Otsuka Pharmaceutical Companies (U.S.) · 1 day ago
Director, Global Product Quality Assurance, Digital Products Development
United States
Full-time
Remote
Director/Executive
$161K/yr - $240K/yr
10+ years exp
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Responsibilities
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.
Qualification
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Required
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
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
Preferred
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
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
Paid leave programs
Other company provided benefits
Company
Otsuka Pharmaceutical Companies (U.S.)
There are two Otsuka pharmaceutical industry companies in the U.S.: Otsuka America Pharmaceutical, Inc.
1,001-5,000 employees
Funding
Current Stage
Late StageLeadership Team
Kabir Nath
Senior Managing Director, Global Pharmaceutical Business
Recent News
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