Manager - Quality Control, Operation Support

Position Summary:

• Work Schedule: M-F 8am-5pm
• 100% on-site

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.

• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, GM Excellence, and GROW) may be considered in place of external experience.

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!