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Director of Quality & Regulatory
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The Encompass Group
Denver, CO (In Person)
Full-Time
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Job Description
Director of Quality & Regulatory at The Encompass Group Director of Quality & Regulatory at The Encompass Group in Denver, Colorado Posted in 1 day ago.
D.) preferred. Minimum of 5 years of pharmaceutical quality and/or regulatory experience. At least 3 years of leadership experience managing and developing teams. Experience with pharmaceutical distribution, repackaging, APIs, or compounding supply chains is highly preferred.
Type:
full-timeJob Description:
Director of Quality & Regulatory Englewood, CO | Onsite The Encompass Group is partnering with a rapidly growing pharmaceutical organization for the search of a Director of Quality & Regulatory. This is an opportunity to join a highly specialized company serving the pharmaceutical compounding industry and help lead quality and regulatory operations during an exciting period of growth and integration. This role offers the chance to make a significant impact while developing teams, building future leaders, and partnering directly with executive leadership. Why This Opportunity? Join a growing organization operating in a highly regulated pharmaceutical niche. Work directly with company leadership and influence the future of the business. Lead and develop quality professionals while building career paths and succession plans. Become part of a culture that genuinely invests in people and promotes growth from within. Strong benefits package including employer-paid healthcare and a 4% 401(k) match. Relocation assistance available. Position Overview The Director of Quality & Regulatory will oversee quality assurance, compliance, and regulatory affairs for an FDA-registered pharmaceutical organization. This leader will ensure operational excellence, maintain regulatory readiness, and drive continuous improvement initiatives while developing and mentoring the Quality team. Key Responsibilities Quality Leadership Maintain and continuously improve the Quality Management System (QMS). Oversee CAPAs, deviations, change controls, investigations, complaints, recalls, and supplier qualification programs. Manage batch record review and product release activities. Ensure audit readiness and lead regulatory inspections. Drive continuous improvement initiatives and quality performance metrics. Regulatory Oversight Manage FDA registrations, DEA compliance, and state licensing requirements. Maintain compliance with cGMP, ICH
Q7, and DQSA requirements. Lead responses to FDA observations and regulatory findings. Partner cross-functionally with Operations and Supply Chain to ensure ongoing compliance. Team Development Lead and mentor Quality Specialists. Develop future leaders and establish career growth paths. Create a culture centered around coaching, accountability, and continuous learning. Build a strong succession plan and elevate team capabilities. Qualifications Bachelor's degree in Chemistry, Biology, Pharmacy, or another life science discipline required. Advanced degree (M.S. or Pharm.D.) preferred. Minimum of 5 years of pharmaceutical quality and/or regulatory experience. At least 3 years of leadership experience managing and developing teams. Experience with pharmaceutical distribution, repackaging, APIs, or compounding supply chains is highly preferred.