QA Outsource Lead
BiovacWes-Kaap, South Africa30+ days ago
Job descriptionAt least 3‑5 years’ experience in the vaccine / biotech or pharmaceutical manufacturing industry, of which at least 1 year is in sterile manufacturing At least 2‑3 years’ experience at a supervisory / management level in GMP pharmaceutical manufacturing or equivalent Experience in quality and regulatory compliance within a cGMP facility Strong knowledge of vendor management and GMP outsourced activities Experience having faced successful local and international quality audits Experience working with external customers / Applicants Provide strategic direction for QA Outsource operations together with the Release and Outsource manager, ensuring proactive interpretation and integration of evolving global regulatory and quality standards into organizational practices and vendor oversight frameworks. Lead Outsource section in the Release and Outsource departmental operational planning and execution, embedding quality‑by‑design principles and aligning delivery with long‑term business and regulatory objectives. Serve as the principal technical authority and QA advisor for all outsourced activities, ensuring strategic alignment, compliance, and continuous improvement across the vendor landscape. Direct the full lifecycle of outsourced quality activities, including vendor selection, approval, certification, change management, and ongoing performance monitoring ensuring cross‑functional alignment and risk‑based decision‑making. Drive organizational readiness for internal and external inspections, including global regulatory audits, through strategic planning, audit coordination, SME engagement, and real‑time oversight of CAPA closure and systemic improvements. Lead significant investigations, risk assessments, and deviation management within the outsourced space, presenting complex findings and remediation strategies to external stakeholders, including CMOs and applicants. Oversee the governance of the Vendor Management module in TrackWise, spearheading digital optimization and continuous improvement initiatives in collaboration with system and quality stakeholders. Ensure timely and strategic communication of vendor‑driven changes, including change notifications, artwork modifications, and quality complaints, through cross‑functional coordination and regulatory alignment. Define and execute the Outsource Quality data strategy, including the development, analysis, and reporting of key operational and compliance metrics (weekly, monthly, quarterly) to inform executive decision‑making to the Release and Outsource Manager. Author and approve critical quality documentation, including SOPs, WIs, vendor quality agreements, agent contracts, and vendor certification assessments—ensuring clarity, regulatory compliance, and traceability. Lead and govern internal and external audit programs, from planning and team formation to peer review, reporting, and enforcement of CAPA closure, ensuring that all vendor and supplier relationships remain audit‑ready and compliant. Champion a risk‑based approach to vendor management, conducting technical vendor risk assessments and utilizing data‑driven tools to prioritize and manage supplier relationships in alignment with corporate risk tolerance. Serve as the QA strategic lead on new product introductions, ensuring all materials and consumables meet quality expectations via structured onboarding through the vendor management system. Represent Biovac’s outsource QA function to global partners, ensuring transparent and effective communication during investigations, audit responses, and regulatory engagements. Escalate any significant / critical observations to the QARO manager and Head of Quality. Shape and align the department’s strategic focus and priorities with broader organizational goals, ensuring long‑term business value. Lead cross‑functional and enterprise‑level workforce planning, driving alignment between departmental capability and business growth strategies. Oversee advanced capacity planning and performance management to ensure optimal delivery across strategic, tactical, and operational horizons. Design and continuously refine role profiles, ensuring they support evolving business needs and align with future organizational structure. Drive a robust talent management agenda, including leadership pipeline development, succession planning, and high‑potential staff retention strategies. Foster a high‑performance culture through structured coaching, mentoring, and career development pathways, ensuring both technical and leadership capability within the department. Champion a resilient knowledge management framework, ensuring organizational intellectual capital is captured, protected, and leveraged. Establish robust continuity and delegation frameworks to safeguard business continuity in the absence of key personnel. Lead proactive employee relations management, ensuring alignment with labour legislation, internal policy, and business ethics while addressing performance and conduct risks decisively and constructively. 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 impact the business’s short‑, medium‑ and long‑term objectives. Participate with the site management team in proactively mitigating risks and finding solutions where possible. Serve as a core member of the site leadership team, providing expert input on risk anticipation, mitigation strategies, and cross‑functional solutioning to support business continuity and resilience. Own the strategic planning, budgeting, and resource governance for the section in the Release and Outsource department, ensuring alignment with broader organizational priorities, cost efficiency, and operational sustainability across shared site resources. Build own, team and site’s GMP Knowledge and Compliance. Participate in building quality objectives and provide ongoing metrics that directly support the achievement of such objectives. Participate in building a sustainable Quality Culture on site and proactively mitigate risks that may negatively impact quality or escalations may be appropriately managed. Establish and maintain a state of control related to quality management within the department. Ensure that the department is audit ready through closing out audit findings timeously. Ensure Deviations, Change Controls, CAPAs are handled effectively. Advocate continuous improvement within own department as well as cross functional.
QA Outsource Lead – Biovac
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 Outsource Lead to join a goal-oriented team.
Qualifications Needed
- Degree or Diploma in Biotechnology, Pharmacy, Biological Sciences, or a similar field
Necessary Experience & Industry Knowledge
Key Duties & Responsibilities
People Management
Business Management
Quality Management
Application Deadline : 07 November 2025
If you do not receive a response from us within three weeks of submitting your application, please understand that your application was not successful.
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.
Disclaimer : Dear Applicant, we appreciate your interest in joining our organization. It is imperative for us that you understand how we handle your information. We are committed to ensuring the security and confidentiality of the information you provide. Your personal details will be collected for the sole purpose of the application process and will be used strictly for that purpose. By applying, you acknowledge and consent to the collection, use, and protection of your personal information in accordance with our privacy policy. If you have any inquiries or concerns, our Human Capital department is available to provide clarification. We look forward to reviewing your application.
