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.

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.

• Skills: This position requires knowledge and experience with quality assurance and quality management system 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. Understanding of GxP regulations including GMP, GCP, GLP, and PV

• Strong written and verbal communication skills. Experience with working in start-up environments moving in a rapid growth/manufacturing. Proficient in MS Word and Excel.

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

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: $155,000.00 - $182,000.00 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.