Manager Quality Management

Zydus Group; Ahmedabad District; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

Zydus Group is seeking a QMS & Training Manager/Lead to steer the organization’s Quality Management System and Training Management Program, ensuring compliance with global regulatory standards. The role partners with cross-functional teams to maintain ISO 13485, FDA QSR/QMSR, EU MDR, and other international requirements, while driving process improvements, audit readiness, and training effectiveness.

Ideal candidate has 10+ years in regulated industries, experience with eQMS and LMS, and a

Qualifications

• Bachelor's degree in a related field is required.
• 10+ years of experience in Quality Assurance, QMS, or Compliance in a regulated industry.
• Experience with eQMS and LMS management and regulatory inspections.

Responsibilities

• Lead the development, implementation, and continuous improvement of the Quality Management System.
• Ensure compliance with ISO 13485, FDA QSR/QMSR, EU MDR, and other global regulations.
• Oversee document control, change control, and quality manuals/plans; manage audits/inspections.
• Lead Training Management, LMS governance, and role-based training matrices.
• Drive audit readiness and remediation activities; support regulatory inspections.
• Develop and monitor quality metrics and report to senior leadership.

Skills

ISO 13485

FDA QSR/QMSR

EU MDR

Audit readiness

LMS management

eQMS

Lean Six Sigma

Quality metrics

Cross-functional leadership

Regulatory compliance

Education

Bachelor's degree in B-Tech / Biomedical Engineering / Biotechnology / Quality Management

Master's degree in Engineering / Regulatory Affairs / Science

Certifications: CQA, CMQ/OE, Lean Six Sigma, etc.

Tools

eQMS software

LMS platforms

Job description

The QMS & Training Manager/Lead is responsible for leading and maintaining the organization's Quality Management System (QMS) and Training Management Program to ensure compliance with global regulatory and quality standards. The role oversees quality processes, document control, training governance, audit readiness, quality metrics, and continuous improvement initiatives.

The individual will act as the subject matter expert for QMS and training compliance, partnering with cross-functional teams to ensure adherence to regulatory requirements including ISO 13485, FDA 21 CFR Part 820, EU MDR, and applicable international standards.

Key Responsibilities:

Quality Management System Leadership

• Lead the development, implementation, maintenance, and continuous improvement of the Quality Management System.
• Ensure compliance with applicable regulations and standards, including:
• EN ISO 13485
• IMDR
• FDA 21 CFR Part 820 / QMSR
• EU MDR 2017/745
• Other applicable global regulations & Standards
• Establish and maintain QMS governance, procedures, and quality policies.
• Drive quality culture and operational excellence across the organization.

QMS Process Ownership

• Oversee key quality system processes including:
• Document Control
• Change Control
• Quality Manual / Quality Plans
• Internal and External Audits / Inspections
• Management Review
• Training Management
• Ensure processes remain compliant, efficient, and inspection-ready.

Training Program Management

• Own the corporate training compliance program.
• Develop and maintain role-based training matrices.
• Ensure regulatory, quality, and job-specific training requirements are assigned and completed on time.
• Manage Learning Management Systems (LMS) and electronic training records.
• Monitor training effectiveness and identify competency gaps.
• Collaborate with functional leaders to establish learning and development plans.

Audit & Inspection Readiness

• Lead internal audit programs and quality compliance assessments.
• Support and host external audits conducted by:
• Customers
• Drive audit observation remediation and effectiveness verification.
• Ensure inspection readiness across all QMS and training processes.

Metrics, Analytics & Reporting

• Develop and monitor QMS and Training KPIs.
• Prepare quality and compliance reports for management review.
• Analyze trends related to training effectiveness, audit findings, and quality compliance.
• Present quality system performance metrics to senior leadership.
• Identify opportunities for process simplification and automation.
• Lead quality improvement initiatives using Lean, Six Sigma, and risk-based approaches.
• Drive harmonization of quality processes across business functions and global sites.
• Promote best practices and compliance awareness throughout the organization.

Leadership & Stakeholder Management

• Provide leadership, coaching, and development to QMS and Training Processes.
• Partner with Regulatory Affairs, Engineering, Manufacturing, Operations, Clinical Affairs, and HR teams.
• Serve as a trusted advisor on quality system and training-related matters.
• Lead cross-functional quality projects and strategic initiatives.

Education & Qualifications

Required

• Bachelor's Degree in B-Tech , Biomedical Engineering, Biotechnology, Quality Management, or related field.

Preferred

• Master's Degree in Engineering, Regulatory Affairs, or Science
• Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), Lean Six Sigma Green Belt/Black Belt, or equivalent certifications.

Experience Required

• 10+ years of experience in Quality Assurance, QMS Management, or Compliance within a regulated industry.
• Strong working knowledge of ISO 13485, FDA QSR/QMSR, EU MDR requirements.
• Experience managing electronic QMS (eQMS) and Learning Management Systems (LMS).
• Proven success in supporting regulatory inspections and external audits.
• Quality Management Systems (QMS)
• ISO 13485 & Medical Device Regulations
• Document Control & Change Control
• Internal Auditing & Inspection Readiness
• Training Program Administration
• Learning Management Systems (LMS)
• eQMS Platforms
• Quality Metrics & Data AnalyticsStrategic Leadership
• Cross-functional Collaboration
• Stakeholder Management
• Problem Solving & Decision Making
• Program & Project Management

Career Level : Quality Management Systems & Training Manager

Ideal Candidate Profile: A seasoned quality professional with 10+ years of experience managing QMS and training programs in a regulated environment, capable of driving compliance excellence, leading audits and inspections, and building a strong quality culture across the organization.