Senior Specialist - R&D Quality

Kenvue Inc.; Mumbai; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Kenvue Inc.はR&D品質のスペシャリストとして、分析・微生物・安定性・製品開発の品質管理を統括します。QMS遵守を推進し、CAPAと調査の完遂、供給業者の監査・品質契約の維持、データの信頼性確保などを担当します。検証済みの手順と規制要件を満たす体制を構築し、組織全体の品質文化を高めます。

この役割はGMP/GLPの専門知識を活かし、内部監査・外部監査の準備、Veeva Vaultなどの電子システム活用を含むデジタル品質の推進にも携わります。インド太平洋地域のJakarta以降の拠点と連携して、規制対応と継続的向上を推進します。

Qualifications

• 修士号または同等の理系学位が必須で、品質保証/研究開発品質における実務経験が求められる。
• QMS/調査/CAPA/サプライヤー品質/監査管理/データ整合性の専門知識が必要。
• GLP/GMP/GDPの理解と監査準備の経験が望ましい。

Responsibilities

• R&Dの分析、微生物学、安定性、製品開発の品質管理を統括する。
• 内部監査・外部監査・規制監査の準備と対応をリードする。
• サプライヤー監査・品質契約の管理と是正処置の実施を推進する。

Skills

QMS

Investigations

CAPA

Supplier Quality

Audit Management

Regulatory Compliance

Data Integrity

GMP/ GLP

Education

Master’s degree in pharmacy/chemistry/microbiology/biotechnology/life sciences

Tools

CSV

Veeva Vault

ELM

Electronic quality systems

Job description

Kenvueは現在、以下求人を募集しております。

Senior Specialist - R&D Quality

私たちがしていること

私たちKenvueは、日々のケアが持つ驚くべき力を信じています。100年以上の伝統と科学に根ざし、Neutrogena®, Aveeno®, Tylenol®, Listerine®, Johnson’s® and BAND-AID®など、皆様が既にご存じでご愛用いただいているアイコニックなブランドを提供しています。科学は私たちの情熱であり、ケアは私たちの才能です。

Who We Are

私たちのグローバルチームは、インサイトとイノベーションに情熱を注ぎ、最高の製品をお客様にお届けすることに全力を注ぐ、多様で優秀な22,000人以上の社員で構成されています。専門知識と共感力を備えたKenvuerであることは、毎日何百万人もの人々の生活に影響を与える力を持つことを意味します。私たちは、人を第一に考え、全身全霊をもってケアし、サイエンスで信頼を獲得し、勇気をもって解決します。私たちとあなた自身の未来を、共に切り開いていきましょう。

Role reports to:

Manager, R&D Q&C

場所:

Asia Pacific, India, Maharashtra, Greater Mumbai

勤務地:

フルオンサイト

あなたがすること

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 laboratory and quality systems. Review validation documentation, protocols, test scripts, and reports to ensure compliance with regulatory requirements. Support Veeva deployment, electronic learning management systems, and digital quality initiatives to enhance compliance and efficiency.

Regulatory Compliance Assessment

Monitor emerging regulations, industry guidelines, and quality requirements impacting R&D activities. Conduct regulatory impact assessments and support implementation of regulatory changes to ensure ongoing compliance and proactive risk management.

Qualifications

• Master’s degree in pharmacy, Chemistry, Microbiology, Biotechnology, Life Sciences, or related scientific discipline.
• Minimum 10 years of experience in Quality Assurance, R&D Quality, Laboratory Compliance, Analytical Sciences, or regulated laboratory environments.
• Strong expertise in QMS, Investigations, CAPA, Supplier Quality, Audit Management, Data Integrity, and Regulatory Compliance.
• Experience with Computer System Validation (CSV), Veeva Vault, Electronic Learning Management Systems (ELM), and electronic quality systems.
• Strong understanding of GLP, GDP, GMP, regulatory requirements, and inspection readiness practices.
• Must have Lead Auditor Certification & experience in conducting audits of suppliers and Contract Laboratories
• Must have faced regulatory audits like USFDA, EUGMP & WHO etc.

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