QMS Manager

Job Profile Summary:

The QMS Manager is responsible for overseeing the QMS team, ensuring efficient execution of Quality Management System (QMS) processes and adherence to company policies. The role analyzes QMS performance data, presenting findings to management, and facilitates cross-functional collaboration to resolve quality issues and coordinates risk assessments. The role drives continuous improvement initiatives, fosters a culture of quality excellence, and ensures adherence to budgets and schedules. The role manages talent selection , performance, and career development within the team, maintaining operational efficiency and effe ctiveness.

Job Responsibilities:

• Oversees the overall functioning of the QMS team, ensuring efficient execution of quality processes and strict adherence to company policies and other necessary requirements.

• Analyzes QMS performance data to identify trends, systemic issues, and improvement opportunities, and lead cross-functional teams in developing and implementing effective solutions to enhance quality and compliance.

• Serves as a senior quality advisor and key point of contact for regulatory bodies, ensuring that QMS processes and practices are fully compliant, and effectively managing external audits, inspections, and follow-up actions.

• Collaborates closely with senior leadership and cross-functional teams to integrate QMS processes with business strategies, drive a culture of quality excellence, and ensure alignment between quality objectives and business goals.

• Leads and manages complex, high-impact problem-solving initiatives using advanced quality tools and methodologies such as Six Sigma or Lean, ensuring effective resolution of critical quality issues and sustainable improvements.

• Facilitates cross-functional collaboration to address and resolve critical quality issues, ensuring alignment between departments and effective implementation of solutions.

• Oversees the management and resolution of non-conformance reports (NCRs), ensuring systematic tracking, thorough investigation, effective resolution, and implementation of preventive measures.

• Coordinates risk assessments and risk management activities, identifying significant risks to product quality and QMS integrity, and developing and implementing robust mitigation strategies.

• Drives and leads continuous improvement initiatives within the QMS, proposing strategic enhancements to processes, tools, and systems, and fostering a culture of quality excellence and operational efficiency throughout the organization.

• Establishes and ensures adherence to budgets, schedules, work plans, and performance requirements to maintain operational efficiency and effectiveness for a function/region/business.

• Manages talent across the team, while driving employee selection , performance management, compensation management, career development, and ensuring effective operational management.

• Participates in training sessions to stay updated on quality standards and QMS procedures, actively engaging in learning opportunities to enhance understanding of industry regulations and best practices.

Minimum Required Qualifications:

Education:

• Bachelor's / Master's Degree in Mechanical Engineering , Industrial Engineering, Science or equivalent.

Experience:

• Minimum 5 years of experience with Bachelor's OR Minimum 3 years of experience with Master's in areas such as Quality Management Systems, Quality Audits or equivalent in highly regulated environments/industries such as MD, Pharma, Automotive.
  

Preferred Qualifications:

Experience:

• Minimum 5 years of experience in leading teams and delivering on organizational objectives .
  

Preferred Skills:

Technical / Functional Skills:

• Regulatory Requirements

• Quality Management Systems (QMS)

• Project Management

• KPI Monitoring and Reporting

• Data Analysis & Interpretation

• Process Improvements

• Technical Writing

• Budget Management

• Agile Methodology

• Training Content Development

• Risk Management

• Regulatory Compliance

• Business Acumen

• Change Management