QA Sterility Assurance Manager

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Lonza Walkersville is IMMEDIATLEY hiring a QA Sterility Assurance Manager to maintain sterility assurance for LAL products, Aseptic Media Products and Cell Therapy Products.  Also interacts with Bioscience Media and LAL Operations and Cell Therapy Operations Management and QA leadership. Duties include QA oversight of Aseptic Processing Program, Environmental Monitoring and Microbial Control Policies for the Bioscience and Cell Therapy Operations departments. The QA Sterility Assurance Manager reviews policies, procedures and related completed media fill documentation, EM sample plans, cleanroom qualifications, EM excursions, deviations and sterility failures.  Also, review of sterile filter validations, integrity testing and procedures.

*This role offers a hybrid works schedule with 3 days on site at our Walkersville office and 2 days remote*

Key Accountabilities:

• Provide strategic plan and expertise for the development and implementation of the Microbial Control Strategy.
• Develop, document and manage microbial control strategy for Cell Therapy and Bioscience production processes from incoming raw materials through final product release.
• May manage a staff of 1 -2 specialists or provide guidance , oversight and support for Operations and QA specialists.
• Provide oversight and sterility assurance expertise to Bioscience and Cell Therapy Operations to assure aseptic processing meets US and international aseptic processing requirements (FDA Sterile Product Aseptic Processing Guidance and Eudralex, Annex 1, ”Sterile Medicinal Drug Products”, ISO 13408 and 21CFR820).
• Assesses facility and quality systems’ state of compliance with internal requirements and appropriate regulations and participates in the development of action plans to correct deficiencies and improve quality processes.
• Provides microbiological expertise to support EENs, deviations, CAPAs and Complaints related to aseptic processing.
• Supports regulatory and client audits as Aseptic sterility assurance  subject matter expert.
• Provide microbiological and sterility expertise for cGMP documents including, but not limited to, SOPs, batch records, media fill protocols, validations and specifications.
• Is knowledgeable and complies with all pertinent safety policies, rules and regulations.
• Ensure that all team members comply with safety rules and regulations.
• Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.

Key Requirements:

• Bachelor’s degree in s Life Science required; Master’s Degree in Microbiology, preferred.
• At least 5 years of GMP experience in the biologics industry required; 7 years direct QA experience and at least 3-5 years of management experience, preferred
• Some working knowledge of microbiological and sterility testing, media fills, environmental monitoring, clean room management, quality control endotoxin testing and microbiological control strategy required.
• Experience with oversight of aseptic processing and the associated international aseptic processing regulations is required.
• Experience in cell culture, cell or gene therapy experience is a plus.
• The ability to interface and communicate directly with clients may be required.
• Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects.
• Excellent written and oral communication to include accurate and legible documentation skills;
• Ability to work in a fast-paced environment; team oriented; independent work skills and a strong work ethic.