Senior Specialist - R&D Quality

Mcneil Ab; India; Remote; INR 1,800,000 - 2,400,000; Full time

Job summary

Kenvue in India seeks a Senior Specialist, R&D Quality to provide strategic quality oversight across analytical, microbiology, stability, and product development. This role ensures compliance with QMS, GLP, GDP, data integrity, and regulatory expectations while partnering with cross-functional teams.

You will lead investigations, CAPAs, supplier quality programs, audit readiness, and validation activities, driving continuous improvement and a strong quality culture across the organization.

Responsibilities

• Stability Quality Oversight: Review stability protocols/reports/closeout to ensure compliance and lead transformation initiatives.
• Investigation, CAPA & Quality Risk Management: Lead investigations, deviations, risk assessments, CAPA closure.
• Analytical Quality & Product Development Support: Review method validation, test methods, protocols and reports; support TMV and study reports.
• Microbiology Laboratory Quality Oversight: Ensure compliant microbiology lab operations and continuous improvement.
• Laboratory Compliance & Operational Excellence: Monitor SOPs, data integrity, GLP, GDP; drive lab excellence.
• Supplier Quality Management: Lead supplier audits and quality agreements for materials and CDMOs.
• Audit & Inspection Readiness: Support internal/external/regulatory audits and CAPA implementation.
• Documentation & Records Management: Oversee controlled documents and records per GDP.
• Computer System Validation & Digital Quality: Support CV and lifecycle management of computerized systems.

Job description

Kenvue is currently recruiting for a:

Senior Specialist - R&D Quality

What we do

At Kenvue , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you! Join us in shaping our future-and yours. For more information , click here .

Role reports to: Manager, R&D Q&C

Location: Asia Pacific, India, Maharashtra, Greater Mumbai

Work Location: Fully Onsite

What you will do

Job Purpose

The Senior Specialist, R&D Quality provides strategic quality oversight and compliance leadership across R&D Analytical, Microbiology, Stability, and Product Development functions. The role is responsible for ensuring adherence to Quality Management System (QMS) requirements, global regulatory expectations, Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and data integrity principles. This position partners with cross-functional stakeholders to manage investigations, CAPAs, supplier quality programs, laboratory compliance, audit readiness, computerized system validation, and stability quality activities while driving continuous improvement and quality culture across the organization.

Key Responsibilities

• Stability Quality Oversight Provide quality oversight for stability programs supporting Self Care and Food product portfolios. Review Stability Protocols, Stability Reports, Stability Closeout Reports, and associated documentation to ensure compliance with internal procedures, regulatory requirements, and scientific standards. Lead and support stability transformation initiatives to improve processes, compliance, and operational efficiency.
• Investigation, CAPA & Quality Risk Management Lead end-to-end management of laboratory investigations, deviations, and quality events. Facilitate root cause analysis, risk assessments, effectiveness verification, and implementation of corrective and preventive actions. Ensure timely closure of investigations and CAPAs while maintaining compliance with quality and regulatory requirements.
• Analytical Quality & Product Development Support Provide quality review for Method Validation reports, Test Method reviews, Technical Justifications, analytical protocols, and study reports supporting Self Care and Food products. Ensure scientifically sound analytical practices and regulatory compliance throughout product development and lifecycle management activities. Support TMV, Development Protocols, Stability Protocols, Study Reports, and Sample Release activities.
• Microbiology Laboratory Quality Oversight Provide end-to-end quality oversight of microbiology laboratory operations, including compliance monitoring, investigations, documentation review, training support, and implementation of continuous improvement initiatives. Ensure laboratory activities remain inspection-ready and aligned with corporate quality standards.
• Laboratory Compliance & Operational Excellence Drive laboratory compliance through routine assessments, laboratory rounds, and Gemba Walks. Monitor adherence to SOPs, data integrity requirements, GLP, GDP, and quality procedures. Identify compliance risks, implement corrective actions, and promote operational excellence across laboratory functions
• Supplier Quality Management Lead Auditor for supplier qualification, monitoring, and audit programs for raw material suppliers, contract laboratories, and CDMOs. Conduct supplier audits, assess supplier performance, manage quality agreements, and ensure suppliers consistently meet quality, regulatory, and business requirements for Food, Self Care, and Essential Health products.
• Audit & Inspection Readiness Serve as a key quality representative during internal audits, external audits, and regulatory inspections. Support audit planning, observation management, CAPA implementation, and inspection readiness activities to ensure sustained compliance across R&D operations.
• Documentation & Records Management Provide oversight of document control and records management processes. Review, approve, and maintain SOPs, work instructions, forms, protocols, reports, and quality records. Ensure compliance with GDP requirements and effective lifecycle management of controlled documents and records.
• Computer System Validation & Digital Quality Support validation and lifecycle management of computerized labo