Manager, Quality Control Support Services

Catalent•Kansas City, MO

4d•Onsite

About The Position

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. We have an opportunity for a Manager, Quality Control Support Services to join our team. In this role, you will provide strategic and operational leadership for key functions within the Quality Control department, including Stability, Sample Management, and electronic systems. You will lead teams, allocate resources, and ensure compliance with cGMP requirements while promoting data integrity and continuous improvement. This position also serves as a technical and compliance escalation point and supports audits, inspections, and client interactions.

Requirements

Bachelor’s degree in a related life science or physical science field with at least 7 years of relevant pharmaceutical, laboratory, or quality experience, including a minimum of 1 year of direct supervisory or people-management experience; or a master’s degree in a related field with at least 5 years of relevant experience, including prior direct supervisory or people-management experience.
Able to proactively apply mathematical and scientific reasoning ability and learn and retain technical information on multiple topics.
Ability to interpret, provide, and manage a variety of instructions furnished in written, oral, diagram, or schedule form across multiple work groups.
Substantial breadth and depth of technical acumen in multiple techniques with significant expertise and understanding of their application in pharmaceutical service offerings.
Advanced project management skills for multiple concurrent projects of moderate to high complexity.
Ability to provide reliable interpretations of regulatory guidance and defend positions to regulatory agencies.
Well organized with ability to handle multiple activities simultaneously and learn unfamiliar principles or techniques quickly.
Comprehensive understanding of Good Manufacturing Practices and the pharmaceutical industry, with ability to apply quality and compliance best practices across functional areas.
Excellent written and verbal communication skills with internal and external customers, including ability to communicate complex technical information to non-technical audiences.
Ability to lead difficult discussions with customers and drive to resolution.
Lead by example according to Catalent's values and culture; able to organize and manage teams for issue resolution or special projects without management guidance.
Ability to assess training needs and help formulate development plans for junior members.
Recognized as a subject matter expert with high personal credibility; excellent motivator and team developer.
Understands how daily activities impact overall performance of group, site, and business; acts in the best interests of colleagues, patients, customers, and the organization.
Proactively identifies and assists in implementation of new technologies and understands their impact on Catalent offerings.
Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent‑sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

Nice To Haves

Not applicable

Responsibilities

Lead and develop the Stability, LIMS/master data, and Sample Management teams, including second-shift operations; establish priorities, allocate resources, and monitor performance and service levels.
Oversee the sample lifecycle, including receipt, set-downs, pulls, distribution, shipping, disposition, and destruction.
Support after-hours stability chamber alarm response, emergency support, sample impact assessments, escalation, and timely resolution.
Oversee GLIMS and Track-IT to maintain system compliance, data integrity, effective workflows, and inspection readiness.
Ensure departmental activities comply with cGMP requirements, client commitments, and site objectives.
Develop, review, and revise Standard Operating Procedures, work instructions, and other controlled documents.
Oversee departmental capital expenditure, PRG activities, change controls, deviations, investigations, and equipment or system implementation and qualification.
Identify, prioritize, and lead continuous improvement projects; coach team members in developing and implementing sustainable process improvements.
Serve as a technical and compliance escalation point and support internal and external customers, client visits, audits, and regulatory inspections.
Obtain required DEA clearance and assist in controlled substance inventory verification activities.
All other duties as assigned.