Catalent, Inc.
CDMO
AssociateDirector,Quality–BioAnalytical
“Associate Director, Quality – BioAnalytical at Catalent, Inc.. Skills: Quality functions within Biologics Analytical Services, High-quality analytical testing, Data integrity, Compliance across biologics programs. Lead key Quality functions within our Biologics Analytical Services (BAS) group. Oversee teams responsible for ensuring high-quality analytical testing, data integrity, and compliance across biologics programs”
What You'll Achieve.
High-quality analytical testing; Data integrity; Compliance across biologics programs; Functional KPIs to site management; Project milestone completion and timing
Industry & Context.
Address process improvement, system improvement, new regulations/expectations, new business needs, training improvements, and KPI performance improvements
100% on-site
What They're Looking For.
Must Have
Doctorate Degree in STEM discipline with minimum of 6 years related experience, Master's Degree in STEM discipline with minimum of 10 years related experience, Bachelor's Degree in STEM discipline with minimum of 12 years related experience, Leadership experience minimum of 5 years
Nice to Have
Experience leading a manufacturing site operation (e. g. Quality Operations, QC Operations, Manufacturing) is strongly preferred
What You'll Do.
Lead key Quality functions within our Biologics Analytical Services (BAS) group
Oversee teams responsible for ensuring high-quality analytical testing
and compliance across biologics programs
Responsible for all activities within one or more functional areas
Responsible for management of department Capex
Identify and support implementation of new technologies within the BAS Quality Department
Ensure employee training is executed according to defined training plans and maintain current training plans
and report functional KPIs to site management
Monitor and report project milestone completion and timing
Drive continuous improvement through leading cross function teams to address process improvement
new regulations/expectations
training improvements
and KPI performance improvements
How You'll Work.
Team & Collaboration
Drive continuous improvement through leading cross function teams
Communication Scope
Able to lead difficult discussions with customers and subordinates and drive the conversation to an acceptable resolution
Process & Methodology
Monitor and report project milestone completion and timing
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