Manager - Quality Control, Operation Support

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…