Sr. Manager Quality Assurance

0 years

0 Lacs

Posted:1 month ago| Platform: Foundit logo

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Work Mode

On-site

Job Type

Full Time

Job Description

Senior Manager QMS

Key Responsibilities:

QMS Governance & Compliance

ISO 13485:2016

Ensure all quality-related processes, documents, and records are compliant and audit-ready at all times.

internal quality audits

external audits

Process Management & Documentation

SOPs, Work Instructions, Quality Manuals, Validation Protocols

change control processes

QMS Performance Monitoring & Reporting

quality KPIs

Management Review Meetings

data-driven improvements

People Leadership & Training

Lead and mentor the QMS team with a focus on talent development and succession planning.

employee awareness programs

onboarding and functional training

Cross-Functional Collaboration

cross-functional QMS alignment

Support manufacturing scale-up, new product transfers, and plant expansions from a quality systems standpoint.

Key Skills & Competencies:

ISO 13485

CAPA management

QMS software/ERP tools

Excellent analytical, presentation, and communication skills

lead cross-functional teams

Strategic thinking with operational execution capabilities

Qualifications:

Pharmaceutical Sciences

Certified Internal Auditor (ISO 13485)

MBA in Operations/Quality/Healthcare

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