Enzene - Quality Operations Lead

About Our Client - Enzene
Enzene Inc. is an emerging Contract Development and Manufacturing Organization (CDMO) with a strong operational footprint in India. We are a subsidiary of Enzene Biosciences, a leading biotechnology company. Our mission is to provide high-quality biologics manufacturing services to our clients, contributing to the advancement of the pharmaceutical industry.

Website: www.enzene.com

Position Overview
We are seeking a Quality Operations Lead to be responsible for executing quality oversight activities for start-up of biologics manufacturing area operations, GMP warehouse, and QC laboratory. The position involves close collaboration with cross-functional partners, including Manufacturing, Quality Control, Regulatory Affairs, and Supply Chain, to ensure the consistent delivery of high-quality, compliant products. The QS Lead will also contribute to inspection readiness, internal audits, and continuous improvement efforts, ensuring Enzene remains aligned with evolving regulatory expectations and patient-focused quality standards. This role plays a critical part ensuring compliance with applicable GxP regulations, internal policies, and industry’s best practices.

Key Responsibilities

• GMP Operations Oversight: Provide day-to-day QA support for GMP operations, including Manufacturing, Quality Control, Facilities, and Materials Management, to ensure compliance with applicable regulations, internal procedures, and quality standards.
• Compliance Execution: Oversee timely and accurate QA review of GMP documentation, including batch records and QC data. Support batch disposition by ensuring all supporting documentation is complete, and compliant.
• Lead or support quality investigations, risk assessments, and CAPA development. Ensure all quality records are scientifically sound, closed on time, and aligned with regulatory expectations and internal policies.
• Represent the QA function during FDA, EMA, and third-party inspections, and serve as a QA subject matter expert as needed.
• Author, review, and approve SOPs, work instructions, and controlled documents. Support the implementation and continuous improvement of document control and change control systems.
• Use electronic quality systems (e.g., Veeva, TrackWise, or equivalent) to manage quality records, deviations, CAPAs, and workflows efficiently and in compliance with data integrity principles. Experience with Master Control preferred.
• Provide quality compliance with direction for validation and manufacturing activities. Serve as the quality liaison by providing compliance requirements for new product opportunities, including new equipment and technology.
• Promote a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.
• Demonstrates strong attention to detail Provide quality oversight and approval related to validation of processes, utilities, facilities, and equipment. Provide quality validation oversight to facility, utility, and equipment upgrades.
• Provide review and approval for qualification, validation, re-qualification, and re-validation documents for equipment and manufacturing process protocols, deviations, and final report.
• Ability to determine risk, identify appropriate solutions and deliver product-quality tasks and promote collaboration while working effectively with others across the organization to achieve goals.

Requirements

Qualifications

• Education: High school diploma or equivalent required; Associates/Bachelors degree preferred.
• Experience: Minimum of 6 years of direct experience in Operational QA role; Direct experience with GMP warehousing a plus; Minimum 8+ years of experience in a GMP Quality function at a Biotechnology or pharmaceutical organization; 4+ years’ experience in QA Operations/Material Disposition role; Vendor qualification and audit experience a plus.
  
• Skills: In-depth understanding of quality principles and GMP/ICH/FDA/EU regulations presented by the global health authorities. Good interpersonal skills and ability to work collaboratively and cross-functionally. Ability to complete risk assessment and resolve product quality issues. Technical knowledge of analytical method qualification and establishment of product specifications.
  
• A driven professional who knows how to work and contribute to an ever-changing working environment; willingness to learn new things, a