DUTIES:

• Senior Director of QA will be required to be a strategic thinker as you will be responsible for the build / design of facilities and developing both short-term and long-term master plans.
  
• As Director of Quality Assurance, you will be responsible for the quality systems at two
  
• You will be directing the processes for the approval and rejection of all materials, test methods, specifications, SOPs, work instructions, and protocols.
  
• Additionally, you will be required to meet domestic, international, and cGMP requirements for the manufacture and control of Phase 1-3 and commercial APIs and drug products.
  
• As QA Director, you will facilitate the development, implementation, and maintenance of procedures and policies to comply with FDA, EU, and ICH requirements applicable to API and drug product in all development phases up to and including commercialization.
  
• You will oversee the quality documentation systems to assure review and approval of Incident Reports, Change Control, and Investigations.
  

QUALIFICATIONS:

• BS or BA Degree with 15+ years, MS Degree with 10+ years, or Ph.D. with 5-8 years of industry experience in Quality Assurance Systems.
  
• Prior experience with strategic planning, building operations, or business operations is strongly preferred.
  
• Experience managing GMP and GLP quality systems and quality policies preparation.
  
• Extensive knowledge of FDA, EU, and ICH requirements and implementation for GLP and GMP in the pharmaceutical industry.
  
• Experience in quality systems and compliance for API and drug product.
  
• Minimum 5 years supervisory experience.
  

SUCCESS FACTORS:

• Demonstrate the capability for continued upward growth and technical contributions.
  
• Exceptional analytical and problem solving skills with the proven ability to think strategically.
  
• Highly effective team and interpersonal skills with the ability to work across numerous scientific and management disciplines.
  
• Excellent diplomatic, analytical, and communication skills both verbal and written.