Manager, QA
Assertio TherapeuticsIllinois, United States
Posted October 11, 2023
Full Time
About the Company
Assertio Therapeutics is a pharmaceutical company specializing in oncology, neurology, and pain management. We offer differentiated products with comprehensive commercial capabilities to address patients' needs. Our focus on supporting patients through targeted marketing distinguishes us in the industry.
Job Description
The QA Manager will oversee all quality aspects of CMOS products, ensuring adherence to cGMP, regulatory requirements, and internal procedures. This role involves approving batches, conducting audits, managing complaints, establishing systems, and advising risk management strategies. The position requires strong communication and collaboration skills with various stakeholders.
Requirements
- Approve master batch records
- Approve/reject commercial batches
- Provide guidance regarding manufacturing products
- Conduct audits of CMOs and suppliers
- Manage product complaints
- Establish/optimize quality systems
- Establish/maintain working relationship with CMOs
