Commercial Quality Specialist

Overview

Lead and maintain the India Quality Management System and Health, Safety & Environment programs for DePuy Synthes India operations, serving as the primary quality and HSD business partner for India leadership.

What you'll do

• Lead and maintain the India QMS in alignment with global DePuy Synthes and Johnson & Johnson Quality & Compliance standards, applicable regulations, and internal policies.
• Oversee HSD programs to ensure compliance with local, regional, and company requirements, promoting a strong culture of safety and environmental responsibility.
• Serve as the primary quality and HSD business partner for India leadership, providing strategic guidance, risk assessments, and decision support.
• Lead internal and external audits, inspections, and assessments; ensure timely and effective remediation of observations and findings.
• Drive continuous improvement initiatives, including CAPA, management review, and quality metrics to enhance system effectiveness and compliance performance.
• Ensure effective change management, document control, and training programs across India operations.
• Collaborate with Regional and Global QARA partners to align India practices with enterprise strategies and regulatory expectations.

What you'll need

• Bachelor's degree required in Engineering, Life Sciences, Quality, Environmental Health & Safety, or a related discipline.
• Minimum 5–8 years of progressive experience in Quality Management Systems and/or Health, Safety & Environment within a regulated industry (medical devices, pharmaceuticals, or healthcare preferred).
• Strong working knowledge of global and local quality and HSD regulations and standards (e.g., ISO 13485, ISO 14001, ISO 45001, and applicable Indian regulations).
• Demonstrated experience leading audits, inspections, and regulatory interactions.
• Proven ability to lead cross-functional initiatives and influence stakeholders at multiple organizational levels.
• Fluency in English required.

Nice to have

• Master's degree or advanced qualification.
• Prior experience supporting manufacturing, distribution, or commercial operations in India.
• Experience working in a global or matrixed organization.
• Demonstrated success driving culture change and continuous improvement.
• Familiarity with digital quality systems and data-driven quality metrics.
• Strong problem-solving, risk management, and decision-making skills.
• Excellent written and verbal communication skills.
• Proficiency in local languages.
• Lead Auditor, Quality, or HSE certifications (e.g., ISO Lead Auditor, NEBOSH).

Details

• Location: Mumbai, India.
• Work mode: Hybrid.
• Travel: Limited domestic travel; limited international travel as needed.