A biotech company in New Jersey is seeking a new Quality & Regulatory Business Partner to join their team.

About the Opportunity:
- Shift: Day
- Schedule: Full-time
- Hours: 40 hours per week
Responsibilities:
- Establishing relationships with business leaders for strategy alignment
- Serving as the primary contact for various business functions
- Participating in IT leadership to ensure governance and planning
- Staying up to date with emerging technologies
- Managing solution delivery and regulatory compliance
- Performing other duties, as needed
Qualifications:
- 10+ years of experience in IT leadership
- Bachelor's degree in Information Technology or related field
- Certification in relevant IT Management practices
- Strong knowledge of 21 CFR Part 11/Annex 11 compliance
- Experience with Computer System Validation (CSV) and GAMP5
- Ability to multitask in a dynamic environment
- Excellent leadership and negotiation skills
- Innovative and strategic thinker
- Strong communication skills
Desired Qualifications:
- 5+ years of experience in Vendor Management
- Master’s Degree in Business Administration or related field
- Certification in Project Management
- Experience with Drug Safety and Signal Detection
