Catalent
Pharmaceutical
Director,QualityEngineering
“Director, Quality Engineering at Catalent. Skills: Quality Engineering, GMP Compliance, Regulatory Affairs, Leadership. Lead GMP quality engineering strategies. Provide quality engineering oversight for manufacturing”
What You'll Achieve.
Ensure product quality; Ensure patient safety; Ensure regulatory compliance; Deliver regulatory confidence; Achieve operational excellence; Improve product quality; Improve operational efficiency
Industry & Context.
root cause analysis
What They're Looking For.
Must Have
Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, Industrial) or a related scientific discipline, Minimum of 10 years of progressive experience in a quality role within the pharmaceutical or biotech industry, at least 5 years in a leadership role, Deep technical expertise in GMP-compliant manufacturing environments, Thorough understanding of global regulatory requirements and standards (FDA, EMA, MHRA, PMDA), Experience leading quality transformation initiatives that deliver regulatory confidence and operational excellence, background in drug product manufacturing, preferably oral solid dosage forms, Ability to manage multiple projects and prioritize tasks in a dynamic environment, Excellent communication skills, both verbal and written, ability to write concise technical documentation
Nice to Have
Master's degree, Experience with PowerBi, CoPilot Studio, Agentic AI, Experience in softgel technology, Experience in ISO 13485, FDA 21 CFR Part 820, ASQ Certified Quality Engineer, Prior experience with BMRAM, Trackwise, Solid dosage or small molecule experience other dosage forms with relevant experience acceptable
What You'll Do.
Lead GMP quality engineering strategies
Provide quality engineering oversight for manufacturing
Apply Quality Risk Management principles
Oversee enhancement of change control system
Support deviation investigations
Strengthen data integrity controls
Develop risk-based monitoring and metrics
Drive digitalization and automation initiatives
Lead and mentor quality engineers
Drive continuous improvement initiatives
How You'll Work.
Team & Collaboration
Partner with cross-functional teams; Lead a group of quality engineers and validation specialists
Communication Scope
Excellent communication skills; verbal communication; written communication; write concise technical documentation
Process & Methodology
Manage multiple projects, Prioritize tasks
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