The Senior Manager, Quality Assurance is responsible for the quality management of vendors and contractors to ensure compliance of manufacturing, testing, packaging, and release activities of Contract Manufacturing Organizations (CMOs).
Primary responsibilities include:
Conduct batch release activities for drug substance, drug product, and medical devices for all stages of development (Phase I - IV) and commercial product, including review and approval of Master Batch Records and executed batch records.
Interact with external contract manufacturers and testing laboratories and work as part of an internal multidisciplinary team to conduct, review, and approve manufacturing, testing, and product complaint investigations.
Perform activities to support the vendor qualification program.
Support management in developing, organizing, and maintaining the company's Quality Management System.
Bachelor's degree in a science or relevant related field
Minimum of 8 years in a Quality Assurance function within the medical products industry
Experience with performing Quality Assurance activities for development and marketed pharmaceutical products and/or medical devices
Experience with vendor management
Experience working within a Quality Management System
Working knowledge of Good Manufacturing Practices (GMPs)
Strong collaboration and leadership skills - ability to work both independently and as part of a team
Excellent communication skills, both oral and written
Cutanea Life Sciences is a specialty pharmaceutical company developing innovative technologies that will leverage intellectual property and therapeutic applications culminating in market-leading products to treat diseases and disorders of the skin and subcutaneous tissue. Please see our website at www.cutanea.com.