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.

Requirements

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: Stro