Director, Global Product Quality Assurance, Digital Products Development

About Otsuka Precision Health

Founded on Otsuka's rich history in delivering creative innovations for patients, Otsuka Precision Health (OPH) is the next step in our evolution. We are a health technology and services organization on a mission. And that mission is to get people the right interventions at the right time in their health journey through data and technology, applying the power of personal connection and deep, data-driven understanding of the patient condition. OPH is part of Otsuka Holdings.

Use your expertise to help us change the story on the health experience and how we can do our part to fix some of the fragmentation in care delivery. The time is now.

Job Description

Let's transform the health experience, one connection at a time, together.

The Director, Global Product Quality Assurance, Digital Products Development provides oversight and expertise to Otsuka Precision Health (OPH) in the interpretation and implementation of manufacturing and development regulations applicable to digital devices (SaMD) and other products. Ensure that SOPs describing internal processes are developed to maintain compliance with GxP regulations. You will contribute to to OPH's regulatory growth and standardization of quality processes therein.

• Develop OPH's Quality Management System for medical device hardware and SaMD product development in compliance with applicable U.S. Federal Regulations, ISO 13485 standards and other quality requirements.
• Lead design control and risk management activities and establish quality post-market surveillance activities for medical devices and oversee performance monitoring for non-regulated products.
• Lead the Quality Assurance team and collaborate with cybersecurity, risk management, design quality, IT security, and human factors teams to provide support for the commercial development and launch of digital devices and products.
• Collaborate with product development teams to integrate quality into product development, and deployment.
• Support the Total Product Lifecycle as a contributing member, ensuring adherence to quality requirements.
• Support internal and external audits, respond to requests for information on quality activities, and serve as the quality lead for regulatory submissions, and engagement with regulatory agencies.
• Monitor and report metrics on quality and corporate compliance initiatives, ensuring continuous improvement.
• Support OPH engagement with FDA and other regulatory agencies.
• Support us on compliance programs.

Required Qualifications

• 10 years of Quality Management experience with GxP-compliant product development, manufacturing, and distribution
• Expertise in FDA 21 CFR Parts 820, Part 4 and ISO 13485
• 5 years of experience in internal/external auditing
• Manage supplier audits.
• Ability to manage team members and prioritize multiple tasks
• Experience in using MS Word, Excel, Electronic Document Management System and Access
• Experience with Agile Methodologies and Software Development
• Knowledge of HIPAA and GDPR

Preferred Qualifications

• Internal Auditor Certificate for 21 CFR 820/ISO 13485 quality management system
• Experience with ETQ
• Experience with tools like JIRA, ServiceNow, Salesforce and GRC tooling

Educational Qualifications

• Bachelor's Degree in Engineering or other Physical Sciences with 10 years of experience, or 15 years of regulated manufacturing and/or QA or QC roles

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.

Minimum $160,530.00 - Maximum $240,005.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.

Company benefits: comprehensive medical, dental, vision and prescription drug coverage, company provided Basic Life, AD&D, Short-term and Long-term Disability insurance, tuition reimbursement, a 401(k) match, PTO allotment each calendar year, 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.

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