Quality Control Expert 5

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Job description

This mgr will oversee 7 -8 people.
Very little travel
-80% on site and 20% remote
The QC Manager will be responsible for managing Microbiology Laboratory that supports the Carlsbad Viral Vector Manufacturing (CLD-VVM) facility in accordance with cGMP guidelines. This includes developing and driving appropriate performance KPIs, managing timelines and working with site stakeholders to successfully deliver customer deliverables while helping to maintain our production environment in a state of readiness.

In this role, the QC manager will also be responsible for overseeing all aspects of Material Qualification and BioChemistry testing at the Carlsbad Viral Vector Manufacturing Facilities (CLD-VVM) as a function of the overall Quality Control Department.

This role will work successfully, strategically, and tactically in a fast-paced, multi-disciplinary environment with potential for rapidly changing priorities. Additionally, ensure QC Laboratory compliance pertaining to the following regulatory agencies, such as: FDA, EMA, and the ability to follow ISO/EP/ICH and other related guidelines requirements, where applicable. This role also requires to: lead, manage and develop the team that supports the daily operations of the quality control group.

This position requires working with external entities (clients and testing laboratories) and provide technical expertise within the context of defining the problem statement, assessing the impact, identifying root cause, and determining corrective actions.

Ability to write and execute Bioburden Method Validation protocol, not limited to LAL Method Verification protocol. Proficient in leading protocol and special study executions.

Off-shift, weekend, duties may be assigned by the Head of Quality Control.

Minimum Qualifications:
•BS/Master's degree or higher in a scientific discipline.
•10+ years of experience leading a quality control organization
•Good understanding of governmental regulatory guidelines requirements relating to the manufacturing of biologics and pharmaceuticals
•Great Technical expertise in the following areas: Microbiology/Environmental Monitoring (EM) and BioChemistry
•Performing product inspections and facility inspections
•Able to travel nationally and or internationally
•Meet all pre-established testing requirements as set by MilliporeSigma
•Ability to perform moderate physical activities

Preferred Qualifications:
•Ph.D. degree in a scientific discipline
•7+ years of experience supporting client audits and regulatory inspections
•4+ years of Contract Manufactured Organization (CMO) experience
•3+ years of experience identifying, communicating, investigating, and driving quality system events to completion
•Knowledge of governmental regulatory guidelines, directives, and regulations relating to the manufacture of biologics and pharmaceuticals
•5+ years of experience working in a Cleanroom environment
•Experience performing internal and external audits
•Good communication and customer service skills required
•Knowledge of governmental regulatory guidelines, directives, and regulations relating to the manufacture of biologics and pharmaceuticals
•Ability to develop/optimize new processes and procedures
•Assume responsibility for compliance with safety guidelines
•Ability to work additional hours and weekend
•Ability to work, communicate well with internal and external departments