Director of Quality Assurance – Quality Management System
Catalent Pharma Solutions, Madison, WI, United States
Director of Quality Assurance — Quality Management Systems
Position Summary: 100% on-site in Madison, WI.
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.
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.
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.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
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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.
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.
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.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
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