QMS Quality Specialist II

Position Overview

The U5 QMS Quality Specialist II  is responsible for overseeing and managing three key critical quality system processes at the site level: Deviations/OOS, Notification to Management (NTM), and Client Complaints. This role ensures compliance with global procedures, regulatory expectations, and client requirements while driving continuous improvement, maintaining system oversight, and serving as the site Subject Matter Expert (SME) for all three Quality System areas. This role plays a critical part in maintaining robust and inspection‑ready QMS, supporting operational excellence, and driving continuous improvement initiatives at the site

Key Responsibilities:

Non-Conformance Process Ownership

• Serve as the Business Process Owner and SME for Deviation/OOS, NTM, and Client Complaints.
• Collaborate with Global QMS teams to ensure alignment with global procedures and standards.
• Implement global and/or local processes and procedural updates to meet industry expectations.

Training & Development

• Develop, implement, and deliver training for Deviation/OOS, NTM, and Client Complaint processes.
• Support role-based training across departments and provide onboard training for new staff.

Metrics & Management Review

• Develop and implement KPIs for all three BPO processes.
• Track and report performance metrics for Management Review Meetings.
• Identify trends, risks, and improvement opportunities through data analysis.

Audit & Inspection Support

• Serve as SME during internal audits, client audits, and regulatory inspections.
• Provide required documentation, responses, and system walkthroughs.
• Support audit responses related to assigned processes

Deviation / OOS Management

• Oversee the full lifecycle of Deviation and OOS records, including initiation, assessment, investigation, and closure.
• Lead classification and initial impact assessment (Triage).
• Execute client notification requirements per Quality Technical Agreements (QTAs).
• Review Deviation/OOS records prior to client submission and obtain client approval before closure.
• Perform final QA approval in AQEM and manage record extensions as needed.
• Maintain the U5 Deviation/OOS master log and pull system reports as required.

Notification to Management (NTM)

• Oversee the NTM process, ensuring timely reporting, escalation, and closure.
• Coordinate NTM meetings, manage agendas, and document meeting minutes.
• Provide site-level support for NTM‑related inquiries.
• Maintain NTM records and logs in AQEM and generate reports as needed.

Client Complaints

• Oversee the end‑to‑end Client Complaint process, including initiation, investigation support, communication, and closure.
• Communicate with clients regarding complaint status, inquiries, and closure requirements.
• Maintain the U5 Client Complaint log and ensure documentation accuracy and compliance.

• Non-Conformance Process Ownership

  • Serve as the Business Process Owner and SME for Deviation/OOS, NTM, and Client Complaints.
  • Collaborate with Global QMS teams to ensure alignment with global procedures and standards.
  • Implement global and/or local processes and procedural updates to meet industry expectations.

  Training & Development

  • Develop, implement, and deliver training for Deviation/OOS, NTM, and Client Complaint processes.
  • Support role-based training across departments and provide onboard training for new staff.

  Metrics & Management Review

  • Develop and implement KPIs for all three BPO processes.
  • Track and report performance metrics for Management Review Meetings.
  • Identify trends, risks, and improvement opportunities through data analysis.

  Audit & Inspection Support

  • Serve as SME during internal audits, client audits, and regulatory inspections.
  • Provide required documentation, responses, and system walkthroughs.
  • Support audit responses related to assigned processes

  Deviation / OOS Management

  • Oversee the full lifecycle of Deviation and OOS records, including initiation, assessment, investigation, and closure.
  • Lead classification and initial impact assessment (Triage).
  • Execute client notification requirements per Quality Technical Agreements (QTAs).
  • Review Deviation/OOS records prior to client submission and obtain client approval before closure.
  • Perform final QA approval in AQEM and manage record extensions as needed.
  • Maintain the U5 Deviation/OOS master log and pull system reports as required.

  Notification to Management (NTM)

  • Oversee the NTM process, ensuring timely reporting, escalation, and closure.
  • Coordinate NTM meetings, manage agendas, and document meeting minutes.
  • Provide site-level support for NTM‑related inquiries.
  • Maintain NTM records and logs in AQEM and generate reports as needed.

  Client Complaints

  • Oversee the end‑to‑end Client Complaint process, including initiation, investigation support, communication, and closure.
  • Communicate with clients regarding complaint status, inquiries, and closure requirements.
  • Maintain the U5 Client Complaint log and ensure documentation accuracy and compliance.
• Other Duties as assigned

Qualifications

Education: Bachelor’s degree in a scientific or engineering discipline, or equivalent experience.

• Experience: six (6) years GMP industry and two (2) years Quality experience. Non-Conformance Management experience is preferred.
• Skills: Strong understanding of GMP principles and expectations, with the ability to apply them effectively in daily operations. Comprehensive knowledge of regulatory requirements relevant to pharmaceutical/biotech manufacturing and quality compliance. Proficient in Quality Systems processes, including their purpose, interdependencies, and execution in a regulated environment.
• Communication: Demonstrated ability to lead, influence, and communicate across multi site, multi cultural teams. Capable of clearly explaining, coaching, and supporting cross functional teams through Non-Conformance Management processes and best practices. Able to articulate and defend Deviation/OOS, Client Complaints and NTM rationale, and compliance expectations during internal and external audits.

Physical Demands:

• This job function is an open office setting using standard office equipment such as computers, phones, calculators, copiers and file cabinets

Salary Range: $70K to $86K Annually

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.