Senior Director, Quality Operations

About the Company

Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations. Cosette has a fast-growing portfolio of branded pharmaceuticals consisting of products in the cardiology, women's health, and migraine markets. The company has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions, and suppositories, leading to consistent supply to customers and commercialization success. Cosette operates corporate and manufacturing facilities in New Jersey and North Carolina and is supported by more than 300 dedicated employees across all functional areas.

About the Role

The Senior Director, Quality Operations will support quality initiatives and ensure compliance with cGMPs at the manufacturing facility.

Responsibilities

• Provides leadership and direction to the Quality organization.
• Mentor, oversee, and develop staff across Quality Assurance, Quality System, Quality Affairs, and Quality Control.
• Make decisions on key quality strategic and operational matters with significant, direction-setting impact on the company.
• Direct and control the activities and outcomes of Quality Assurance, ensuring organizational and product impact.
• Set and align goals and objectives for the Quality Assurance department with overall corporate goals.
• 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 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

Requirements

• Bachelor’s Degree or higher in life sciences, engineering, or business.
• 15+ years of 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 organizations, 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.