Director, QC Microbiology

Our clinical stage pharmaceutical company is growing and looking to add an Associate Director/Director, External QC Microbiology (REMOTE) to their team! This role will provide oversight of all external cGMP Microbiology, Environmental Monitoring, Virology testing. They will work in partnership with Technical Operations, Quality Assurance and external laboratories to assure that QC Microbiology, Environmental Monitoring, and Virology testing are performed in compliance with applicable regulations, company quality standards, and current industry practices. The responsibilities also include providing leadership for all microbiological aspects relevant to manufacturing, identifying and mitigating product quality, safety, and regulatory compliance risks, as well as working to establish internal Quality Control processes and procedures.

• Oversees the overall Quality Control Microbiology and Virology release testing strategy
• Ensures the Environmental Monitoring program at external manufacturing sites meet applicable regulatory requirements
• Ensures proper investigation into the root cause of product and/or process failures
• Leads OOS investigations, deviations, CAPA and change controls
• Provides support for all testing, tasks, and documentation in support of Validation Studies including Process Validation, Media Fills, Method Validation, and development of analytical methods
• Drafts and reviews appropriate sections of Regulatory submissions
• Interacts with agents from Regulatory agencies and participates in Audits and Inspections
• Supports the preparation of dossiers and data packages for interactions between Company’s and Regulatory agencies
• Writes and proposes revisions to Standard Operating Procedures, Analytical Methods, Technical Reports, and related Forms.
• Reviews and assesses proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate
• Liaises with other departments to ensure business continuity including Quality, Manufacturing, MS&T, Supply Chain, and Regulatory

Requirements:

• Minimum of a bachelor’s degree in biological sciences; advanced degree in biological sciences desirable
• A minimum of 8 years’ experience in a QC microbiology testing laboratory
• A minimum of 4 years’ experience in a management role
• Experience with coordinating QC testing at external contract laboratories
• Experience with aseptic manufacturing and biologics/vaccines
• Expertise in microbiology, virology and environmental monitoring testing
• Strong understanding of Quality Control testing requirements for pre-clinical, clinical, and commercial stage work.
• Comprehensive knowledge of compliance with cGMP regulations
• Highly skilled in root cause investigations, change control, and regulatory inspections
• Able to handle multiple projects and exercise good judgment in prioritizing tasks
• Excellent verbal, written and organization skills
• Ability to establish and maintain good working relationships with other functions and levels within the company and with external groups and organizations (vendors, investigators, regulatory authorities, and other stakeholders)

Other:

• Willingness to travel (20-25%) to various meetings or third-party sites, including overnight trips.
• Some international travel may be required.
• Location Remote-US East Coast preferred