Manager, Quality Control

Catalent•Princeton, NJ

6d•Onsite

About The Position

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.

Requirements

Bachelor in a Life Sciences discipline with a minimum of 8 years of experience working in a cGMP QC laboratory OR Masters’ in a Life Sciences discipline with a minimum of 6 years of experience working in a cGMP QC laboratory.
2 – 4 years of Progressive Leadership experience, experience with Performance Management, Goal Setting and Managing through Conflict.
Skilled in Instrument qualification, method Validation, Aseptic technique, and cGMP compliant lab experience.
Strong 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.
Strong written and verbal communication skills in English, with the ability to work cross‑functionally under tight timelines, manage multiple priorities with high attention to detail, and willingness to successfully complete required visual acuity testing (including Graham Field Eye Test Chart and Ishihara Color Vision Test).

Nice To Haves

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.

Responsibilities

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.
Execute Method Validation, IPC, CFP, Microbiological and Raw Material Test.
Author and revise QC lab documents such as SOP, Specifications, 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.
Other duties are assigned.