development, validation, verification, and staff training—are conducted in compliance with cGMP, regulatory requirements and internal quality standards to support the release of sterile vaccine products.
• Accountable to lead, mentor and develop QC testing teams
• Ensure training, competency assessments, performance management, and succession planning.
• Oversee team workload planning, prioritization and resource allocation.
• Drive operational efficiency, assay robustness and laboratory capability enhancement.
• Manage day-day biological testing across multiple vaccine platforms.
• Ensure compliance with GMP, GLP, biosafety and aseptic laboratory operations.
• Oversee scheduling, sample management and turnaround time for testing.
• Ensure laboratory equipment is qualified, calibrated, verified and maintained.
• Maintain full regulatory compliance with WHO, SAHPRA and PIC/s requirements.
• Ensure adherence to data integrity standards (ALCOA+)
• Manage QC deviations, OOS/OOT results, CAPAs and change controls.
• Prepare for and actively participate regulatory inspections and internal/external audits.
• Provide subject matter expertise across biological assay platforms.
• Review and approve test protocols, results, reports and technical documents.
• Troubleshoot complex assay or laboratory performance issues.
• Ensure method lifecycle management (development, transfer, validation, routine use, retirement).
• Accountable for coordinating, reviewing and approving analytical method transfers in partnership with Senior QC technical lead,
• Provides technical and scientific leadership for biochemistry assay platforms, ensuring robust execution, continuous improvement, and lifecycle management of analytical methods supporting product release, stability, validation and investigations.
• Responsible for biochemistry support to the introduction of new raw materials and excipients, including review of material specifications, analytical testing requirements, risk assessments, method readiness, and support to qualification and change control activities.
• Lead QC readiness and execution for new vaccine introductions
• Manage and approve analytical method validations, verifications, transfers and qualification as per relevant guidelines.
• Contribute QC input into Validation Master plans, technical assessments, risk assessments and project milestones.
• Ensure QC support for process validation, cleaning validation, and equipment qualification.
• Support regulatory submissions through preparation and review of QC validation summaries and data packages.
• Lead initiatives in digitalization and automation for QC (e.g. LIMS and other electronic data systems)
• Implement scientific and process improvements aligned with GMP change control.
• Work closely with Manufacturing, Science & innovation, QA, Engineering, Regulatory affairs and supply chain.
• Provide QC representation in cross functional project teams and investigations.
• Support technology transfer, process scale-up, and lifecycle management activities.
• Responsible to ensure that the Quality control department and its respective sections deliver services and solutions in alignment with pharmaceutical quality system requirements.
• Ensure compliance in accordance with the Medicines and Related Substances Act 101 of 1965 and the Pharmacy Act 53 of 1974, and the organization’s policies, procedures and other applicable laws.
• Continuously build and support a sound quality assurance culture aligned to cGMP within Biovac.

Minimum qualification(s)

Required:

• Bachelor’s or master’s degree in microbiology, Biotechnology, Molecular Biology, Biochemistry, or related field. Preferred:

Postgraduate

Experience & industry knowledge

Required:

• At least 6 years’ experience in vaccine / pharmaceutical / biotech manufacturing industry.

• At least 3 years’ experience at junior to middle management level.

• Experience in quality and regulatory compliance within a cGMP facility.

• Business and operational planning.

• Program and project management

• Participation in developing a departmental budget and monitoring expenditures for multiple projects & funding sources. Preferred:

• Working with knowledge of Pharmaceutical Manufacturing related legislation

• Experience in aseptic (sterile) manufacturing and quality control

• Experience in having faced successfully local and/ or international quality audits.

• Experience in general business management within a commercial environment Key Duties and Responsibilities:

People Management

• Align departmental focus areas and outputs to the business’s objectives

• Conduct business, cross functional and departmental planning and execute activities within own scope of accountability.

• Adequate capacity planning and performance delivery in line with strategic, tactical and operational plans

• Role profiling, goal setting and performance management of managers and staff within the department.

• Develop and implement a knowledge management infrastructure within the department to ensure Intellectual Property is effectively maintained

• Growth, succession & retention of departmental talent.

• Accountability for own and team's personal and professional learning & development to ensure technical and leadership bench strength within the department

• Ensure accurate delegation of ongoing operational activities in the event of key staff members’ absence.

• Conduct effective employee relations in accordance with labour legislation, company policies and procedures and address any performance and conduct concerns and risks timeously. Technical Competencies required to perform this aspect of the role:

• KPI Development

• Resource & Capacity Planning & Management

• South African Labour Legislation

• Coaching & Mentoring of peers & staff Business Management

• Shared accountability for achieving the site’s 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 impacts the business’s short, medium and long term objectives.

• Participate with the site management team in proactively mitigating risks and find solutions where possible

• Effective and comprehensive costing, budgeting and expense management, taking all overlapping site activities into consideration. Technical Competencies required to perform this aspect of the role:

• Processes Development and Review

• Intermediate proficiency in Microsoft Word, Excel, Power point and Project.

• Metric & KPI development

• Technical Report Writing

• Operational Costing & Budgeting

• Statistical Literacy

• Coaching & Mentoring of peers & staff Core Technical Delivery

• Plan, Track and execute all QC activities related to your team to ensure successful completion within agreed timelines.

• Set overall objectives and measurements for direct reports that is aligned to the company overall goals.

• Drive continuous improvement plans and priorities through the implementation of appropriate tools or methodologies in order to proactively manage risk, reduce wastage and to improve quality on site.

• Reviews and Monitoring materials for reduced testing.

• Ensures that all monthly, quarterly and annual compliance reports are completed, reviewed and approved on time.

• Full co-ordination of all routine Biological testing ac