Lonza
SeniorQualitySystems&ComplianceProjectManager
“Senior Quality Systems & Compliance Project Manager at Lonza. Skills: Quality Systems, Compliance, Project Management. Lead Quality QMS & Compliance projects. Drive proactive maintenance and development of Quality System”
What You'll Achieve.
Achieve sustainable compliance; Achieve site compliance goals
Industry & Context.
Ability to analyze data and extract the essence to drive change
What They're Looking For.
Must Have
Bachelor's or master’s degree in Life Sciences, Engineering or related field, Advanced experience in biopharmaceutical manufacturing experience and/or quality operations, plus quality systems working in a GMP environment, Experience with regulations (US, EU and other), Experience in a biopharmaceutical manufacturing environment or other relevant experience such as industries with high reliability needs, Experience in managing complex business setups and projects
Nice to Have
An additional background in business administration, project management, and Lean/Six sigma management is a plus
What You'll Do.
Lead Quality QMS & Compliance projects
Drive proactive maintenance and development of Quality System
Achieve sustainable compliance
Lead Compliance program at the site
Manage outputs from risk assessments
and quality escalations
Identify necessary QMS and Compliance projects
Drive improvements with functional areas
Achieve site compliance goals
Lead the implementation Quality improvement projects
Improve Quality performance and Compliance
Lead follow-up assessment from Health Authority
customer and internal audit observations
Lead lessons learned sessions
Implement inspection readiness actions
Train workforce on inspection readiness needs
Implement new or revised global Compliance programs and standards
Partner with functions to implement a Quality culture program
Scope & manage projects for QMS and Compliance needs
Partner closely with all assets and functions
Ensure proper deviation trending
Ensure root cause analysis is established
Ensure CAPA effectiveness is implemented
Act as a partner to Manufacturing Operations teams
Act as a partner to supporting teams
How You'll Work.
Team & Collaboration
Partner with functions at site to implement a Quality culture program; Partner very closely with all assets and functions; Act as a partner to the Manufacturing Operations teams; Act as a partner to other teams that support operations
Process & Methodology
Manage projects that focus on QMS and Compliance needs, Manage complex business setups and projects
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