General Manager Quality Assurance (QA)
Job Purpose
To lead the Quality Assurance function by ensuring compliance with global regulatory standards, maintaining an effective QMS, driving continuous improvement, and ensuring product quality and patient safety.
Key Responsibilities
- Lead and maintain QMS compliance as per ISO 13485, FDA QSR, EU MDR, MDSAP, and GMP.
- Handle internal, supplier, customer, and regulatory audits/inspections.
- Manage CAPA, deviations, root cause investigations, and risk management activities.
- Oversee validation activities including IQ/OQ/PQ, process, cleaning, software, and equipment validation.
- Approve SOPs, quality documents, validation reports, and product release activities.
- Ensure supplier qualification, complaint handling, and nonconformance management.
- Monitor quality metrics such as rejection, NCR, yield, and rework trends.
- Lead QA team development, training, and performance management.
- Coordinate with cross-functional teams and Regulatory Affairs for compliance and audit readiness.
Technical Skills
- ISO 13485, FDA 21 CFR Part 820, EU MDR, MDSAP, QMS (TrackWise), IPQA, CAPA, Validation, Risk Management, Audit Handling, GMP.
- Leadership Skills
- Decision Making, Cross-functional Coordination, Regulatory Communication, Crisis Management, Team Leadership.
Qualification
Bachelors/master’s degree in pharmacy, Life Sciences, Biomedical Engineering, Biotechnology, or related
