The Manager, Quality Systems is responsible for the design, implementation, maintenance, and continuous improvement of global quality systems that support compliance, operational excellence, and risk mitigation across the pharmaceutical product lifecycle. This role is pivotal in ensuring the effectiveness, compliance, and continuous improvement of core quality systems, including Inspections, CAPA, Change Control, Document Management, and Training. The ideal candidate will serve as a strategic partner to IT, enabling digital transformation and governance across the global quality landscape.
Key Responsibilities
- Quality Systems Management:
Lead the development, deployment, and governance of core quality systems (e.g., CAPA, Change Control, Deviation Management, Document Management, Training, Audit Management). Serve as the business process owner for quality system platforms, ensuring alignment with business needs and regulatory expectations. Lead or support global projects related to system implementation, validation, and lifecycle management. - Process Optimization:
Identify and implement process improvements to enhance efficiency, compliance, and user experience across quality systems. Drive process harmonization and standardization across global sites to ensure compliance with regulatory requirements (e.g., FDA, EMA, ICH, ISO). - Digital Transformation:
Partner with IT to define and implement digital solutions, system upgrades, and enhancements that improve usability, efficiency, and data integrity. - Governance:
Develop and maintain governance frameworks, including metrics, dashboards, and KPIs to monitor system performance and compliance. - Training & Change Management:
Support training initiatives and change management efforts to support global adoption of quality systems and processes. - Stakeholder Engagement:
Collaborate with cross-functional teams including Regulatory Affairs, Manufacturing, R&D, and Supply Chain to ensure alignment and integration of quality systems.
Qualifications
Required
Required Qualifications:
- Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or related field (Master’s preferred).
- Experience:
- 6+ years of experience in pharmaceutical quality, quality systems, or compliance.
- Proven experience implementing and managing global quality systems in a regulated environment.
- Experience with eQMS platforms (e.g., Veeva, TrackWise, ComplianceWire).
- Skills & Competencies:
- Strong knowledge of GxP, ICH guidelines, and global regulatory requirements.
- Excellent project management, analytical, and communication skills.
- Ability to lead cross-functional initiatives and influence without authority.
- Familiarity with Lean, Six Sigma, or other continuous improvement methodologies.
- Preferred Experience:
- Experience in global or matrixed organizations
- Knowledge of risk management frameworks (e.g., ICH Q9)
- Experience supporting regulatory inspections and audits
Preferred
- Experience in pharmaceuticals/medical devices or other regulated industry
- Embody a customer service mentality as you communicate and support field sales teams
- Experience leading Contract Workers remotely
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://www.otsuka-us.com/careers-join-otsuka.
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 Accommodation Request.
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Top Skills
What We Do
There are two Otsuka pharmaceutical industry companies in the U.S.:
Otsuka America Pharmaceutical, Inc. (OAPI) successfully commercializes Otsuka-discovered and in-licensed products in North America.
Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) clinically develops and registers innovative healthcare products on a global basis.
