Catalent
pharma, biotech, self-care
Manager,QualityControl
Neural analysis suggests this role is
optimal for Manager candidates.
“Manager, Quality Control at Catalent. Skills: Quality Control, Leadership, cGMP, Process Management, Cross-functional Coordination, Vendor/Stakeholder Management, Operational Metrics, Resource Planning, Continuous Improvement. organizing and supervising daily Quality Control activities. ensure testing schedules are executed as planned”
What You'll Achieve.
ensure testing schedules are executed as planned; maintain a compliant quality environment; support on-time delivery of drug product; meet production goals, quality and cost objectives; Set and ensure a regular follow up of the individual SMART objectives
Industry & Context.
Good problem solving and organizational skills; Provide support to analyst in troubleshooting QC testing methods and instruments; Assist in OOS investigations
100% on-site, required visual acuity testing (including Graham Field Eye Test Chart and Ishihara Color Vision Test)
What They're Looking For.
Must Have
minimum of 8 years of experience working in a cGMP QC laboratory (with Bachelor's), minimum of 6 years of experience working in a cGMP QC laboratory (with Master's), 2 – 4 years of Progressive Leadership experience, experience with Performance Management, experience with Goal Setting, experience Managing through Conflict, Skilled in Instrument qualification, Skilled in method Validation, Skilled in Aseptic technique, cGMP compliant lab experience, Writing, Excel, Word and Power point skills, Excellent understanding of Quality Assurance and Quality Management Systems to ensure adherence to cGMP requirement and SOP's, Ability to foster a culture of continuous improvement and excellence in the QC laboratory area, Outstanding leadership and management capabilities to build, motivate and manage a team, Good problem solving and organizational skills, written and verbal communication skills in English, ability to work cross‑functionally under tight timelines, manage multiple priorities with high attention to detail, willingness to successfully complete required visual acuity testing (including Graham Field Eye Test Chart and Ishihara Color Vision Test)
Nice to Have
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.
What You'll Do.
organizing and supervising daily Quality Control activities
ensure testing schedules are executed as planned
support investigations
support documentation
support audit readiness
informing QA of any quality issues arising from analytical or microbiology testing
maintain close communication with Manufacturing and Supply to support on-time delivery of drug product
collaborate with Facilities to report instrument issues and coordinate repairs
and other required instrument interventions
Coordinate the QC lab activities to meet production goals
quality and cost objectives
Provide support to analyst in troubleshooting QC testing methods and instruments
Supervise daily QC activities and ensure schedule is followed
microbiological and raw material dossier review
Review all QC forms and logbooks used for daily operations
Assist in OOS investigations
Assist in instrument qualifications
Lead training of QC analyst
Execute Method Validation
Microbiological and Raw Material Test
Author and revise QC lab documents such as SOP
Protocols and Reports
Set and ensure a regular follow up of the individual SMART objectives in collaboration with the members of his/her team
Implement/ Execute the company strategy and organizes the activities within his/her team
Measure the performance of his/her team
Share relevant information and communicates with his/her team
Develop each team member's autonomy and expertise
through training and any other development opportunity mainly
How You'll Work.
Team & Collaboration
partners closely with Quality Assurance; maintains close communication with Manufacturing and Supply; collaborates with Facilities; Set and ensure a regular follow up of the individual SMART objectives in collaboration with the members of his/her team; Share relevant information and communicates with his/her team; Develop each team member's autonomy and expertise, through training and any other development opportunity mainly; work cross‑functionally under tight timelines
Communication Scope
written and verbal communication skills in English
Process & Methodology
resource planning, manage multiple priorities
Full Job Description
**Manager, Quality Control** ** _Position Summary:_** * **Work Schedule: Monday – Friday, 8:00am-5:00pm.** * **100% on-site** Catalent is a leading global CDMO, trusted by pharma, biotech and self-care companies to accelerate the development, manufacturing and delivery of products that improve lives. With advanced technologies, deep expertise and a worldwide network, we partner with innovators to transform bold ideas into life-changing therapies and self-care solutions. Our U.S. commercial cell therapy manufacturing facility is located in Princeton, NJ, and is part of Catalent’s cell therapy network including our European Center of Excellence for cell therapy in Gosselies, Belgium. The Manager, Quality Control is responsible for organizing and supervising daily Quality Control activities to ensure testing schedules are executed as planned. This role partners closely with Quality Assurance to maintain a compliant quality environment, including supporting investigations, documentation, audit readiness, and informing QA of any quality issues arising from analytical or microbiology testing. The Manager maintains close communication with Manufacturing and Supply to support on-time delivery of drug product and collaborates with Facilities to report instrument issues and coordinate repairs, calibrations, and other required instrument interventions. The Manager, Quality Control, reports to the Director, Quality and is responsible for leading and managing a team of Quality Control Scientists. **_The Role:_** * Coordinate the QC lab activities to meet production goals, quality and cost objectives. * Provide support to analyst in troubleshooting QC testing methods and instruments. * Supervise daily QC activities and ensure schedule is followed. * Perform analytical, microbiological and raw material dossier review. * Review all QC forms and logbooks used for daily operations. * Assist in OOS investigations. * Assist in instrument qualifications. * Lead training of QC analyst. *
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