Sr. Manager Quality Assurance
Job Description
The Senior Manager – QMS will lead the development, implementation, maintenance, and continuous improvement of the company’s ISO 13485-compliant Quality Management System across multiple manufacturing and support units. This role is critical to ensure consistent product quality, process efficiency, global regulatory compliance readiness, and a strong quality culture across the organization.
Key Responsibilities:
QMS Governance & Compliance
Lead the organization-wide implementation and maintenance of ISO 13485:2016 , 21 CFR Part 820 , Schedule V – MDR 2017 , and MDSAP -aligned QMS.
Ensure all quality-related processes, documents, and records are compliant and audit-ready at all times.
Conduct and manage internal quality audits , gap assessments, and follow-up on CAPA execution.
Coordinate and prepare for external audits by regulatory bodies, notified bodies, and customers.
Process Management & Documentation
Oversee the lifecycle of SOPs, Work Instructions, Quality Manuals, Validation Protocols , and other controlled documents.
Own and manage change control processes , deviation handling , document control , and quality records archiving .
QMS Performance Monitoring & Reporting
Develop and monitor quality KPIs , trends, and risk indicators.
Lead Management Review Meetings , presenting QMS effectiveness and improvement actions to top leadership.
Implement data-driven improvements across production, packaging, R&D, warehousing, and logistics.
People Leadership & Training
Lead and mentor the QMS team with a focus on talent development and succession planning.
Drive quality culture through employee awareness programs , GMP training , and process audits .
Collaborate with HR and other functions to standardize onboarding and functional training in QMS processes.
Cross-Functional Collaboration
Liaise with departments like Production, R&D, Engineering, Supply Chain, and EHS to ensure cross-functional QMS alignment .
Support manufacturing scale-up, new product transfers, and plant expansions from a quality systems standpoint.
Key Skills & Competencies:
Deep working knowledge of ISO 13485 , 21 CFR Part 820 , cGMP , MDSAP , and MDR 2017
Strong command over CAPA management , change control , risk management , and document control systems
Proficiency in QMS software/ERP tools and CSV (Computer System Validation) principles
Excellent analytical, presentation, and communication skills
Proven ability to lead cross-functional teams , manage audits, and influence quality ownership across levels
Strategic thinking with operational execution capabilities
Qualifications:
Bachelor’s or Master’s degree in Pharmaceutical Sciences , Engineering , Biotechnology , or Life Sciences
Certified Internal Auditor (ISO 13485) preferred
MBA in Operations/Quality/Healthcare will be an advantage
