About the Job

Quality Assurance and Regulatory Compliance Director

Location: Tri-State Area (able to travel to NYC, as-needed)

About the Role

Cabinet Health is seeking a highly experienced and mission-aligned Director of Quality Assurance and Regulatory Compliance to lead and scale a best-in-class quality and regulatory framework across our OTC, private-label, prescription, and white-label product portfolio. This role will ensure that the company is operating a quality program that exceeds regulatory requirements, maintains high-quality standards, and achieves customer satisfaction across all channels of the business. As a subject matter expert, you will provide guidance in areas related to quality, compliance, and regulations. You will champion a culture of quality across internal teams and external partners and play a key leadership role in inspection preparedness, operational integrity, and continuous improvement.

Remote-first but in-office at our Brooklyn, NYC office, as-needed. Travel to partner facilities, as- needed.

This role will report to the VP of Operations.

What You’ll Do

Regulatory Compliance:

• Ensure compliance with FDA, DEA, and other applicable regulatory requirements, including US, EU, Canadian, and Japanese guidelines.
• Oversee product registration and labeling activities to ensure alignment with regulatory guidelines.
• Serve as the primary contact for regulatory agencies and vendor partners, managing inquiries and inspections, audits of partners.
• Monitor changes in pharmaceutical regulations, guidelines, and standards and proactively mitigate potential compliance risks.
• Prepare the organization and vendor partners for regulatory inspections and audits, ensuring readiness and compliance.
• Serve as the Person Responsible for Regulatory Compliance (PRRC).

Quality Assurance:

• Establish and maintain a robust Quality Management System (QMS), overseeing the development, implementation, and maintenance of quality procedures, documentation, and records.
• Oversee quality control procedures for product categories across the supply chain.
• Drive the development of SOPs, work instructions, and training programs to enhance quality and regulatory compliance both internally and externally.
• Manage deviations, CAPAs (Corrective and Preventive Actions), and ensure timely resolution of quality concerns.
• Review and approve GMP/GLP/GCP documentation, including protocols, batch records, validation reports, and regulatory submissions, ensuring accuracy, completeness, and compliance with relevant guidelines.
• Conduct and review product and/or lot-related deviations, complaints, recalls, change controls, and Annual Product Quality Reviews (APQRs).
• Lead investigations into quality concerns, deviations, and non-conformances, implementing effective corrective and preventive actions to mitigate risks and prevent recurrence.
• Lead internal audits and quality reviews to ensure continuous improvement and compliance.
• Review, edit, and maintain all departmental SOPs, trainings, CAPAs, ECRs, and ECNs.

Operational Leadership:

• Collaborate closely with cross-functional teams, including operations, supply chain, and product development, to integrate quality and regulatory requirements throughout the product lifecycle.
• Provide regulatory oversight for new product development and launches.
• Actively participate in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained.
• Participate in developing, reporting, reviewing, and trending of GMP-related Quality Metrics such as Key Performance Indicators (KPIs) to identify risks and trends.

Manufacturing and Partner Verification:

• Evaluate, audit, and approve all manufacturing partners supplying medicines and co-packaging products to ensure compliance with quality standards and regulatory requirements.
• Develop and implement partner qualification and monitoring programs to maintain a portfolio of best-in-class suppliers.
• Build and maintain strong relationships with manufacturing and packaging partners to ensure ongoing adherence to contractual and regulatory commitments.
• Facilitate new supplier intakes, supplier qualifications, and update and maintain Quality Agreements with suppliers, ensuring partners uphold contractual and regulatory obligations.
• Support inspection preparedness activities within TG and CMOs.
• Represent Quality as Person-In-Plant at CMO facilities as necessary to support production operations.

Team Management:

• Build and lead a high-performing quality and regulatory team.
• Mentor and develop team members to ensure operational excellence.
• Foster a culture of accountability, transparency, and continuous learning.

Who You Are

• Minimum of 7-10 years of experience in quality assurance and regulatory affairs within the pharmaceutical industry.
• In-depth knowledge of FDA regulations, cGMP, and other relevant guidelines.
• Proven experience managing quality systems, audits, and regulatory submissions.
• Strong analytical and problem-solving skills with attention to detail.
• Highly adaptable and organized, able to leverage multiple sources and platforms to generate solutions.
• Proactive self-starter, always a few steps ahead.
• Effective and empathetic communicator.
• Highly detailed-oriented and able to dive into the weeds to achieve desired outcomes but also able to see the ‘bigger picture’ to drive decision making.
• Infinitely curious and excited to disrupt an antiquated industry.
• BS or BA degree.

Your Personal and Professional Values

• Highly motivated by Cabinet’s mission: to eliminate single-use plastic in medicine - making getting better, better through healthcare that is more sustainable, higher quality, and personal
• Trustworthy: dependable, prepared, and authentic
• Care-centric: care is at the center of everything we do, starting with care for ourselves, our team, and our communities. It goes beyond the medicines we sell.
• Growth-minded, growth-driven: progress over perfection is key for our company, our team, and our own personal development. We are looking for someone who is equipped to both relish in obstacles and excel in growth momentum.

Other Perks

• Competitive base salary + equity packages
• Full medical, dental, and vision packages
• Unlimited paid vacation policy
• Paid parental leave program
• Company sponsored development and wellness programs
• You’ll be part of an early start-up team and drive meaningful change to a rapidly evolving industry
• Summer Fridays - company office hours are closed after 2pm on Fridays during period between Memorial to Labor Day weekends