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.

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, adapt to new ways, and go with the flow; thrives in a small company atmosphere; demonstrate proficient cross-company communication, cultural sensitivity, and partnership in interactions with others. Responds resourcefully, flexibly, and positively when faced with new challenges, transitions, and demands. Moves forward productively and optimistically under conditions of change and uncertainty. Ability to take direction.

Physical Demands

• This job includes sitting, standing, walking, using hands/fingers for typing and handling documents, reaching, and maintaining close vision for computer work.

• This job functions in an open office setting using standard office equipment such as computers, phones, calculators, copiers, fax machines, and file cabinets.

• This job may require stooping, kneeling or crouching for accessing files in lower cabinets or performing other tasks.

Salary Range: $109,000.00 - $132,000.00 per year

Benefits:

• Health Insurance (Medical, Dental, Vision)

• Life and AD&D Insurance

• Disability Insurance (LTD & STD)

• 401k Retirement Plan

• Paid Time Off

Why Join Enzene?
At Enzene, we foster a collaborative and innovative environment where science and business intersect. Our team is dedicated to pushing the boundaries of biosimilar manufacturing, and we are constantly striving to improve processes and patient outcomes. Joining Enzene means being part of a company that values integrity, innovation, and collaboration in pursuit of scientific excellence.

We offer an environment of growth, learning, and opportunity in a sector that is driving change in healthcare.

Equal Opportunity Employer
Enzene is an equal opportunity employer, committed to fostering a diverse and inclusive work environment where all employees can thrive.