The Director, Quality Systems leads the development and implementation of systems and processes that support the quality and regulatory compliance goals of the company. This role champions continuous improvement of Quality systems and promotes awareness of regulatory and Quality Management System requirements, customer needs, and quality objectives throughout the organization. This individual will have knowledge of US and EU Medical Device and/or Drug Product quality regulations and standards, including 21 CFR Part 4, 21 CFR 820, ISO 13485, (EU) 2017/745, 21 CFR Parts 210 and 211, and EudraLex Vol. 4. Works collaboratively with Pharmaceutical and Device Manufacturing, Engineering, and other teams on Quality Management System execution, improvements, and efficiency. This role reports to senior Quality leadership.

 

Job Requirements

  • Develop, direct, and maintain key elements of the Quality Management System in compliance with FDA regulations, ISO standards, European regulatory requirements, and other applicable global requirements.
  • Drive continuous improvement of the Quality Management System to enhance compliance, efficiency, and scalability as the organization grows.
  • Own the CAPA process end-to-end, ensuring corrective and preventive actions are properly initiated, documented, tracked, evaluated for effectiveness, and closed in accordance with regulatory requirements and defined timelines.
  • Oversee additional core Quality System processes, including change control, document control, training, and internal audits, ensuring compliance with applicable regulations and company procedures.
  • Support regulatory inspections and external audits (e.g. FDA, Notified Body, etc.), including preparation, response coordination, and follow-up activities.
  • Act as system owner for the eQMS, overseeing system governance, configuration, and optimization in collaboration with IT and Quality stakeholders.
  • Contribute to computer system validation and qualification assessments and activities in collaboration with IT and system owners.
  • Ensure escalation to senior management of quality non-compliance or ineffective Quality System execution.
  • Lead and manage the Quality Systems team to achieve quality objectives.
  • Conduct internal audits and evaluations to ensure the company meets quality standards and regulatory requirements.
  • Collaborate effectively with cross-functional teams, including Manufacturing, Engineering, and senior leadership, to align quality processes with business goals.
  • Define, monitor, and present Quality System, Risk and Compliance metrics to senior management and lead Management Review activities.
  • May perform work as a Quality System Owner.
  • Additional duties as assigned.

 

Qualifications

  • Bachelor’s degree (preferably in Engineering, Quality Management, or a related field).
  • Minimum of 7 years of progressive experience in a GMP environment (medical device or pharmaceutical) with a focus on Quality Systems.
  • Proven leadership and management experience in Quality Assurance.
  • Strong understanding of pharmaceutical and/or medical device GMPs, regulatory requirements, and quality management systems.
  • Experience with electronic quality management systems and IT systems; experience leading or significantly contributing to the implementation or migration of an eQMS is preferred.
  • Familiarity with risk management methodologies (FMEA, hazard analysis) and integration into QMS processes for drug and/or device manufacturing.
  • Excellent problem-solving skills, attention to detail, and the ability to work individually or collaboratively in a team environment.
  • Demonstrated ability to drive accountability and deliver results in a regulated environment.
  • Ability to travel domestically and internationally, as required.
  • Lead Auditor or Auditor certification, preferred.
  • Experience working in combination product or complex regulated product environment is a plus.