Senior Director, Quality Operations

Basic Purpose

The Senior Director, Quality Operations will support quality initiatives and ensure compliance with cGMP’s are maintained at the manufacturing facility.

Innovating every day.

• Provides leadership and direction to the Quality organization.
• Provide mentorship, oversight and development for the Quality Assurance, Quality System, Quality Affairs, and Quality Control staff.
• Makes decisions focused on key quality strategic and operational matters that have significant, direction setting impact on the company.
• Directs and controls the activities and outcomes of Quality Assurance which has a significant organizational and product impact.
• Sets and aligns goals and objectives for the Quality Assurance department with the overall corporate goals and objectives.
• Oversee preparation, coordination and execution of all regulatory inspections with the FDA or other regulatory agencies.
• Develop and maintain external relationships with key opinion leaders and regulatory officials.
• Direct the development of systems, practices, and processes to ensure effective ongoing review of product design and/ or manufacturing changes.
• Provide leadership and direction for significant deviation events that may impact compliance status or significant business risk.
• Oversee the functions of the analytical and microbiology laboratory, including:
  • Release of raw materials and components
  • In-process testing
  • Finished product release testing
  • Stability testing
  • Environmental Monitoring
• Review and approve quality documents, including:
  • Deviations
  • Annual Product Quality Reviews
  • Customer Complaints
  • Validation Protocols/Reports
  • Change Controls

• A Bachelor’s Degree or higher degree in life sciences, engineering, or business
• 15+ years pharmaceutical quality experience in a manufacturing, CMO, or life sciences technology driven company.
• Analytical and Microbiological proficiency related to the methodology of semi-solids drug products and associated excipients
• Extensive experience in cGMP and other Regulatory compliance requirements.
• Progressive and proven record of leadership and managing quality/ analytical organization’s establishing long term strategic growth initiatives.
• Experience with phases of the product development lifecycle, including concept, design, implementation, verification, and validation activities necessary for product commercialization.
• Ability to lead, influence, create and work within cross‑functional team environments.