Enzene - Quality Systems 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 Systems Lead to be responsible for responsible for providing quality oversight and operational support for US QA functions, including document review, deviation management, change control, audit support, and QMS reporting. This role will liaise closely with cross-functional teams in both India and the US to ensure compliance with cGMP and FDA regulations.

Key Responsibilities

• Manage the day-to-day operations in assigned area of Document Control. This includes establishing documentation around training, deviations, CAPA, and change controls.

• Own and manage meeting documentation and follow-up action items across all teams.

• Lead and oversee document control workflows, systems, and standards.

• Ensure staff are fully trained on all Document Control processes.

• Establish daily activity for the group to ensure quality results.

• Manages document control processes and systems for GMP activities in compliance with internal procedures, policies, and regulatory requirements.

• Establish and maintain the lifecycle of controlled documents, including but not limited to, quality records as defined in procedures, records management system including version control, document distribution, archival, retrieval, retention and destruction.

• Aid in defining resource requirements plans and prioritizes time in daily duties and responsibilities based upon business and compliance requirements.

• Involvement with implementation and management of an electronic Document Management System.

• Maintain labels and manuals and update, as necessary.

• Support Internal and External audits as needed.

• Other duties as assigned.

Qualifications

• Education: Bachelor in Life Sciences discipline or equivalent or equivalent experience.

• Experience: 6 years of experience in direct control of GMP systems and documentation. Master Control experience preferred.

• Skills: Proficient knowledge of GMP’s, FDA regulations and documentation procedures required, thorough knowledge of cGMP regulations, quality systems and regulatory requirements, Proficiency/knowledge with electronic management systems (such as QDMS, LMS, EDMS, and E-Doc) Advanced skills with MS Office applications and Adobe Acrobat, experience with Biotech startup environments.

• Comfortable and able to operate in a multi-cultural, multi-site environment. Able to communicate system implementation status for senior leadership. Able to explain application of cGMP regulations, quality systems and regulatory requirements for documentation system. Able to work professionally & productively in an open office environment.

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.