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OrganOx · 1 day ago

Manager, Quality Management System (QMS) and Document Services

Madison, NJ

Full-time

Hybrid

Mid, Senior Level

$140K/yr - $150K/yr

4+ years exp

OrganOx is an innovative global medical device company focused on improving transplantation outcomes. The Manager of Quality Management System (QMS) and Document Services will lead a global team, oversee the QMS architecture, and ensure compliance with regulatory standards while fostering a culture of collaboration and excellence.

Health CareMedicalMedical Device

Responsibilities

Build, lead, and develop a high-performing global QMS and Document Services team, creating clear pathways for professional growth, capability development, and succession

Foster a culture of collaboration, accountability, and continuous learning, aligned with OrganOx's values of customer first, be passionate, uphold respect and think boldy

Act as a visible quality leader across the business, engaging with senior stakeholders to align QMS and Document Services strategy with company objectives

Drive organizational capability in document services by developing best practices, training programs, and cross-functional knowledge-sharing

Partner with leaders across functions (R&D, Operations, Clinical, Regulatory, IT, etc.) to embed QMS ownership and accountability throughout the organization

Adhere to the letter and spirit of OrganOx's Code of Conduct and all other company policies

Lead the architecture, design, and continual improvement of the OrganOx QMS to ensure compliance with all applicable regulatory and quality standards

Provide strategic oversight of document management, change control, and MasterControl-based processes, identifying innovative ways to streamline and strengthen compliance

Define and manage resource requirements, ensuring the team is equipped to deliver against business and compliance needs

Champion the use of quality metrics, ensuring data-driven insights inform decisions, continuous improvement, and reporting to leadership

Represent the Document Services and QMS functions in Management Review, audits, and inspections, demonstrating leadership and organizational maturity

Act as a collaborative cross-functional partner, promoting consistent, high-quality practices across global sites

Provide timely and evidence-based communication to the Executive Team, peers, and global colleagues

Ensure effective budget management and resource allocation in collaboration with the Director, Quality Assurance and other stakeholders

Lead organization-wide initiatives to build capability and engagement with quality systems, embedding compliance into daily operations

Proactively ensure compliance with all relevant international regulations, including US 21 CFR 820 (QMSR), EU MDR 2017/745, SOR 98-282, TGA MDR 2002, and ISO 13485

Serve as a key contact point during internal and external audits, providing leadership presence and demonstrating system excellence

Continuously evaluate compliance risks, implementing robust mitigation and improvement strategies

Qualification

Quality Management SystemDocument ControlChange ManagementEQMS systemsMedical Device StandardsBudget ManagementTeam DevelopmentInterpersonal SkillsLeadership Skills

Required

Minimum of a bachelor's degree in a Life Science, Engineering or Technical subject

A minimum of 4 years of document control and change management experience in the Medical Device, Pharmaceutical or other regulated industry is essential

Experience in eQMS systems such as MasterControl, TrackWise, Windchill or others is required

Must have at least one year of experience managing direct report(s)

Ability to travel internationally up to 10% annually

A demonstrated record of success in Quality Management System oversight as demonstrated by successful regulatory audits and inspections

An expert-level knowledge of Software-based Quality Management Systems

An expert-level knowledge of Document Control and Change Management

Demonstrated proficiency in leading and developing successful transaction-based teams

Demonstrated ability to lead organization-wide change initiatives and management

High level interpersonal skills to both lead a team and to influence the wider organization

Strong knowledge of medical device standards and regulations such as: US 21 CFR 820 (QMSR), EU MDR 2017/745, SOR 98-282, TGA MDR 2002, and ISO 13485; Knowledge of other relevant regulations and upcoming changes would be advantageous