Sr. Manager Quality Assurance

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

Skills Required

Risk Management, Iso 13485, Cgmp, Change Control