Job Description:

Reporting to the Senior Director of Quality Assurance or their designate, the QA Manager/Senior Manager:

• Collaborates with Manufacturing to enhance product quality through planning and process improvements.
• Supports internal and external audits, leading audits and providing comprehensive reports.
• Conducts assessments for changes to Quality Systems, overseeing document management, change control, and CAPA.
• Approves Deviations and CAPAs, ensuring thorough documentation and investigation.
• Serves as a Quality Subject Matter Expert, representing Quality in meetings.
• Works with manufacturing, clinical, and regulatory teams to ensure site quality.
• Oversees QA review of Batch Records and manages the SOP review process.
• Communicates regulatory changes effectively within the organization.
• Collaborates with Regulatory Affairs and Manufacturing to ensure regulatory compliance.
• Performs other duties as assigned.

Qualifications:

• Bachelor's degree in a scientific discipline.
• Minimum of 5 years of Quality Assurance experience, with at least 3 years in a management role.
• Proficient understanding of Quality Systems, cGxP requirements, and FDA regulations.
• Experience in preparing IND and BLA applications.
• Strong interpersonal skills and excellent communication abilities.