Manager - Quality Control, Operation Support
Position Summary:
Work Schedule: M-F 8am-5pm
100% on-site
Catalent's Core Biologics segment is a rapidly growing business within Catalent Pharma Solutions, dedicated to delivering innovative technologies and solutions that help bring more and better biologic treatments to patients. Our capabilities include the proprietary GPEx Lightning cell line engineering platform, a state-of-the-art biomanufacturing facility in Madison, WI, and a drug product development and manufacturing site in Limoges, France. By leveraging our differentiated technology portfolio, world-class manufacturing expertise, and integrated services across the Catalent network, Core Biologics is positioned for significant strategic growth.
Joining Catalent means becoming part of a talented, driven, and collaborative team. We are making substantial investments in people and capabilities, reflected in recent and planned expansions at our sites. This is a unique opportunity to contribute to a fast-growing business backed by a leading private equity firm, with strong potential for career development as we continue to scale. Our work has a direct impact on patients-delivering first-in-human therapies with speed and quality, supporting both clinical and commercial manufacturing to reach global populations. At Catalent Madison, our teams are advancing treatments for cancer, autoimmune and infectious diseases, fibrotic and blood disorders, HIV, diabetes, cardiovascular and pulmonary conditions, and neurological diseases such as Alzheimer's.
Catalent Pharma Solutions in Madison, WI is hiring a Manager - Quality Control, Operation Support. The Quality Control (QC) team is responsible for testing products, raw materials, and the manufacturing environment to ensure the safety, quality, identity, purity, and potency produced by the Catalent Madison Biologics facility. The QC team is comprised of the following groups:
Stability: Analytical testing, data analysis, document writing, and data reporting to support of ICH stability studies to determine the stability of bulk drug substance and drug product.
Sample Management: Management and oversight for all samples that support manufacturing, stability, and method validation. Also responsible for the management of stability chambers and oversight of laboratory critical reagents.
System Administration: QC enterprise level laboratory information management system (LIMS) and Empower administration and method building. QC stand-alone administration (e.g. user account management, data management, electronic method management, etc.).
Equipment Management: Responsible for activities related to equipment selection, qualification and validation, vendor management, maintenance, periodic review, change management, and retirement, and is performed in accordance with approved site procedures.
The Role:
Manage resources assigned to each functional area.
Ensure employee training is executed according to defined training plans and maintain current training plans.
Identify, maintain, and report functional KPIs to site management.
Monitor and report project milestone completion and timing.
Drive continuous improvement through leading cross function teams to address process improvement, system improvement, new regulations/expectations, new business needs, training improvements, and KPI performance improvements.
Maintain safe and healthy work environment by establishing and enforcing organization standards and adhering to legal regulations.
Take responsibility for direct reports' performance by setting clear goals and expectations, tracking progress against the goals, ensuring constructive feedback, and addressing performance-related concerns and issues promptly.
Work with, coach, and support direct reports in developing knowledge, skills, and abilities in the interest of performance improvement and employee's career development.
Accountable for daily operations to maintain Quality standards and project timelines, including execution of stability testing, coordination with stakeholders and communication with leadership.
Accountable for collaboration with internal Catalent stakeholders to complete stability analyses and reports, maintain effective and efficient processes, and ensure appropriate test directives are established and followed.
Accountable for monitoring stability protocol creation, stability sample pulls, testing completion, and stability report issuance.
Accountable for Laboratory Information Management System (LIMS) and Empower management. Work cross-functionally with corporate and site to enhance and manage QC enterprise systems.
Expand LIMS functionality with Laboratory Execution System (LES).
Maintain oversight of equipment status, availability, and suitability for analytical methods.
Ensure computerized systems associated with QC equipment are validated in accordance with data integrity and computer system validation requirements.
Ensure equipment and system changes are managed through change control, including evaluation of validation and regulatory impact.
Ensure QC laboratory equipment is properly maintained in compliance with GMP requirements, including enrollment and oversight of preventive maintenance, calibration, periodic review, and requalification activities, to maintain equipment in a validated and inspection-ready state.
Lead or support equipment decommissioning and retirement, including documentation of final disposition.
Other duties as assigned.
The Candidate:
Doctorate Degree in STEM discipline with minimum of 4 years related experience, OR
Master's Degree in STEM discipline with minimum of 7 years related experience, OR
Bachelor's Degree in STEM discipline with minimum of 9 years related experience, AND
Leadership experience minimum of 4 years.
Why you should join Catalent:
Defined career path and annual performance review and feedback process
Diverse, inclusive culture
Positive working environment focusing on continually improving processes to remain innovative
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
152 hours of PTO + 8 paid holidays
Generous 401K match
Medical, dental and vision benefits effective day one of employment
Tuition Reimbursement - Let us help you finish your degree or start a new degree!
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.
Visit Catalent Careers (https://careers.catalent.com/us/en) to explore career opportunities.
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 DisabilityAccommodations@catalent.com . 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 spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .
