Catalent Biologics
Pharma
ManagerQualityManagementSystems
“Manager - Quality Management Systems at Catalent Biologics. Skills: Quality Management Systems, CAPA Management, Change Control, Process Improvement. Provide oversight to ensure the Quality Systems are maintained in compliance with regulatory and customer requirements. Accountable for the Investigation and CAPA Management Systems and the Change Control Program”
What You'll Achieve.
Ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements; Safeguards all systems, processes, and actions to ensure regulatory compliance; Ensure regulatory compliance; Providing high quality drug products for our clients and their patients
Industry & Context.
Investigation and CAPA Management Systems; OOS Investigations
100% on-site
What They're Looking For.
Must Have
Doctorate Degree in STEM discipline with minimum of 4 years related experience, Master's Degree in STEM discipline with minimum of 7 years related experience, Bachelor's Degree in STEM discipline with minimum of 9 years related experience, Leadership experience minimum of 4 years
What You'll Do.
Provide oversight to ensure the Quality Systems are maintained in compliance with regulatory and customer requirements
Accountable for the Investigation and CAPA Management Systems and the Change Control Program
Responsible for managing complex and high-level deviations
supporting OOS investigations
and collaboration with internal Catalent stakeholders to support the effective execution of the Investigation and CAPA systems
Maintains and enhances effectiveness of the Quality System
including developing and reporting metrics
identification and implementation of improvement opportunities for established Quality Systems processes
and training to support Deviation
CAPA and Change Control processes
Responsible for reporting and monitoring site wide metrics internally and to corporate on pre-defined basis
Responsible for presenting the status of the Quality System at the quarterly Quality Management Review
Develops and provides training to support consistent and effective execution of the Quality Systems
Serves as local TrackWise® Subject Matter Expert
Drives alignment and improvement initiatives
leading cross function teams
to address process improvement
and new regulations/expectations
Responsible for maintaining high level understanding of the Quality Management Systems and operations to provide oversight and decision making as appropriate in the absence of the QA Director
Provides technical assistance and training for personnel
How You'll Work.
Team & Collaboration
Collaboration with internal Catalent stakeholders; Leading cross function teams
Communication Scope
Presenting the status of the Quality System
Process & Methodology
Project review for accuracy and compliance
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