Quality Assurance/Quality Control Site-Level Lead, Superintelligence Infrastructure
OpenAI
Manager – Quality Management System and Document Services
OrganOx
full-time
Posted on:
Location Type: Hybrid
Location: Madison • New Jersey • 🇺🇸 United States
Visit company websiteSalary
💰 $140,000 - $150,000 per year
Job Level
Mid-LevelSenior
About the role
- Responsible for architecture of the Quality Management System and all infrastructure elements to affect an efficient and effective QMS and oversee, configure, and continually improve document management, change, and control processes.
- Report directly to the Director, Quality Assurance.
- Build organizational capability by leading, developing, and inspiring a global QMS and Document Services team; create clear pathways for professional growth and succession.
- Collaborate across functions (R&D, Operations, Clinical, Regulatory, IT, etc.) to embed QMS ownership and accountability throughout the organization.
- Act as a visible quality leader engaging senior stakeholders to align QMS and Document Services strategy with company objectives.
- Provide strategic oversight of document management, change control, and MasterControl-based processes and identify ways to streamline and strengthen compliance.
- Define and manage resource requirements and ensure the team is equipped to deliver against business and compliance needs.
- Champion the use of quality metrics to inform decisions, continuous improvement, and reporting to leadership.
- Represent Document Services and QMS functions in Management Review, audits, and inspections.
- Ensure compliance with relevant international regulations and continuously evaluate compliance risks, implementing mitigation strategies.
- Lead organization-wide initiatives to build capability and engagement with quality systems and ensure effective budget management.
Requirements
- A demonstrated record of success in Quality Management System oversight as demonstrated by successful regulatory audits and inspections.
- An expert-level knowledge of Software-based Quality Management Systems.
- An expert-level knowledge of Document Control and Change Management.
- Demonstrated proficiency in leading and developing successful transaction-based teams.
- Demonstrated ability to lead organization-wide change initiatives and management.
- High level interpersonal skills to both lead a team and to influence the wider organization.
- Minimum of a bachelor’s degree in a Life Science, Engineering or Technical subject.
- A minimum of 4 years of document control and change management experience in the Medical Device, Pharmaceutical or other regulated industry.
- Experience in eQMS systems such as MasterControl, TrackWise, Windchill or others is required.
- Experience in effective budget management and resource allocation is highly preferred.
- Strong knowledge of medical device standards and regulations such as: US 21 CFR 820 (QMSR), EU MDR 2017/745, SOR 98-282, TGA MDR 2002, and ISO 13485.
- Must have at least one year of experience managing direct report(s).
- Ability to travel internationally up to 10% annually.
Benefits
- The Pay Range for this position is $140,000 - $150,000 annually, with a 20% target annual bonus and benefits.
- Competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts.
- 401(k)-retirement plan with company matching after 90 days.
- Paid time off, holidays, and additional leave benefits.
- Employee discounts and access to our onsite wellness facility.
- Support for work-life balance and opportunities for ongoing professional development.
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Quality Management SystemDocument ControlChange ManagementeQMSMasterControlTrackWiseWindchillbudget managementresource allocationquality metrics
Soft skills
leadershipinterpersonal skillsinfluenceteam developmentorganizational change managementcollaborationstrategic oversightengagementcommunicationprofessional growth
