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Quality Assurance Director Job in USA 2026 with H-1B Visa Sponsorship

Quality Assurance Director Job in USA 2026 with H-1B Visa Sponsorship

Quality Assurance Director Job in USA 2026 with H-1B Visa Sponsorship

A senior executive opportunity is now open in Philadelphia, Pennsylvania, for a Quality Assurance Director – Radiopharmaceutical External Manufacturing with a leading global healthcare organization. The role offers a highly competitive annual salary ranging from $156,000 to $253,000, alongside performance bonuses and a comprehensive executive benefits package.

This is a strategic leadership position overseeing global radiopharmaceutical contract manufacturing networks across development and commercial stages. However, international professionals should note that this role does not offer H-1B visa sponsorship or employment-based visa support. Candidates must already possess unrestricted U.S. work authorization.

About the Role

The Quality Assurance Director will lead the global oversight strategy for radiopharmaceutical contract manufacturers (CDMOs), ensuring regulatory compliance, quality control, and operational excellence across early-phase development through commercial production.

This executive will partner closely with R&D, Global External Manufacturing, Corporate QA, and regulatory stakeholders to integrate radiopharmaceutical-specific quality requirements into broader corporate quality systems. The position carries responsibility for inspection readiness, third-party audits, quality risk management, and continuous improvement initiatives across a globally distributed manufacturing network.

In addition to regulatory leadership, the role includes organizational oversight, resource planning, team development, budget management, and engagement with global trade and pharmaceutical associations to help shape the evolving radiopharmaceutical regulatory landscape.

About the Employer

The hiring organization is a globally recognized healthcare and pharmaceutical leader headquartered in the United States, with operations spanning research, development, and commercialization of life-changing therapies worldwide. The company maintains a strong commitment to regulatory excellence, global compliance standards, diversity and inclusion, and employee development through structured leadership pathways and global mobility programs (where applicable).

Responsibilities

  • Develop and implement a global QA strategy for radiopharmaceutical contract manufacturing
  • Design and maintain phase-appropriate third-party quality oversight frameworks
  • Lead global CDMO qualification, auditing, and performance monitoring
  • Ensure GMP compliance across FDA, EMA, and other regulatory environments
  • Direct regulatory inspection readiness and agency engagement
  • Establish performance metrics and risk-based continuous improvement systems
  • Lead Quality Management Reviews and oversight trend analysis
  • Manage and develop a global QA leadership team
  • Integrate radiopharmaceutical standards into corporate global quality systems
  • Oversee budget planning and organizational resource management
  • Collaborate with trade associations to support regulatory evolution

Requirements

  • Bachelor’s degree in Life Sciences or a relevant pharmaceutical discipline
  • 10+ years of quality assurance experience in drug development and commercial therapeutics
  • Extensive expertise in GMP compliance across multiple global regulatory regions
  • Demonstrated experience leading third-party contract manufacturing oversight
  • Proven leadership of cross-regional QA teams and large-scale quality systems
  • Strong knowledge of FDA and EMA regulatory standards
  • Ability to travel internationally (15–20%)
  • Must have unrestricted authorization to work in the United States
  • Employer does not sponsor H-1B or other employment-based visas

Click Here to Apply

Conclusion

This Quality Assurance Director position presents a high-level leadership pathway within the U.S. pharmaceutical sector, offering substantial compensation and strategic global impact. International applicants seeking U.S. relocation should note that visa sponsorship is not available for this role; eligibility requires existing U.S. work authorization.

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