Quality Manager

General Responsibilities:

Primary responsibilities include providing oversight, leadership and management support to QA and QC operations. Responsible for monitoring and ensuring the quality of manufactured products. Measures, evaluates and applies the disposition of manufactured Bulk Drug Substance and Drug Product Injection lots, including generation of Certificates of Analysis.

Responsibilities:

• Manage a staff of QA Specialists and QC Analysts
• Track Bulk Drug Substance record review and disposition lifecycle
• Direct employees by assigning and maintaining timelines for product disposition
• Review of Quality Control testing data against established specifications
• Review and approval of Protocols and General Technical Reports
• Review and approval of Disruption to Controlled Environment (DCE), including data compilation
• Review and approval of Raw Material Specification (RMS) revisions
• Approve Change Controls
• Raise critical quality issues to upper management
• Write and revise Quality Systems SOPs as necessary to maintain compliance
• Assist in hosting regulatory inspections
• Monitor Quality Control programs and procedures to ensure compliance with compendial standards
• Verification of associated Quality documentation, as needed, ie, issuance of Batch Records, labels, etc.
• Training and development of employees

Computer Skills:

• To perform this job successfully, an individual should have knowledge of Database software; Project Management software; Spreadsheet software and Word Processing software.

Education:

• Minimum Bachelor of Science degree in a scientific discipline

Experience:

• Minimum five years of Quality experience in the biologics or pharmaceutical industry
• Excellent knowledge of CGMP guidelines, 21 CFR Parts 210 and 211 and other regulatory standards
• Writing experience in a similar role in the biologics or pharmaceutical industry
• Experience in aseptic processing and/or mammalian cell culture production considered a plus
• Flexibility and ability to adjust to changing priorities and unforeseen events using excellent time management skills
• Ability to execute multiple tasks
• Ability to work with a high degree of accuracy and detail
• Positive work attitude that supports teamwork and continuous improvement