Vice President - Quality and Regulatory

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

Qualifications and Requirements:

Required:

• 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)

Preferred:

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

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.

All positions are responsible for following applicable company policies and procedures as defined by their manager.

EEO Statement

Forj Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Employment Requirement

Must be authorized to work in the United States. 

Compensation and Total Rewards Package

The salary range for this position is outlined below under "Job Details" and is dependent upon the individual's skills, experience, qualifications, and applicable employment laws. Beyond base salary, Forj offers a competitive Total Rewards Package. We offer health, dental, vision, 401K plans, and time off programs. You may also be eligible to participate in an annual bonus program which depends on various factors, including, individual and organizational performance.