Manager, Quality Control Support Services

Catalent Pharma Solutions; Kansas City (MO); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Tuition Reimbursement

Paid holidays

Career growth opportunities

Job summary

Catalent is seeking a Manager, Quality Control Support Services in Kansas City to lead Stability, Sample Management, and electronic systems teams, ensuring cGMP compliance and data integrity. You will drive audits, client interactions, and continuous improvement initiatives.

The role requires strong leadership, extensive QA/CMC knowledge, and the ability to balance strategic oversight with hands-on escalation support across multiple departments.

Qualifications

• Bachelor’s degree in life sciences or related field with 7+ years pharma/quality experience, or Master’s with 5+ years and prior supervision.
• Strong mathematical and scientific reasoning; ability to interpret diverse instructions across multiple teams.
• Extensive knowledge of cGMP and pharmaceutical quality practices; ability to defend positions with regulatory agencies.

Responsibilities

• Lead Stability, LIMS/master data, and Sample Management teams (including second shift) and allocate resources.
• Oversee sample lifecycle from receipt to disposition and destruction, ensuring timelines.
• Support after-hours stability chamber alarms, emergency support, impact assessments, and escalations.
• Maintain GLIMS and Track-IT system compliance, data integrity, and inspection readiness.
• Develop and revise SOPs and controlled documents; manage CAPEX, changes, deviations and investigations.

Skills

Leadership

cGMP

Quality systems

Regulatory understanding

Project management

Data integrity

Education

Bachelor’s degree in science

Master’s degree in related field

Tools

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.

The Candidate 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.
• Understand 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 offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life‑saving and life‑enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work.

Equal Opportunity Employment

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

Accommodation Requests

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.

Agency Notice

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.

California Job Notice

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

Massachusetts Notices

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.

About Catalent

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life‑cycle supply. With time-tested experience in development sciences, delivery technologies, and multi‑modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life‑enhancing and life‑saving treatments for patients annually.