Senior Quality Assurance Associate (Pharmaceutical)

Job summary

The role involves ensuring that products and services meet quality standards within the pharmaceutical industry. The Senior Associate will lead and support preparations for customer audits and regulatory inspections, promoting best practices in quality systems.

Qualifications

• Bachelor’s degree in engineering, life sciences, pharmacy, or a related field.
• 5–7+ years of experience in GxP-regulated industries, particularly in audits and inspections within pharmaceuticals or medical devices.
• Proven experience in preparing, hosting, and responding to customer and regulatory inspections.
• Strong understanding of PQS/QMS frameworks (ICH Q10/Q9, EU GMP, 21 CFR) and data integrity principles.
• Demonstrated skills in CAPA management and root cause analysis techniques.

Responsibilities

• Lead and host customer audits and regulatory inspections, managing logistics and evidence.
• Coordinate audit readiness activities, including mock inspections and stakeholder coaching.
• Prepare and track CAPA plans, ensuring effectiveness verification and trend reduction.
• Interact with regulatory agencies regarding inspections and post-inspection actions.
• Collaborate with various departments to enhance compliance processes.
• Support the maintenance and improvement of the PQS in alignment with relevant guidelines.
• Monitor regulatory intelligence and update procedures and training accordingly.
• Track and report on key metrics related to audits and CAPA effectiveness.

Skills

• Excellent communication and stakeholder management skills, especially under pressure.
• Detail-oriented with the ability to lead audit preparations and present at all organizational levels.

Education

• Bachelor’s degree in a relevant field is required.

Tools

• Experience with Veeva Vault, TrackWise, and familiarity with SAP/QM is preferred.