Commercial Quality Specialist

Biopharma Asia; Mumbai; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

Johnson & Johnson’s DePuy Synthes India operates in Mumbai to strengthen the quality management system and ensure regulatory compliance for medical devices. The role leads the India QMS, drives audit programs, and champions a culture of safety and continuous improvement.

The Commercial Quality Specialist – India collaborates with regional/global teams and leaders to guide risk-based decisions, enhance product quality, and support business growth in a highly regulated environment.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, Environmental Health & Safety, or related discipline.
• Master’s degree or advanced qualification preferred.
• 5–8 years of progressive experience in Quality Management Systems and/or Health, Safety & Environment within a regulated industry.
• Strong working knowledge of global/local quality and HSE regulations and standards (e.g., ISO 13485, ISO 14001, ISO 45001, Indian regulations).
• Demonstrated experience leading audits, inspections and regulatory interactions.

Responsibilities

• Lead and maintain the India QMS in alignment with global DePuy Synthes/Johnson & Johnson standards, applicable regulations, and internal policies.
• Oversee HSD programs to ensure compliance with local/regional requirements and safety culture.
• Serve as primary quality and HSD partner for India leadership, providing strategic guidance and risk assessments.
• Lead internal and external audits, inspections, and assessments with timely remediation of findings.
• Drive continuous improvement initiatives, including CAPA, management review, and quality metrics.
• Ensure effective change management, document control, and training programs across India operations.
• Collaborate with Regional and Global QARA to align India practices with enterprise strategies.

Skills

Quality management

Regulatory compliance

Audit leadership

Risk assessment

Cross-functional collaboration

English proficiency

Education

Bachelor’s degree in Engineering, Life Sciences, Quality, EHS, or related

Master’s degree or advanced qualification

Tools

ISO 13485/ISO 9001 standards

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 Commercial Quality Specialist - India, located in Mumbai, India.

The Commercial Quality Specialist – 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, drivingrisk‑baseddecision making, and supporting business growth in a highly regulated medical device environment.

Key Responsibilities

Lead andmaintainthe 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,providingstrategic guidance, risk assessments, and decision support.

Lead internal and external audits, inspections, and assessments; ensuretimelyand 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.

Qualifications

Education

Bachelor’s degreerequiredin Engineering, Life Sciences, Quality, Environmental Health & Safety, ora relateddiscipline.

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 leadcross‑functionalinitiatives 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 anddata‑drivenquality metrics.

Strongproblem‑solving, risk management, anddecision‑makingskills.

Excellent written and verbal communication skills.

Other:

Language: Fluency in Englishrequired;proficiencyin local languages preferred.

Travel: Limited domestic travel; limited international travel as needed.

Certifications: Lead Auditor, Quality, or HSE certifications (e.g., ISO Lead Auditor, NEBOSH) preferred.

For more information on how we support the whole health of our employees throughout their wellness,careerand life journey, please visit www.careers.jnj.com .

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Data Compilation, Detail-Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing

Preferred Skills:

Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Data Compilation, Detail-Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing