Quality Affairs Sr Director

American Regent Inc

Remote
Remote
Small molecule sterile injectable and lyophilized products
Cytotoxic large molecule sterile injectable and lyophilized products
Pre-filled syringes (pfs) and combination products
American Regent Inc is seeking a Quality Affairs Sr. Director to lead quality compliance for pharmaceutical production, ensuring adherence to regulatory standards and fostering a culture of quality. This remote position requires extensive experience in quality assurance and management within the pharmaceutical industry

Job Summary

  • The Quality Affairs Sr. Director serves as a key strategic leader with comprehensive responsibility for setting and driving the highest standards of quality across all phases of production and testing.
  • This role is accountable for establishing and maintaining rigorous compliance with all regulatory requirements and quality systems, ensuring excellence in laboratory operations, documentation, and management of Regulatory Body Inspections.
  • The Quality Affairs Sr. Director will champion strategic quality initiatives, spearhead continuous improvement processes, and cultivate a culture of quality throughout the organization.

Matching Summary

Match Score: 85

American Regent Inc is seeking a Quality Affairs Sr. Director to lead quality compliance for pharmaceutical production, ensuring adherence to regulatory standards and fostering a culture of quality. This remote position requires extensive experience in quality assurance and management within the pharmaceutical industry.

Skills & Requirements

Must-have

  • small molecule sterile injectable and lyophilized products
  • cytotoxic large molecule sterile injectable and lyophilized products
  • pre-filled syringes (PFS) and combination products
  • regulatory requirements and quality systems
  • laboratory operations, documentation, and management of Regulatory Body Inspections

Nice-to-have

  • champion strategic quality initiatives
  • cultivate a culture of quality
  • strong leadership and influence at all organizational levels

Key Requirements

  • Minimum 15 years progressive experience in pharmaceutical operations
  • Minimum 12 years leading functional quality assurance
  • Bachelors in Life Science or equivalent course of study

Work Rights

Not specified

Tailored Resume

Cover Letter