Commercial Quality Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Customer/Commercial Quality Job Category: Professional All Job Posting Locations: Mumbai, India Job Description: DePuy Synthes is recruiting for a QMS & HSD Lead - India, located in Mumbai, India. The QMS & HSD Lead – India plays a critical leadership role in ensuring the effectiveness, compliance, and continuous improvement of the Quality Management System (QMS) and Health, Safety & Environment (HSD) programs across DePuy Synthes India operations. This role partners closely with regional and global Quality, Regulatory, and business leaders to safeguard product quality, employee safety, and regulatory compliance while enabling operational excellence. This is an exciting opportunity to make a meaningful impact by strengthening quality culture, driving   risk ‑ based   decision making, and supporting business growth in a highly regulated medical device environment.

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.

Education   Bachelor’s degree   required   in Engineering, Life Sciences, Quality, Environmental Health & Safety, or   a related   discipline.   Master’s degree or advanced qualification preferred.   Experience and Skills   Required:   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.   Preferred:   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