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
Quality Systems Support & Lifecycle Management
- 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.
Come discover more about Otsuka and our benefit offerings; https://ah-prod.com/multi/videoplayer/player.html?v=6385356920112.
Join Our Talent Community: Stay connected with Otsuka by joining our Talent Community. Tell us about your interests, and we’ll notify you about future opportunities that align with your background. https://community.hireez.com/cielo-otsuka/82cb3591
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 EEAccommodations@otsuka-us.com.
Statement Regarding Job Recruiting Fraud Scams
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. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities.
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.
Bachelor's degree in life sciences, engineering, pharmacy, information systems, data/analytics or related field; 4+ years in pharmaceutical quality or related regulated environment; experience with eQMS platforms like TrackWise Digital or Veeva; strong GxP and ICH knowledge.
Key Responsibilities
- supporting quality systems
- optimizing workflows
- developing reports
Skills & Tools
TrackWise Digital, Veeva
Job Details
- Category: Quality Assurance
- Seniority: Mid Level
- Commitment: Full Time
- Workplace: Remote — United States
- Salary: USD 107,718 – 161,000 / year
- Languages: English
Benefits
- 401k matching
- Generous paid time off
- Tuition reimbursement
- Retirement plan
About Otsuka
A global healthcare company creating new products for better health worldwide, focused on neuroscience, nephrology, and digital medicine. — Industry: Healthcare