Head of Quality & Compliance / Director of Quality Assurance
Head of Quality & Compliance / Director of Quality Assurance
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Job Description
My client is seeking a Head of Quality & Compliance to lead all aspects of Quality Management and regulatory compliance. This role is pivotal to bringing safe non-addictive pain relief products to patients ensuring innovation never comes at the expense of safety or compliance. Youll be both the architect and hands-on driver of a forward-looking Quality function in a lean mission-driven environment.
Why You Should Apply:
Mission-driven company focused on non-addictive pain relief
Strategic ownership with hands-on impact in a lean dynamic team
Broad scope across QMS compliance regulatory engagement and partner oversight
- Comprehensive medical dental and vision benefits PTO holidays 401(k) with match and relocation support
What Youll Be Doing:
Own and lead the Quality Management System (QMS) and compliance programs
Review and approve critical quality documentation and manage CAPAs NCRs and product release
Serve as primary contact with FDA Boards of Pharmacy and other regulatory authorities
Oversee compliance with federal and state laws including MDRP 340B and transparency regulations
Manage quality oversight of CMOs CPOs and 3PL partners ensuring strict adherence to agreements
About You:
Be able to do the job as described
Thrive in a lean execution-first environment without direct reports
Comfortable serving as both strategist and hands-on executor
Experienced in regulatory compliance pricing programs and partner oversight
Confident in FDA and State Board inspection readiness and response
Required Experience:
Director
Employment Type
Full Time
