Quality Assurance Manager

1 week ago


Johannesburg, Gauteng, South Africa ICON plc Full time

**Job Title:** Quality Assurance Manager

About ICON plc:

We are a global company that provides clinical research and development services to the pharmaceutical, biotechnology, and medical device industries. Our team of experts works closely with clients to design and implement clinical trials that deliver high-quality data and support regulatory approvals.

Salary: R900,000 - R1,200,000 per annum (estimated)

Job Description:

We are seeking an experienced Senior Auditor, Quality Assurance to join our team in Gauteng, Johannesburg. The successful candidate will be responsible for conducting audits and assessments of quality systems, managing quality issues, and leading quality issue investigations.

Responsibilities:

  1. Conduct audits and assessments of quality systems to ensure compliance with regulations and industry standards;
  2. Manage quality issues and lead quality issue investigations to identify root causes and implement corrective actions;
  3. Support operations in root cause analysis and CAPA plan preparation to ensure effective resolution of quality issues;
  4. Develop and implement quality management systems to ensure ongoing improvement and compliance;
  5. Collaborate with cross-functional teams to drive business development activities and Q&C initiatives;
  6. Communicate effectively with stakeholders, including senior management, audit teams, and external partners.

Requirements:

  • 6+ years' experience working in a clinical, regulatory, pharmacovigilance, or quality environment within CRO/pharmaceutical/healthcare industry;
  • Advanced knowledge of GCP (Good Clinical Practice) and internal auditing standards;
  • Excellent organizational skills, attention to detail, and ability to work independently;
  • An undergraduate degree in a relevant field from an accredited institution or sufficient previous experience in auditing;
  • Experience in investigator site, vendor, and process audits;
  • Critical thinking and problem-solving skills, with ability to analyze complex data and generate innovative solutions;
  • Effective communication and interpersonal skills, with ability to influence and collaborate with cross-functional teams;
  • Fluent English language skills, both written and verbal.


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