Manager, Quality Control Support Services

Catalent; Kansas City (MO); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Competitive PTO

8 paid holidays

Medical, dental and vision benefits

Job summary

Catalent’s Kansas City facility is seeking a Manager, Quality Control Support Services to provide strategic and operational leadership for Stability, Sample Management, and electronic systems within the QC department. You will oversee teams, allocate resources, and ensure data integrity while supporting audits and regulatory inspections.

The role requires strong supervisory experience, deep cGMP knowledge, and a track record of continuous improvement.

Qualifications

• Bachelor's degree in a life science or physical science field with 7+ years of pharma/quality experience, or a Master’s with 5+ years and prior supervision.
• Strong knowledge of cGMP requirements and data integrity principles.
• Experience leading and developing multiple teams and coordinating resources across Stability, Sample Management, and electronic systems.
• Ability to manage audits, inspections, and regulatory interactions with clear communication.

Responsibilities

• Lead Stability, LIMS/master data, and Sample Management teams including second shift; set priorities and monitor performance.
• Oversee sample lifecycle from receipt to disposition and destruction.
• Provide after-hours stability chamber support and issue resolution.
• Maintain GLIMS and Track-IT system compliance and inspection readiness.
• Ensure cGMP compliance and client commitments across activities.
• Develop and revise SOPs and controlled documents.
• Oversee capital expenditures, change controls, deviations, and investigations.
• Drive continuous improvement through team coaching and project leadership.
• Serve as escalation point for technical/compliance issues and audits.
• Assist in DEA clearance and controlled substance inventory verification.

Skills

Leadership

Project management

Quality systems

Data integrity

Regulatory compliance

Problem solving

Team development

Education

Bachelor's degree in life science or physical science

Master's degree in related field

Tools

LIMS

GLIMS

Track-IT

Job description

About Site

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses.

Position Summary

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.

Shift: Mon to Fri 8am-5pm

Location: Kansas City, MO

100% Onsite

The Role

• 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.

Minimum 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.
• On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds.
• Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently.

Preferred Skills & Background

• Not applicable

Why You Should Join Catalent

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• Competitive paid time off plus 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental and vision benefits effective day one of employment.
• Tuition Reimbursement.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [e-mail] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.

Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.

Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.