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Quality and Regulatory Director

Cabinet Health

Cabinet Health

Legal, Quality Assurance
New York, USA
Posted on Nov 22, 2024

About the Job

Quality and Regulatory Director

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

At Cabinet, we’ve been taking the healthcare industry by storm and have launched the world’s first sustainable, fully compostable, refillable medicine system. We’re on a mission to eliminate single-use plastic in medicine and are looking for a Production and Fulfillment Operations Manager to help us continue to bring sustainable products to customers reliably as we scale our retail, enterprise, and e-commerce channels.

About the Role

Cabinet’s Quality and Regulatory Director will be an integral part of the Cabinet team and will oversee all quality assurance and regulatory compliance activities across our product portfolio. This role will ensure that the company is operating a best-in-class quality program that exceeds regulatory requirements, maintains high-quality standards, and achieves customer satisfaction across all channels of the business.

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:

  • Develop and manage strategies to ensure compliance with FDA, DEA, and other applicable regulatory requirements.
  • Oversee product registration and labeling to ensure alignment with regulatory guidelines.
  • Serve as the primary contact for regulatory agencies and manage inspections, audits, and inquiries.
  • Monitor changes in pharmaceutical regulations and ensure the organization remains compliant.

Quality Assurance:

  • Establish and maintain a robust Quality Management System (QMS).
  • Lead internal audits and quality reviews to ensure continuous improvement and compliance.
  • Oversee quality control procedures for OTC and prescription medications, including private-label products.
  • Manage deviations, CAPAs (Corrective and Preventive Actions), and ensure timely resolution of quality issues.

Operational Leadership:

  • Collaborate with cross-functional teams, including operations, supply chain, and product development, to integrate quality and regulatory requirements.
  • Support new product launches by providing regulatory guidance and ensuring quality readiness.
  • Drive the development of SOPs, work instructions, and training programs to enhance quality and regulatory compliance.

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.

Team Management:

  • Build and lead a high-performing quality and regulatory team.
  • Mentor and develop team members to ensure operational excellence.

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.

About Cabinet

Cabinet began with a deep curiosity about how medicine was made and more importantly, how to improve it. Built on top of a supply chain with 3 generations of medicine manufacturing expertise, we’ve set out to provide high quality and fairly priced health essentials -- but we’re not stopping there. Our mission is to build the world’s most human and earth centric healthcare company. We offer batch-level tested and quality certified products, and are creating an innovative platform to provide content and care beyond a pill; one that’s also focused on the elimination of pharmaceutical packaging and pill waste. We hope you will join us on this journey.

Alongside cabinethealth.com, we retail with Amazon, Grove Collaborative, and national physical retail chains. Our investors are predominantly healthcare and consumer founders and operators, with institutional investment from SoGal Ventures, Global Impact Fund, and Techstars - all of whom prioritize societal and environmental impact alongside financial success. Our team has diverse experience in the top consumer startups and healthcare worlds. Cabinet Health’s headquarters are based in New York City (we meet quarterly in-person as a team.).

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
  • Shopping discounts for company products
  • Stipend towards cell phone/internet for work from home
  • 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