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