Head of Department Quality

6 months ago

Cape Town, South Africa Biovac Full time

**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 Head of Department: Quality to join a goal-oriented team.


**QUALIFICATIONS NEEDED**:

- Bachelor's degree or diploma in Microbiology/ Biotechnology, Pharmacy or equivalent.

**NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE**:

- At least 10 years of experience in the vaccine/ biotech/ sterile or pharmaceutical manufacturing industry.
- At least 5 years of experience at middle to senior management level in cGMP pharmaceutical manufacturing or equivalent.
- Experience in Quality, Quality control, Vendor management, Release, validation, and regulatory compliance within a cGMP facility.
- Strong knowledge of sterile manufacturing environments.
- Experience in having faced successful local and international quality audits.
- Business and operational planning.
- Participation in developing a departmental budget.
- Program and project management.
- Participation in developing a departmental budget and monitoring expenditures for multiple projects & funding sources.

**KEY DUTIES & RESPONSIBILITIES OF THE ROLE**:

- Full accountability and responsibility for all areas within the Quality Business unit consisting of Quality Assurance, Quality Control, Validation, Outsource and Quality Projects.
- Full accountability for Quality Control functions including Chemistry, Biological, and microbiological and the output thereof.
- Manages the release team and ensures that all business requirements are met for the department.
- Accountable for ensuring that the Quality management system is maintained and continuously improved to drive a Quality culture.
- Ensure that Sterility assurance complies with cGMP and is continuously improved on-site.
- Ensure that the Validation master plan (VMP) and Validation Plans (VPs) are in place and continuously updated in accordance with the latest regulatory guidance.
- Ensure that all equipment, utilities, and facilities are appropriately qualified, and that the Qualification section functions according to compliance and quality requirements.
- Overall management and implementation of specified QA processes and document systems including Deviations, CAPAs, Change Controls, and Quality Risk Management.
- Ensure that a vendor approval system is in place for goods and services and that supplier audits are conducted in accordance with the relevant SOP and schedule.
- Ensure that procedures and specifications are appropriate and followed including the procedures and specifications of contract manufacturers, contract laboratories, etc.
- Ensure that Quality and Technical agreements are in place and maintained where applicable for all outsourced/service providers.
- Ensure that products are released in accordance with appropriate marketing authorization following full batch and testing record review.
- Lead Quality Council meetings and PQS are regularly held, and that appropriate metrics are monitored, as assurance of suitability and effectiveness of the PQS.
- Ensure that site projects are overseen by Quality assurance and that QbD principles are applied to all new site projects and designs.
- Benchmark against quality standards of industry and regulatory bodies and create awareness of GMP updates, as appropriate throughout the site.
- Leads and facilitates all External Regulatory audits on site.
- Oversee third-party customers and new third-party partners audits.
- Ensures that all QA engagement/interactions with external third-party stakeholders are timeously held and escalations discussions with the Senior Management team.
- Ensure that an internal audit program is maintained on-site to continuously improve the Quality management system.
- Evaluate the stability data reports of all finished products, starting materials, and intermediate products and based on stability data, participate with the team in making appropriate recommendations to ensure patient safety.
- Approving and monitoring of contract laboratories, contract manufacturers, and suppliers.
- Ensure that site investigations are overseen by Quality Assurance.
- Define project deliverables in conjunction with HOD and project managers.
- Maintain and update the library of quality and industry knowledge resources (guidelines and standards).
- Participate in investigations in the event of a medicines recall and compile relevant reports.
- Participate in the review of the effectiveness of the medicines recall procedure together with the Responsible Pharmacist.
- Continuously improve systems and processes by assessing practices to international and regulatory standards.
- Manage internal stakeholders and customer relations through effective collaboration.
- Establish, and review metrics to ensure optimal functioning of departments.
- Develop a departmental budget and monitor expenditures for multiple projects & funding sources.

**App

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