Remote Principal QA Specialist: Quality Systems & Audits

Placements24; United States; Remote; USD 120,000 - 190,000; Full time

Job summary

Placements24 is seeking a Principal Quality Assurance Specialist for a remote-first role in the pharmaceutical sector. You will develop, implement, and maintain the Quality Management System (QMS), lead audits, and advise on regulatory compliance across FDA, EMA, and SAHPRA. Occasional travel to Randburg, Gauteng may be required.

This senior position demands 10–12 years in QA/QC, strong CAPA, document control, and the ability to influence quality culture in a remote work setting.

Qualifications

• Bachelor's or master's degree in a scientific field with 10–12 years in QA/QC.
• Extensive knowledge of cGMP, GDP, and FDA/EMA/SAHPRA guidelines.
• Proven experience in internal/external audits and CAPA systems.
• Strong communication and remote leadership capabilities.

Responsibilities

• Develop, implement, and manage the QMS for pharmaceutical operations.
• Conduct internal audits and lead external audits of suppliers and partners.
• Review and approve key quality documents (SOPs, validation protocols, batch records).
• Investigate deviations, non-conformances, and customer complaints; drive CAPAs.
• Ensure compliance with cGMP, ICH guidelines, and applicable regulations.
• Provide guidance on QA principles to internal teams and regulators.

Skills

Quality Assurance

Auditing

CAPA management

Regulatory compliance

Documentation

Education

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

Tools

eQMS software

Job description

Placements24 is seeking a Principal Quality Assurance Specialist for a remote-first role in the pharmaceutical sector. You will develop, implement, and maintain the Quality Management System (QMS), lead audits, and advise on regulatory compliance across FDA, EMA, and SAHPRA. Occasional travel to Randburg, Gauteng may be required.

This senior position demands 10–12 years in QA/QC, strong CAPA, document control, and the ability to influence quality culture in a remote work setting.