#J-18808-Ljbffr
Create a job alert for this search
Qa Lead • Wes-Kaap, South Africa
Related jobs
%20Ltd)
Our client is looking to hire a Senior Software QA Engineer to join their team.Maintain the high quality of the company's software.
Define, monitor and improve upon the Quality Assurance process and...Show moreLast updated: 30+ days ago 
)
- Promoted
Technical Project Lead
Ontec South AfricaWes-Kaap, South Africa Western Cape, South Africa | Posted on 21 / 05 / 2025.Ontec has a diverse team made up of innovative and competent individuals.
The company not only drives performance for employees to excel on a profes...Show moreLast updated: 30+ days ago
- Promoted
Quality Assurance Manager
EXLWes-Kaap, South Africa EXL City of Cape Town, Western Cape, South Africa.Are you ready to lead with purpose and drive performance?.We’re looking for a Quality Manager to elevate service delivery, drive innovation, and sh...Show moreLast updated: 1 day ago
- Promoted
Senior SDET
CollinsonWes-Kaap, South Africa Collinson City of Cape Town, Western Cape, South Africa.Join or sign in to find your next job.Collinson City of Cape Town, Western Cape, South Africa.
Direct message the job poster from Collinson.Ta...Show moreLast updated: 9 days ago
- Promoted
QA Analyst
Spinnaker SoftwareWes-Kaap, South Africa We’re looking for a QA Analyst to join our Technical Team.As the QA Analyst your role will involve reducing the number of bugs that go to field and assuring quality.
You should apply for this role i...Show moreLast updated: 30+ days ago
- Promoted
Enterprise Project Lead
Motivity ICTWes-Kaap, South Africa Job Title : Project Manager - Mobile Solutions.A mid-career level position that project manages the successful transition of mobile solutions for Business customers across a wide range of services a...Show moreLast updated: 30+ days ago
- Promoted
Project Lead Western Cape
Motivity ICTWes-Kaap, South Africa A mid-career level position that project manages the successful transition of mobile solutions for Business customers across a wide range of services and solutions including mobility and IoT.The ro...Show moreLast updated: 30+ days ago
- Promoted
Senior Software QA Engineer R85 000.00 per month
Hustle Consulting (Pty) LtdWes-Kaap, South Africa Our client is looking to hire a Senior Software QA Engineer to join their team.Maintain the high quality of the company's software.
Define, monitor and improve upon the Quality Assurance process and...Show moreLast updated: 30+ days ago
- Promoted
Head of Engineering & Operations
Network RecruitmentEden, South Africa Tertiary qualification is essential.Strong knowledge of production operations, quality systems, and project delivery.A collaborative, forward-thinking leader excited to take on the challenge of.Afr...Show moreLast updated: 30+ days ago
- Promoted
EMEA Team Lead, Customer Experience
MoonPayWes-Kaap, South Africa MoonPay City of Cape Town, Western Cape, South Africa.MoonPay City of Cape Town, Western Cape, South Africa.Be among the first 25 applicants.
We’re here to onboard the world to Web3.Because we think...Show moreLast updated: 30+ days ago
- Promoted
Lead Generator
WENZWes-Kaap, South Africa Researcher – Corporate Meeting Development.Basic Salary : R12,000 – R20,000 per month (based on experience).Computer & Internet Allowance : R1,000 per month.
Bonus : 2% on paid-up deals (meetings perso...Show moreLast updated: 1 day ago
- Promoted
Senior Software Qa Engineer Remote
Hustle Consulting (Pty) LtdWes-Kaap, South AfricaRemote
- Promoted
Lead Data Architect
Open Box SoftwareWes-Kaap, South Africa At Open Box Software, we don’t just deliver software - we help businesses unlock the power of data to drive smarter decisions.
If you enjoy translating complex requirements into powerful architectur...Show moreLast updated: 30+ days ago
- Promoted
QA Analyst
Open Box SoftwareWes-Kaap, South Africa Open Box Software is an internationally focused consulting company that specialises in business and software consulting services.
We have a young team of highly talented individuals who are driven t...Show moreLast updated: 30+ days ago
- Promoted
Engineering Lead OneX
TFG (The Foschini Group)Wes-Kaap, South Africa Talent Acquisition at The Foschini Group.Team Leadership - Manage resources through providing guidance, mentorship, and support to aid team members in meeting project and operational commitments.Ga...Show moreLast updated: 11 days ago
- Promoted
Controls Engineer
Network RecruitmentEden, South Africa Maintain and update the companys PLC standards, libraries, and technical documentation.PLC programming and industrial controls.
Strong hands-on experience with.Schneider PLCs, HMIs, and programming ...Show moreLast updated: 30+ days ago
- Promoted
Quality Specialist - S37C Death Claims
Old MutualWes-Kaap, South Africa Let's Write Africa's Story Together!.Old Mutual is a firm believer in the African opportunity and our diverse talent reflects this.
As a Quality Specialist, you will : .Provide a positive service expe...Show moreLast updated: 1 day ago
- Promoted
Senior Quality Assurance Engineer
ResourgenixWes-Kaap, South Africa Senior Quality Assurance Engineer.Resourgenix City of Cape Town, Western Cape, South Africa.Collaborate with developers and DevOps teams.
Drive QA practices within Agile / Scrum ceremonies.Possess 5+ ...Show moreLast updated: 30+ days ago
- Promoted
Technical Sales Advisor
Network RecruitmentEden, South Africa Relevant agricultural Degree (MSc Agric / BSc Agric / BAgric).At least 2-4 years experience in a similar position.Efficient in the use of Microsoft Office.
Good communication and negotiation skills.Visi...Show moreLast updated: 30+ days ago