Enzene - Manager, Quality Operations

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
This is a full-time, on-site position. The Quality Operations Manager is 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 position 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 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.

• Foster a culture of accountability, technical excellence, and continuous professional growth aligned with Enzene’s mission and values.

• 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.

• Quality Records & Investigations: 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.

• Author, review, or approve SOPs, work instructions, and controlled documents for Operations and Quality Control groups.

• Electronic Systems Utilization: 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 direction for validation and manufacturing activities.

• Other duties as assigned.

Qualifications

• Education: Bachelors degree or equivalent in life sciences or related field.

• Experience: 8+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other highly regulated industry. Minimum of 3 years of experience as a people manager. Experience in Quality Operations required, with the following experiences preferred:

  • Biopharma experience in Quality Risk Management.

  • Knowledge and experience in GMP and GDP global regulations, principles, concepts, practices, and standards.

  • Prior experience and knowledge in Quality, Compliance, or a combination of experience such as Manufacturing, Quality, and/or Regulatory required.

  • Ability to work effectively in a matrix environment and drive results through “influence” as well as direct management.

  • Leadership, interpersonal, and communication skills and ability to influence diverse stakeholders and drive accountability and decision-making cross functionally.

  • Ability to present data and defend approaches in front of senior management and inspectors.

  • Ability to partner with other functional groups to achieve business objectives.

• Skills: This position requires knowledge and experience with quality operations processes and must possess leadership qualities and technical expertise in the areas of responsibility.

  • Strong technical background with previous experience working with eQMS and eDMS, Master Control experience is a plus.

  • Experience with working in start-up environments moving in a rapid growth/manufacturing.

  • Proficient in MS Word and Excel.

  • Understanding of GxP regulations including GMP, GCP, GLP, and PV.

  • Results oriented & self starter.

  • Can develop collaborative relationships to gain support and achieve results at all levels of the organization

• Communication: Strong written and verbal communication skills. Leadership, interpersonal, and communication skills and ability to influence diverse stakeholders and drive accountability and decision-making cross functionally. Read, write & understand English.

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: $128,000.00 - $154,000.00 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.