Senior Specialist - R&D Quality

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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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