Overview
Head of Quality Assurance Jobs in United States at Discover International
Title: Head of Quality Assurance
Company: Discover International
Location: United States
About the Company
A rapidly growing isotope production and advanced manufacturing organization is seeking a Head of Quality & Regulatory Affairs to lead enterprise quality strategy, regulatory compliance, and organizational quality excellence across a GMP-regulated manufacturing environment.
About the Role
This is a unique opportunity to build and shape the quality organization for a company undergoing significant growth and manufacturing expansion. The successful candidate will have direct influence on quality strategy, organizational design, inspection readiness, and the long-term quality roadmap. This role is ideal for a leader who enjoys building teams, developing future leaders, and creating scalable systems in a rapidly evolving manufacturing environment.
Responsibilities
- Develop and execute the organization's quality and compliance strategy.
- Lead and continuously improve the Quality Management System (QMS) across GMP operations.
- Oversee Quality Assurance, Quality Control, Compliance, Validation, and Inspection Readiness programs.
- Ensure successful execution of deviation investigations, CAPAs, change controls, and quality risk management activities.
- Act as the primary quality representative during customer audits, regulatory inspections, and strategic partner interactions.
- Support manufacturing expansion, technology transfer activities, process improvements, and commercial readiness initiatives.
- Build, mentor, and develop high-performing quality teams while creating succession plans and scalable organizational structures.
- Partner with executive leadership to establish a culture of quality, accountability, and continuous improvement.
- Serve as a key advisor to leadership regarding regulatory strategy, quality risk, and operational compliance.
Qualifications
- Bachelor's degree in a scientific, engineering, pharmaceutical, or related technical discipline.
- Significant leadership experience within pharmaceutical, biotechnology, radiopharmaceutical, isotope production, nuclear medicine, or other highly regulated manufacturing environments.
- Progressive leadership experience within Quality Assurance, Quality Systems, Compliance, or Regulatory Affairs.
- Strong knowledge of FDA regulations, cGMP requirements, quality systems, and inspection management.
- Demonstrated success leading regulatory inspections, customer audits, and compliance programs.
- Proven ability to build, scale, and develop quality organizations within growing manufacturing businesses.
- Strong executive presence with exceptional communication and stakeholder management skills.
Preferred Skills
- Isotope production, radiopharmaceutical manufacturing, nuclear medicine, radiochemistry, or radioisotope supply environments.
- Drug substance, API, biologics, or advanced therapy manufacturing.
- Experience supporting DMFs, INDs, NDAs, regulatory filings, or equivalent submissions.
- Multi-site manufacturing leadership.
- CDMO or contract manufacturing environments.
- Experience supporting commercial launches, facility expansions, and technology transfers.
Pay range and compensation package
Competitive compensation package including bonus and long-term incentives.
Equal Opportunity Statement
Mission-driven environment focused on advancing healthcare technologies. For confidential consideration, please contact Discover International.
