Director of Quality Assurance (CDMO)

Job Title: Director of Quality Assurance

Location: Kansas - USA

Industry: Contract Research & Manufacturing

About the Role:

Our client, a rapidly growing and innovative pharmaceutical contract development and manufacturing organization (CDMO), is seeking an experienced Director of Quality Assurance to lead their Quality Operations. This role is central to the company's success as they scale their operations and expand their services, particularly in oncology, respiratory, and targeted drug delivery.

If you are looking for a leadership role with a dynamic company that combines the flexibility and excitement of a startup with the stability of a well-established organization, this could be the perfect opportunity.

Why This Opportunity?

• Growth and Development:
  Be part of a company that is on the cusp of major growth, with opportunities to shape the direction of the business and influence key decisions. The company is an early-stage organization with significant growth potential and high rewards for the right candidate, offering tremendous career growth opportunities.
• Work-Life Balance:
  Enjoy a primarily 8-to-5 work environment with a genuine commitment to work-life balance.
• Leadership and Influence:
  Join a close-knit, highly experienced leadership team where your voice will be heard. The Director of QA will be instrumental in steering the company through its next phase of growth, with the opportunity to build and manage a high-performing quality team.
• Innovative Technology:
  The company is a pioneer in particle engineering, with cutting-edge technologies such as their patented supercritical CO2 process, which is revolutionizing targeted drug delivery systems. You’ll work alongside some of the brightest minds in the field.
• Long-Term Rewards:
  This isn’t just a job—it’s a chance to be part of something bigger. In addition to a competitive salary, the company offers an equity compensation program.
• Location:
  Located in a family-friendly, university-centered community in the Midwest, the company is part of a vibrant college town with strong ties to local research and academic institutions.

 Key Responsibilities:

• Ensure the company’s full compliance with FDA cGMP/GLP regulations by implementing, maintaining, and optimizing systems and processes. This includes interpreting and navigating FDA regulations to support the company’s growth.
• Serve as the primary point of contact for regulatory agencies, ensuring compliance and managing inspections and audits.
• Oversee the development and implementation of quality systems, including internal audits, SOP reviews, and corrective actions.
• Foster a culture of client service and regulatory excellence, balancing the needs of both internal teams and external partners.
• Actively contribute to the company’s growth by building scalable, efficient processes.

What We're Looking For:

• A deep understanding of FDA regulatory requirements, particularly in cGMP/GLP settings.
• 10+ years of experience in Quality Assurance, ideally within pharmaceutical manufacturing or CDMO environments.
• Proven leadership skills, with a history of building and managing high-performing teams.
• Strong client-focused mindset with the ability to balance regulatory demands with customer service.

Our Client Offers:

• A competitive basic salary with benefits and equity compensation.
• A culture of flexibility, work-life balance, and a genuine commitment to employee well-being.
• An exciting opportunity to be part of a company on the cutting edge of pharmaceutical technology.

This is a search assignment being led by New Era Executive Search. To apply, please click apply, OR submit your resume to Byron.fitzgerald@neweraexecutivesearch.com,  referencing position code QA124.