Manager - Quality Management Systems

Manager - Quality Management Systems

Position Summary:

• Work Schedule: M-F 8am-5pm

• 100% on-site

Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.

Catalent Pharma Solutions in Madison, WI is hiring an Manager - Quality Management Systems. The Quality Assurance department 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 Quality Assurance Systems group has ownership over the quality systems, including deviations and CAPAs, change controls, document control, raw material testing and disposition, and training.

The Role:

• Provide oversight to ensure the Quality Systems are maintained in compliance with regulatory and customer requirements.

• Accountable for the Investigation and CAPA Management Systems and the Change Control Program.

• Responsible for managing complex and high-level deviations, supporting OOS investigations, and collaboration with internal Catalent stakeholders to support the effective execution of the Investigation and CAPA systems.

• Maintains and enhances effectiveness of the Quality System, including developing and reporting metrics, identification and implementation of improvement opportunities for established Quality Systems processes, procedures, and training to support Deviation, Out-of-Specification, CAPA and Change Control processes.

• Responsible for reporting and monitoring site wide metrics internally and to corporate on pre-defined basis.

• Responsible for presenting the status of the Quality System at the quarterly Quality Management Review.

• Develops and provides training to support consistent and effective execution of the Quality Systems.

• Serves as local TrackWise® Subject Matter Expert.

• Drives alignment and improvement initiatives, leading cross function teams, to address processimprovement, system improvement, and new regulations/expectations.

• Responsible for maintaining high level understanding of the Quality Management Systems and operations to provide oversight and decision making as appropriate in the absence of the QA Director.

• Provides technical assistance and training for personnel.

• Other duties as assigned

The Candidate:

• Doctorate Degree in STEM discipline with minimum of 4 years related experience,

OR

• Master's Degree in STEM discipline with minimum of 7 years related experience,

OR

• Bachelor's Degree in STEM discipline with minimum of 9 years related experience,

• Leadership experience minimum of 4 years

Why you should join Catalent:

• Defined career path and annual performance review and feedback process

• Diverse, inclusive culture

• Positive working environment focusing on continually improving processes to remain innovative

• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

• 152 hours of PTO + 8 paid holidays

• Generous 401K match

• Medical, dental and vision benefits effective day one of employment

• Tuition Reimbursement - Let us help you finish your degree or start a new degree!

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, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers ( to explore career opportunities.

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 View email address on click.appcast.io . 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.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to View email address on click.appcast.io for us to investigate with local authorities.

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