Enzene - Associate Director, Quality Systems

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 Associate Director, Site Quality Management Systems is a full time, in person position. This person will be responsible for implementing global systems at the new Enzene facility in Pennington, New Jersey. They will be accountable for the design and overall efficiency / effectiveness of the QMS process(es), along with driving global compliance and process performance. They will establish the governance structure and controls to ensure the QMS process is consistently applied across the company, ensure the health of the QMS process is continuously evaluated, and drive continuous improvement. The person in this role will also ensure compliance risks for the QMS process are understood and mitigated appropriately.

Key Responsibilities

• Establish and maintain compliant, risk-based and fit-for-purpose quality management system (QMS) process(es) and procedures ensuring effective implementation.
• Serve as the Owner for one or more (QMS) process(es), proactively monitoring and maintaining the health of the process and subprocesses and sustaining compliance with current and evolving global health authority requirements and regulations.
• Collaborate cross functionally with partners and stakeholders across different sites and functions is key for success in this role.
• Establish QMS process governance structure, leading and partnering with a matrix team. Collaborate with other global and site stakeholders to identify, define, and implement opportunities for improved QMS process workflows, while aligning QMS process with organizational goals and strategies. Promote knowledge sharing and the best practices.
• In collaboration with the BPMs, the Senior Manager QMS will ensure that these key processes are compliant, agile and support the business needs of the operations.
• Support Quality Management Review activities. Report and escalate compliance issues to management.
• Develop, maintain, and continuously improve global training curricula and course content for the QMS process(es), partnering with stakeholders on site/functional implementation.
• Provide oversight, support issue management, and drive continuous improvement as it pertains to the eQMS/system for the QMS process(es). Liaise with IT regarding system enhancements, driving effective prioritization in consideration of business and compliance impact. Lead and/or support implementation of eQMS/system enhancement and strategic projects.
• Responsible for tracking timely completion global compliance, deviation, and CAPA commitments.
• As needed, partner for Quality inspections with global Quality network with the goal of compliance to regulations and site harmonization. Provide SME support to site inspections, global inspections, and related observation responses.
• Other duties as assigned.

Requirements

Qualifications

• Education: Bachelor in Life Sciences discipline or related field.
• Experience: 8+ years of experience with Biotechnology, Pharmaceutical, Medical Device, or other highly regulated industry. Minimum of 5 years of experience as a people manager. Experience in Quality systems 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 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.