Quality Assurance Systems Lead

Sharon Nurock Recruitment; Pinetown; On-site; ZAR 300,000 - 400,000; Full time

Job summary

A leading recruitment agency is seeking a Quality Assurance (QA) Systems Lead for a pharmaceutical manufacturer in KwaZulu-Natal, Pinetown. The role involves leading a QA team, overseeing quality management systems, and ensuring compliance with regulatory standards like cGMP and ISO13485. Candidates should hold a relevant Bachelor's degree and have over 5 years of experience in QA, including 2 years in a leadership role. This position is crucial in shaping systems that enhance patient care and safety.

Qualifications

• 5+ years' experience in pharmaceutical QA with QMS, audits, and compliance exposure.
• 2+ years in a leadership/supervisory role.
• Proven audit experience (ISO9001 / ISO13485 / GMP).

Responsibilities

• Lead and mentor a QA team, fostering a quality-focused culture.
• Manage and improve QMS systems including SAP QM and document control.
• Oversee audits, change control, and risk assessments.

Skills

Leadership

Analytical skills

Problem-solving skills

Education

Bachelor's in Chemical Engineering, Chemistry, Biochemistry, Pharmaceutical Sciences

Tools

SAP QM

SAP DMS

SharePoint

Job description

We’re partnering with a leading pharmaceutical manufacturer to find a Quality Assurance (QA) Systems Lead, a role that’s critical to ensuring compliance with cGMP, ISO13485, and industry standards while driving a culture of continuous improvement.

What You’ll Do:

• Lead and mentor a QA team, fostering a quality-focused culture.
• Manage and improve QMS systems including SAP QM and document control (SAP DMS, SharePoint).
• Oversee audits, change control, and risk assessments.
• Report on quality metrics and drive continuous improvement initiatives.
• Stay ahead of regulatory changes and align internal practices.

What We’re Looking For:

• Bachelor’s in Chemical Engineering, Chemistry, Biochemistry, Pharmaceutical Sciences or similar.
• 5+ years’ experience in pharmaceutical QA with QMS, audits, and compliance exposure.
• 2+ years in a leadership/supervisory role.
• Proven audit experience (ISO9001 / ISO13485 / GMP).
• Experience with ISO13485:2016 is an advantage.
• Strong leadership, analytical, and problem-solving skills.

This is your chance to step into a pivotal role where quality truly meets purpose, shaping systems that directly impact patient care and safety.

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