Director of Quality

Mile High LabsLoveland, CO
4d$120,000 - $145,000

About The Position

Join a pioneering company at the forefront of the hemp-derived cannabinoid industry that powers the world’s novel consumer packaged goods, where your quality leadership will directly shape products trusted by leading global brands. As one of the industry's most trusted leaders with best-in-class manufacturing certifications, you will have the autonomy and resources to build world-class quality systems while working with a collaborative team that values innovation and scientific rigor. This is a rare opportunity to make your mark in a growing global sector where your expertise will be valued, your voice will be heard, and you will play a critical role in setting industry standards. The Director of Quality is a critical member of Mile High Labs (MHL) operations function. Leading a team of Quality personnel and reporting directly to the Chief Operations Officer, the Director will be responsible for near- and long-term global quality, regulatory, and compliance matters of the Company. The Director will be charged with developing, implementing, and continuously improving systems, policies, and procedures to ensure MHL’s quality programs are a value driver for our partners and scalable to support our growing global business. The following job responsibilities are essential for the success of this position.

Requirements

  • BS in Science, Engineering, or related technical field required; advanced degree preferred
  • 10+ years in quality leadership within FDA-regulated manufacturing (pharmaceutical, dietary supplements, medical device)
  • 5+ years leading quality teams, including talent selection, development, and ongoing performance management
  • Deep expertise in 21 CFR Part 111 (dietary supplements) or equivalent pharmaceutical GMPs
  • Proven experience with regulatory agencies and third-party certification bodies
  • Track record of building scalable quality systems through significant growth

Nice To Haves

  • SQF certification experience
  • International regulatory experiences (Novel Foods, TGA, ANVISA, etc)
  • Hemp/Cannabinoid industry experience

Responsibilities

  • Leads the operation, maintenance, and evolution of MHL’s QMS to ensure compliance with all rules, regulations, and policies applicable to the manufacturing, packaging, storage, and distribution of all MHL’s products.
  • Ensures all MHL’s products, including its components and packaging, have appropriate and up to date specifications required for the purchase and manufacture of the same.
  • Manages the document control practices of MHL to ensure GMP compliance.
  • Leads the MHL quality department in the pursuit of continuous improvement of our quality systems and programs to support established and emerging global regulations.
  • Leads day to day quality operations while building tomorrow's infrastructure. Own material release velocity, batch record efficiency, and testing optimization. Eliminate quality-related production delays while strengthening our regulatory moat.
  • Maintains the regulatory compliance and good standing of MHL’s processing and holding facilities including, but not limited to, compliance with applicable GMPs, local, state and federal licensure.
  • With the assistance of external regulatory and legal resources, the Director will develop and maintain local and global quality and compliance strategies addressing different regions, where MHL’s products are sold.
  • Lead regulatory strategy for Novel Foods (UK/EU), FDA (US), PMDA (Japan), TGA (Aus/NZ), and emerging markets.
  • Position MHL as the regulatory intelligence partner across U.S. and international cannabinoid markets.
  • Maintain and expand critical certifications (GMP, NSF, Kosher) while anticipating future market opportunities.
  • Lead customer audits transforming compliance reviews into MHL’s competitive advantage.
  • Lead all internal and third-party audits while maintaining vendor compliance and regulatory documentation. Manage laboratory testing partnerships to ensure analytical accuracy, rapid turnaround, and cost-effectiveness.
  • Drive and optimize quality systems across Production and Supply Chain to improve efficiency and scalability while maintaining full regulatory compliance.
  • Ensure all MHL personnel are trained and proficient in applicable policies, standard operating procedures, methods and protocols necessary to support GMP compliance as well as consistent and reproducible manufacturing practices.
  • Lead root cause investigations and continuous improvement tools (CAPA, SPC, DMAIC) that turn quality failures into systematic process improvements.
  • Collaborate with R&D and executive leadership to identify, develop and pursue scientific and regulatory strategies that contribute to the Company’s goals and objectives.

Benefits

  • Comprehensive Benefits Package
  • Medical
  • Dental
  • Vision
  • FSA Benefits
  • 401K
  • Paid Time Off (PTO)
  • A great team environment
  • Entrepreneurial environment
  • Diverse and inclusive workplace where we all learn from each other
  • Ongoing training, development, and support for a career in the CBD/Cannabinoid industry.
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