Director, Global Product Quality Assurance, Digital Products Development

$160,530 - $240,005/Yr

Avanir Pharmaceuticals - State College, PA

Full-time - Senior

State College, PA

Chemical Manufacturing

About the position

The Director, Global Product Quality Assurance, Digital Products Development at Otsuka Precision Health (OPH) is responsible for overseeing and ensuring compliance with manufacturing and development regulations for digital devices and other products. This role involves developing and maintaining the Quality Management System for medical device hardware and Software as a Medical Device (SaMD), leading quality assurance activities, and collaborating with various teams to integrate quality into product development. The position also includes supporting regulatory submissions and engagement with agencies like the FDA, while monitoring quality metrics and driving continuous improvement.

Responsibilities

• Provide oversight and expertise in the interpretation and implementation of manufacturing and development regulations applicable to digital devices (SaMD) and other products.
• Develop OPH's Quality Management System for medical device hardware and SaMD product development in compliance with applicable U.S. Federal Regulations and ISO 13485 standards.
• Lead design control and risk management activities for medical devices.
• Establish quality post-market surveillance activities 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.
• Integrate quality into product development and deployment processes.
• Support the Total Product Lifecycle ensuring adherence to quality requirements.
• Support internal and external audits and serve as the quality lead for regulatory submissions.
• Monitor and report metrics on quality and corporate compliance initiatives.

Requirements

• 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 and managing 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.

Nice-to-haves

• 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.
• 401(k) match.
• PTO allotment each calendar year.
• Paid holidays.
• Paid leave programs.