Manager, Quality Systems

Otsuka America Pharmaceutical Inc.; Madison (WI); Remote; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical benefits

401(k) match

Paid holidays & time off

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Manager of Quality Systems to drive global electronic quality management system initiatives. This role focuses on Inspections, CAPA, Change Control, Deviations, and Audit Management while improving data governance and analytics.

The position requires partnering with Quality, IT, and analytics teams to translate business needs into system enhancements, dashboards, and digital capabilities across the lifecycle of pharmaceutical products.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Pharmacy, Information Systems, Data/Analytics, or related field.
• Master's degree preferred.

Responsibilities

• Support the implementation, maintenance, enhancement, validation, and lifecycle management of global electronic Quality Management System (eQMS).
• Partner with Quality process owners, IT, and other stakeholders to ensure system functionality supports processes and compliance.
• Support global system implementations, upgrades, enhancements, integrations, and other Quality technology initiatives.
• Provide centralized expertise to promote reliable, scalable use of Quality Systems across global functions and affiliates.
• Help identify system-related issues and coordinate solutions with stakeholders.

Skills

Quality Systems

GxP

Data Analytics

Stakeholder mgmt

Education

Bachelor's degree

Master's degree preferred

Tools

TrackWise Digital

Veeva

Job description

Remote

Full time

R13185

The Manager, Quality Systems is responsible for supporting the implementation, maintenance, optimization, and continuous improvement of global quality systems that enable compliance, operational excellence, data integrity, and effective decision-making across the pharmaceutical product lifecycle.

This role supports core quality processes and technology solutions, including Inspections, CAPA, Change Control, Deviations, Batch Review, and Audit Management, with a strong focus on enhancing system capabilities, optimizing workflows, strengthening data governance, and enabling meaningful reporting and analytics.

The Manager will partner closely with Quality process owners, IT, Data & Analytics, and cross-functional stakeholders to translate business needs into system enhancements, dashboards, reporting solutions, and emerging digital capabilities.

Key Responsibilitie

• Support the implementation, maintenance, enhancement, validation, and lifecycle management of global electronic Quality Management System (eQMS) solutions.
• Partner with Quality process owners, IT, and other stakeholders to ensure system functionality effectively supports business processes, compliance requirements, and evolving organizational needs.
• Support global system implementations, upgrades, enhancements, integrations, and other Quality technology initiatives.
• Provide centralized expertise and support to promote reliable, scalable, and consistent use of Quality Systems across global functions and affiliates.
• Help identify system-related issues, opportunities, and enhancement needs and coordinate solutions with appropriate business and technical stakeholders.

Process Optimization & Continuous Improvement

• Assess Quality System workflows and identify opportunities to improve efficiency, compliance, usability, and scalability.
• Support the harmonization and standardization of Quality System processes and workflows across global functions and affiliates.
• Facilitate requirements gathering, process mapping, future-state design, testing, and implementation of system enhancements.
• Apply continuous improvement methodologies to reduce unnecessary complexity, improve cycle times, and enhance the user experience.
• Monitor system and process performance to identify recurring issues, bottlenecks, and opportunities for improvement.

Quality Data, Reporting & Analytics

• Partner with Quality stakeholders to define meaningful metrics, KPIs, reports, and dashboards that provide visibility into Quality performance, compliance, risks, and emerging trends.
• Develop and maintain reports and dashboards using data generated through Quality Systems and related data sources.
• Support the ongoing maintenance, enhancement, and standardization of Quality reporting and dashboard capabilities.
• Partner with reporting, analytics, and technology teams to improve accessibility and usability of Quality data.
• Monitor and assess data quality and identify opportunities to improve completeness, consistency, accuracy, and usability.
• Partner with process owners and system stakeholders to resolve data quality issues and strengthen upstream data capture.

Digital Transformation, Automation & AI

• Partner with IT and business stakeholders to identify and implement digital solutions that enhance Quality System capabilities and productivity.
• Assess opportunities to leverage artificial intelligence, automation, advanced analytics, and emerging technologies within Quality processes and systems.
• Support requirement gathering across the business and evaluation of AI-enabled solutions.

Training, Adoption & Change Management

• Support change management and communications associated with Quality System implementations, enhancements, and process changes.
• Partner with Training and process owners to ensure users understand system functionality and associated business processes.
• Develop or support user guidance, communications, reference materials, and other tools that promote effective adoption.
• Gather user feedback to identify opportunities to continually improve system usability and support.

Stakeholder & Cross-Functional Collaboration

• Collaborate with stakeholders across Global Quality, IT, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Clinical, and other business functions to support integrated Quality System solutions.
• Translate business needs into clear system, reporting, analytics, and data requirements.
• Build strong relationships across global and matrixed teams and facilitate alignment among business, Quality, data, and technology stakeholders.
• Support global affiliates and functional teams in adopting standardized Quality System capabilities while appropriately addressing legitimate business needs.

Qualifications

Required Qualifications

Education

• Bachelor's degree in Life Sciences, Engineering, Pharmacy, Information Systems, Data/Analytics, or a related field.
• Master's degree preferred.

Experience

• 4+ years of experience in pharmaceutical Quality, Quality Systems, compliance, business systems, data/analytics, or a related regulated environment.
• Demonstrated experience supporting electronic Quality Management Systems and associated business processes.
• Experience with eQMS platforms such as TrackWise Digital, Veeva, or similar eQMS platforms.
• Experience supporting system implementations, enhancements, upgrades, integrations, or lifecycle management activities.
• Experience developing, maintaining, or supporting reports, metrics, dashboards, and data-driven performance monitoring.
• Experience working within global or matrixed organizations and collaborating across business and technology functions.

Skills & Competencies

• Strong understanding of GxP principles, ICH guidelines, and pharmaceutical Quality System expectations.
• Ability to translate business requirements into system, workflow, reporting, and analytics solutions.
• Strong process improvement and problem-solving capabilities.
• Excellent communication and stakeholder-management skills.

Preferred Qualifications

• Experience developing or supporting Quality dashboards and performance analytics.
• Understanding of AI, machine learning, generative AI, intelligent automation, or advanced analytics and their potential application within regulated Quality environments.

Competencies

Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.

Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.

Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.

Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.

Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.

Empowered Development - Play an active role in professional development as a business imperative.

Application Deadline

This will be posted for a minimum of 5 business days.

Company benefits:

Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Disclaimer

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting [e-mail].

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At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.

Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment.

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Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine.

Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.

OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023.

We invite you to explore our open positions for an opportunity to join our 2,200 colleagues in the U.S. whose passion for our mission and pride in our company have earned us certification as a Great Place to Work by the Great Place to Work Institute.