Quality Assurance Manager

Placements24; Redmond (WA); On-site; USD 55,000 - 79,000; Full time

Job summary

Placements24 is seeking a results-oriented Quality Assurance Manager to lead the quality systems team in Welkom. This leadership role ensures pharmaceutical manufacturing and operations comply with GMP, SAHPRA, FDA, EMA, and internal policies, with focus on building a robust QMS and driving continuous improvement.

The successful candidate will oversee audits, deviations, CAPA, batch release, and change controls, while mentoring the QA team and strengthening a culture of quality across the

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, or related field.
• 7+ years in pharmaceutical QA with 2+ years in management.
• Extensive GMP knowledge and regulatory requirements.
• Experience managing audits, deviations, CAPAs, and batch release.

Responsibilities

• Oversee development and maintenance of the Quality Management System (QMS).
• Lead and mentor the QA team with performance management.
• Conduct internal audits and manage external regulatory audits.
• Manage deviation investigations, CAPA, changes, and batch release.
• Ensure compliance with SAHPRA, FDA, EMA and industry best practices.

Skills

Leadership

Audits

CAPA

Quality systems

Regulatory knowledge

Communication

Education

Bachelor's degree in Pharmacy, Chemistry, Biology, or related field

Job description

About the Role

Our client is seeking a results-oriented Quality Assurance Manager to lead their quality systems team in Welkom. This leadership position is critical in ensuring that all pharmaceutical manufacturing and operational activities comply with stringent regulatory standards and internal quality policies. You will be responsible for developing, implementing, and maintaining the company's Quality Management System (QMS), driving continuous improvement, and fostering a culture of quality throughout the organization. The ideal candidate has a proven track record in pharmaceutical quality assurance, strong leadership capabilities, and a deep understanding of GMP principles.

Key Responsibilities

• Oversee the development, implementation, and maintenance of the company's Quality Management System (QMS).
• Lead and mentor the Quality Assurance team, providing guidance and performance management.
• Conduct internal audits, manage external audits (regulatory and customer), and ensure timely closure of audit findings.
• Manage deviation investigations, CAPA processes, change controls, and batch release activities.
• Ensure compliance with relevant pharmaceutical regulations (e.g., SAHPRA, FDA, EMA) and industry best practices.
• Review and approve critical quality documents, including SOPs, batch records, and validation protocols.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum of 7 years of experience in Quality Assurance within the pharmaceutical industry, with at least 2 years in a managerial role.
• Extensive knowledge of GMP, quality systems, and regulatory requirements.
• Proven experience in managing audits, deviations, CAPAs, and batch release.
• Strong leadership, communication, and interpersonal skills.
• Demonstrated ability to drive quality initiatives and continuous improvement.

Benefits

• Competitive salary package with annual performance bonus.
• Comprehensive health insurance, including medical, dental, and vision.
• Professional development opportunities and support for relevant certifications.
• A stable and reputable organization committed to producing high-quality pharmaceuticals.
• Generous annual leave and a contribution to a retirement fund.