Director of Quality Assurance - Quality Management System

Catalent • Madison, WI

5d • Onsite

About The Position

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.

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

Nice To Haves

• 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;

Responsibilities

• 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.

Benefits

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Dynamic, fast-paced work environment
• Community engagement and green initiatives
• Generous 401k match and paid time off accrual
• Medical, dental, and vision benefits effective day one of employment

What This Job Offers

• Job Type: Full-time
• Career Level: Director