Director of Quality Assurance - Quality Management System
Catalent, Madison, WI, United States
Director of Quality Assurance – Quality Management Systems
100% on-site in Madison, WI
Position Summary The Director of Quality Assurance – Quality Management Systems at Catalent, Madison is responsible for all aspects of the quality assurance functions, ensuring compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements. Responsibilities include systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review for accuracy and compliance, and material disposition. QA safeguards all systems, processes, and actions to ensure regulatory compliance, essential for providing high quality drug products.
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, maintaining effective and professional communication between all parties, including the customer.
Supports the establishment, preparation, and communication of site quality metrics and 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
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
Catalent is an Equal Opportunity Employer, including disability and veterans.
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100% on-site in Madison, WI
Position Summary The Director of Quality Assurance – Quality Management Systems at Catalent, Madison is responsible for all aspects of the quality assurance functions, ensuring compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements. Responsibilities include systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review for accuracy and compliance, and material disposition. QA safeguards all systems, processes, and actions to ensure regulatory compliance, essential for providing high quality drug products.
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, maintaining effective and professional communication between all parties, including the customer.
Supports the establishment, preparation, and communication of site quality metrics and 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
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
Catalent is an Equal Opportunity Employer, including disability and veterans.
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