Director of Quality Assurance - Quality Management System

Director of Quality Assurance – Quality Management Systems

Position Summary:

• 100% on-site in Madison, WI

Working for Catalent Biologics is an opportunity to join an entrepreneurial team.  Catalent Biologics is making significant investments in people and capabilities.  This is a unique opening to join a small, fast-growing business, backed by a global company.  People joining our team will have the opportunity for career development as our business continues to grow and expand.  Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart, and lung diseases as well as Alzheimer’s.

The Director of Quality Assurance – Quality Management Systems is responsible for all aspects of the quality assurance functions at Catalent, Madison. The department’s primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements. This includes systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review for accuracy and compliance, and material disposition. Quality Assurance safeguards all systems, processes, and actions to ensure regulatory compliance, which is essential in providing high quality drug products for our clients and their patients.

The Role:

• Work with, coach, and support direct reports in developing knowledge, skills, and abilities in the interest of performance improvement and employee’s career development
• Manages the oversight, review and approval of deviations and investigations pertaining to CGMP production and testing.
• Understands the requirements of clinical and commercial programs for active pharmaceutical ingredients and bulk drug substances.
• Engages actively with Project Management and other department functions to ensure that CGMP programs are properly supported in order to achieve expectations; maintains effective and professional communication between all parties, including the customer.
• Supports the establishment, preparation, and communication of site quality metrics. Identifies and works
• with function areas as appropriate to facilitate improvements.
• Manages QA resources assigned to supporting quality systems, including investigations, change controls, raw material and consumable release, training, and document control.
• Manages the oversight, review and approval of deviations and investigations pertaining to utilities, facilities, equipment, material receipt and other general investigations.
• Other duties as assigned.

The Candidate:

• 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.
• Develops a team of quality professionals to support quality systems and investigation management objectives and ensure continual quality improvement.
• 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;  

Why You Should Join Catalent:

• 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.

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,