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Manager, R&D Quality Risk Management – Hybrid- Princeton, NJ
Join our client as a Manager, R&D Quality Risk Management, where you’ll play a pivotal role in overseeing computer system validation (CSV) activities across GxP systems. This position offers the opportunity to work in a highly regulated environment, collaborate cross-functionally, and ensure systems comply with evolving global standards in data integrity and compliance. If you thrive in a quality-driven, dynamic R&D environment, this is the role for you.
Location: Princeton, NJ – Hybrid
Compensation: This job is expected to pay about $60-$67/hour
No Visa Sponsorship Available for this role
What You’ll Do:
• Oversee CSV activities for GxP computerized systems and ensure alignment with global regulatory guidelines
• Provide expertise on 21 CFR Part 11, GAMP5, EU GMP Annex 11, and data integrity requirements
• Review and approve validation protocols, infrastructure qualification documents, and change controls
• Serve as the primary liaison between Quality, IT, vendors, and business units for CSV-related projects
• Support inspection readiness activities and contribute to continuous process improvement in quality systems
What Gets You the Job:
• Bachelor’s degree in computer science, engineering, life sciences, or a related field
• Minimum 5 years of experience in computer system validation within the pharmaceutical industry
• Strong knowledge of GAMP, Electronic Records/Electronic Signature regulations, and global data integrity standards
• Excellent project planning, organizational, and multi-tasking skills with a detail-oriented mindset
• Proficient in Microsoft Excel, Word, and Outlook, with strong communication and presentation skills
Apply now to join a forward-thinking team dedicated to maintaining excellence in quality and compliance.
If we are still actively screening for this role, our AI Recruiter, Avery, will email you an invitation for a virtual interview to learn more about your background and qualifications as they relate to this position. Candidates who align well with the job requirements may be submitted directly to our client for consideration.
Irvine Technology Corporation (ITC) connects top talent with exceptional opportunities in IT, Security, Engineering, and Design. From startups to Fortune 500s, we partner with leading companies nationwide. Our AI recruiter, Avery helps streamline the first step of your journey—so we can focus on what matters most: helping you grow. Join us. Let us ELEVATE your career!
Irvine Technology Corporation provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Irvine Technology Corporation complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities.