Vice President - Quality and Regulatory

Forj Medical • Arden Hills, MN

5d

About The Position

Job Summary:The Vice President of Quality will develop and lead Forj Medical’s enterprise-wide global Quality strategy, ensuring compliance with applicable regulatory standards while driving operational excellence across the organization. This role is responsible for fostering a quality-focused culture throughout the entire organization. In addition, this role is pivotal in harmonizing quality systems post-integration and fostering a culture of continuous improvement to support patient safety and product integrity. Job Duties and Responsibilities: Strategic leadership and Integration: Define and execute the Quality vision aligned with Forj Medical’s business objectives and integration roadmap Serve as executive sponsor for Quality initiatives, including QMS harmonization and ERP integration Design and implement programs, policies and practices to ensure Quality Assurance and compliance Champion and embed a strong quality-focused culture, that matches our customer’s business and needs, throughout the organization Regulatory Compliance: Ensure adherence to FDA, ISO 13485, EU MDR, and other applicable regulatory standards Oversee compliance auditing programs to fulfill regulatory requirements Continuously monitor the regulatory landscape to identify laws and regulations that impact the company’s policies Culture, Engagement and Communication: Shape and sustain a cohesive values-driven culture across diverse operating environments Promote transparent communication and engagement strategies that reinforce organizational priorities Team Leadership and Development: Provide direct supervision and leadership to the Quality team, defining clear roles and reporting structures Facilitate cross-team collaboration and cultural alignment across teams and facilities Foster a high-performance, results-oriented culture and ensure continuous professional development of team members

Requirements

• 15+ years of progressive Quality and/or Regulatory leadership experience, including at least 5 years in a global senior leadership role
• Proven track record of leading post-merger/acquisition Quality integration
• Proven ability to build a quality-focused culture and manage large teams
• Experience in a medical device CDMO or life sciences contract services organization
• Experience with customer engagement and communication, from project-level to executive (C-suite), with the ability to balance Forj business and customer success
• Demonstrated executive leadership capabilities, including advanced communication, stakeholder influence, and the ability to build and lead high-performing global teams
• Strong financial and P&L management skills, with the ability to align quality strategies with overall business objectives
• Ability to travel approximately 20–30% to domestic and international locations
• Minimum of a bachelor’s degree (master’s degree preferred)

Nice To Haves

• Multi-facility leadership experience
• Executive experience leading organizations with institutional ownership (e.g., Private Equity)
• Prior experience presenting to boards of directors and shareholders

Responsibilities

• Define and execute the Quality vision aligned with Forj Medical’s business objectives and integration roadmap
• Serve as executive sponsor for Quality initiatives, including QMS harmonization and ERP integration
• Design and implement programs, policies and practices to ensure Quality Assurance and compliance
• Champion and embed a strong quality-focused culture, that matches our customer’s business and needs, throughout the organization
• Ensure adherence to FDA, ISO 13485, EU MDR, and other applicable regulatory standards
• Oversee compliance auditing programs to fulfill regulatory requirements
• Continuously monitor the regulatory landscape to identify laws and regulations that impact the company’s policies
• Shape and sustain a cohesive values-driven culture across diverse operating environments
• Promote transparent communication and engagement strategies that reinforce organizational priorities
• Provide direct supervision and leadership to the Quality team, defining clear roles and reporting structures
• Facilitate cross-team collaboration and cultural alignment across teams and facilities
• Foster a high-performance, results-oriented culture and ensure continuous professional development of team members

What This Job Offers

• Job Type: Full-time
• Career Level: Executive