Quality Systems and Training Lead

**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 Quality Systems and Training Lead to join a goal-oriented team. **QUALIFICATIONS NEEDED**: - Bachelor's degree or diploma in Microbiology/ Biotechnology, Pharmacy, or equivalent. - Certification with Trackwise enterprise. **NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE**: - At least 5 years of experience in the vaccine/ biotech/ or pharmaceutical manufacturing industry of which at least 3 years of sterile manufacturing experience is required. - At least 2-3 years of experience at the supervisory/management level in GMP Pharmaceutical manufacturing or equivalent - Experience in quality and regulatory compliance within a cGMP facility - Strong knowledge of sterile manufacturing environments. - Experience in having faced successful local and international quality audits. - Technical understanding of the Salesforce platform, Salesforce Infrastructure, and eQMS systems - Working knowledge of Salesforce platform, Trackwise System, and system design including the use of process builders and flows - Experience in Training within an Aseptic Manufacturing facility. **KEY DUTIES & RESPONSIBILITIES OF THE ROLE**: - Manage and maintain the TrackWise system, including user access, security configurations, and system settings. - Customize workflows, forms, and templates to align with the organization's specific quality processes. - Regularly update and optimize the system to enhance its usability and efficiency. - Manage all Quality systems activities, planning to ensure that department goals are timeously obtained. - Overall responsible for all systems within the PQS (Pharmaceutical Quality systems) including Deviations, CAPAs, Change Controls, Quality Risk Management and, DocMS, Logbook management, Archiving, Trackwise Management. - Leads and participates in all QA engagement with external third-party stakeholders (e.g., Pfizer and Sanofi) where Quality systems are impacted. - Coordinate and analyze all site metrics appropriate with the PQS and drive continuous improvement. - Implements digital solutions to Quality processes as part of continuous improvement. - Manage activities in the Document Control Centre related to providing required documentation and implementing and maintaining related documentation systems (DocMS, Archiving, SharePoint templates, Logbook management). - Coordinate and analyze all site metrics appropriate with the PQS and drive continuous improvement. - Lead the site management review and ensure that action plans are tracked and implemented. - Leads and participates in all QA engagement with external third-party stakeholders (e.g., Pfizer and Sanofi) where Quality systems are impacted. - Responsible for ensuring that site compliance metrics are achieved, and actively participates in driving site compliance. - Leads all audit preparation activities on site. - Review and lead all discussions around site metrics with the applicants. - Provide technical guidance to QA Systems and the site team on the QMS processes. - Drive continuous improvement on site. - Responsible to keep up to date with cGMP and Guidelines. Ensure that this is updated within the site library. - Ensures that obligations, as set out in the Quality agreements, are fulfilled during the QMS process. - Review and approve documentation within defined timelines as stated in SOPs. - Review and approve all Deviations, Change controls, Incidents, and CAPAs linked to the Quality system. - Check the maintenance of the department, premises, and equipment to ensure optimal operation at all times. - Oversee customer and regulator audits and ensure tracking and closure of findings, whilst maintaining appropriate communication between Biovac and auditors. - Ensuring that the document control activities are achieved at the required quality levels (Biovac, SAHPRA, and WHO), within the agreed timeframe. - Ensure proper management of archived documents. - Supports the QA operations manager with key site projects. - Ensures that scientific rationales, risk assessments, and reports are in place to support operations. - Leads all QA digitalization projects. - Lead significant investigations that can impact Quality Systems. - Lead significant risk assessments in accordance with ICH Q9. - Responsible for ensuring that the eQMS (Trackwise digital) is effectively maintained, updated to the latest cGMP requirements, and operational to support site activities. - Leads all audit preparation activities within the QA departments on site. - Review and lead all discussions around site metrics with the applicants. - Responsible for ensuring that the eQMS (Trackwise digital) is effectively maintained, updated to the latest cGMP requirements, and operational to support site activities. - Responsible for the Site GMP training program. - Engages with internal