Manager, Quality Control Support Services

Catalent seeks a Manager for Quality Control Support Services to lead Stability, Sample Management, and electronic systems teams at the Kansas City facility. The role involves strategic oversight of quality operations, compliance with cGMP requirements, regulatory interactions, and continuous improvement initiatives in a pharmaceutical contract manufacturing environment.

Responsibilities

• Lead and develop Stability, LIMS/master data, and Sample Management teams including second-shift operations; allocate resources and monitor performance
• Oversee sample lifecycle management including receipt, set-downs, pulls, distribution, shipping, disposition, and destruction
• Maintain compliance with cGMP requirements, client commitments, and site objectives across departmental activities
• Support after-hours stability chamber response, emergency support, and impact assessments with timely escalation and resolution
• Serve as technical and compliance escalation point; support customer interactions, audits, and regulatory inspections

Requirements

• Strong mathematical and scientific reasoning with ability to learn and retain technical information across multiple topics
• Comprehensive understanding of cGMP, regulatory guidance interpretation, and pharmaceutical quality best practices
• Advanced project management skills for multiple concurrent projects of moderate to high complexity
• Excellent written and verbal communication skills with ability to explain complex technical information to non-technical audiences
• Demonstrated leadership experience, team development capability, and recognition as a subject matter expert
• Ability to obtain DEA clearance and perform controlled substance inventory verification