Director of Quality Assurance - Quality Management System

Join an entrepreneurial team at Catalent Biologics in Madison, WI, and contribute to improving patient outcomes with life-saving and life-enhancing products. As the Director of Quality Assurance – Quality Management Systems, you will oversee quality assurance functions, ensuring regulatory compliance and safeguarding systems, processes, and actions. You will work with a team to develop knowledge, skills, and abilities, and lead the oversight, review, and approval of deviations and investigations.

Requirements

• Bachelor’s degree in STEM discipline with 15+ years’ relevant experience required; OR Master’s Degree in STEM with minimum of 12 years’ experience; OR PhD with 8 years’ experience
• Six (6) years of leadership experience required
• Excellent written and verbal communication skills with internal and external customers
• Ability to communicate complex technical information to non-technical audiences
• Able to combine and interpret data from multiple disciplines and has a commanding understanding of the full Biologics process
• Experienced in all aspects of drug development and lifecycle support, and able to develop useful strategies and tactics to meet regulatory milestones
• Demonstrable leadership experience at Catalent may be considered in place of external experience

Benefits

• Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance)
• Group Retirement Savings- Registered Pension Plan (RPP) with employer contributions
• Paid Time Off Programs including Vacation, banked time, and personal time
• Employee Reward and Recognition Programs
• Opportunities for professional and personal development