Senior Quality Assurance Specialist

Responsibilities

• Collaborate cross-functionally with teams in Cape Town and Boulder to ensure alignment and quality outcomes
• Lead and support investigations (NC and CAPA), including root cause analysis and implementation of effective corrective actions
• Review and approve complex quality records and documentation (e.g. batch records, NC and CAPA reports, change controls, certificates of analysis)
• Support production quality activities across manufacturing, QC testing, and supply chain
• Perform and support internal, supplier, and external audits, including audit readiness activities
• Support customer complaint investigations and ensure appropriate resolution and follow-up
• Review calibration, validation, and qualification documentation for compliance (equipment, processes, methods, and systems)
• Analyse QMS metrics and contribute to management review processes
• Lead or contribute to continuous improvement initiatives arising from audits, CAPAs, and business needs
• Contribute to training management and document control processes as part of ongoing QMS improvement
• Success in This Role Will Be Measured By
• Strong cross-functional collaboration and stakeholder alignment
• Timely and effective closure of CAPAs and NCs
• Audit readiness and successful audit outcomes
• Measurable improvements in QMS performance metrics
• Reduction in recurring or systemic quality issues
• Ability to make independent, risk-based quality decisions in complex or non-routine situations, ensuring compliance with requirements
• Education and Experience
• Minimum 8 years' experience in a quality environment (ISO 13485 and/or cGMP)
• Degree in biochemistry, molecular biology, or a related discipline (MSc or higher preferred)
• Demonstrated experience with CAPA, NC management, root cause analysis, change control, and audits
• Experience supporting manufacturing, product development, or QC in a life sciences or related environment
• Key Skills and Attributes
• Strong written and verbal communication skills, with the ability to clearly convey complex quality topics
• Ability to work independently while managing multiple priorities across global stakeholders
• Structured, pragmatic problem-solving approach
• High attention to detail and strong organisational skills
• Ability to influence and collaborate effectively across functions
• Commitment to quality, continuous improvement, and professional growth
• Preferred experience
• Experience in ISO 13485 and/or cGMP-regulated environments
• Familiarity with manufacturing processes for genomics reagents or medical devices
• Experience preparing for and participating in internal and external audits
• Why Join Us
• You'll be joining a growing, science-driven organisation where quality is a critical enabler of innovation and scale. This role offers the opportunity to take ownership, influence how systems evolve, and contribute meaningfully to delivering high

Benefits

Additional Information

Position: Senior Quality Assurance Specialist Position Type: Full-Time Employee Department: Quality Assurance Location: Salt River, Cape Town, South Africa (onsite) Experience: Minimum 8 years' experience in a quality environment (ISO 13485 and/or cGMP) & Degree in biochemistry, molecular biology, or a related discipline (MSc or higher preferred) Watchmaker Genomics is an early-stage life science company based in Boulder, Colorado (USA) with a location in Cape Town, South Africa. Our team is passionate about innovation and values collaboration, creativity and scientific rigour. We believe the intersection of biology, engineering and computer science presents exciting opportunities for developing novel technologies that promote research and improve human health. Watchmaker Genomics specialises in the design, development and production of DNA- and RNA-modifying enzymes that enable high-growth applications in genomics, molecular diagnostics, and personalised medicine. Position Description: Watchmaker is inviting applications for the full-time position of Senior Quality Assurance (QA) Specialist to join our QA Team based In Cape Town, South Africa. Role purpose The Senior QA Specialist is responsible for ensuring the effectiveness, compliance, and continuous improvement of key Quality Management System (QMS) processes within our ISO 13485-compliant environment. This role focuses on owning and improving core quality system elements (including CAPA, nonconformance (NC), and change control), supporting production quality, and enabling consistent delivery of high-quality products across global operations. Scope and Level of Responsibility Act as QA lead on complex or cross-functional quality system activities Take ownership of key QMS processes and ensure their effectiveness and compliance Make independent decisions within established quality frameworks Identify systemic issues and drive sustainable process improvements Provide guidance and mentorship to less experienced team members Contribute to the ongoing development and global alignment of the QMS

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