Director, Global Product Quality Assurance, Digital Products Development

4 weeks ago

Atlanta, Georgia, United States Avanir Pharmaceuticals Full time
About Otsuka Precision Health

Otsuka Precision Health (OPH) is a health technology and services organization dedicated to delivering creative innovations for patients. Our 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.

Job Description

The Director, Global Product Quality Assurance, Digital Products Development will provide oversight and expertise to OPH in the interpretation and implementation of manufacturing and development regulations applicable to digital devices (SaMD) and other products. This role will ensure that SOPs describing internal processes are developed to maintain compliance with GxP regulations.

The successful candidate will contribute to OPH's regulatory growth and standardization of quality processes. Key responsibilities include:

  • Developing 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.
  • Leading design control and risk management activities and establishing quality post-market surveillance activities for medical devices and overseeing performance monitoring for non-regulated products.
  • Leading the Quality Assurance team and collaborating 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.
  • Collaborating with product development teams to integrate quality into product development and deployment.
  • Supporting the Total Product Lifecycle as a contributing member, ensuring adherence to quality requirements.
  • Supporting internal and external audits, responding to requests for information on quality activities, and serving as the quality lead for regulatory submissions and engagement with regulatory agencies.
  • Monitoring and reporting metrics on quality and corporate compliance initiatives, ensuring continuous improvement.
  • Supporting OPH engagement with FDA and other regulatory agencies.

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.
  • 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.

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.

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