Location: Indianapolis, IN
Job Summary
The Sr. Manager, IT – GxP Computer Systems Validation & IT Process Lead is an integral part of bringing RayzeBio’s innovative drug products to patients in need. In this role, you will report directly to the Exec. Director, IT and be responsible to deliver on compliance and risk management for digital processes to achieve commercialization objectives at the site. You will work with lab & process automation, large corporate systems, small biotech systems, across all functions for the Indianapolis site(s). Additional responsibilities will include establishing and ensuring appropriate IT policies and processes while working with IT partners and specialty equipment manufacturers to achieve our technology and commercialization goals.
Key Responsibilities:
- Ensure complete understanding of corporate policies and procedures related to all aspects of computer system validation and applicable local processes and policies.
- Draft and review of Computer System Validation Protocols including Validation Masterplans, Design documents, Process and Instrumentation Drawings, IQ, OQ, protocols.
- Liaises with cross-functional SMEs in developing and promulgating the computer system validation methodology for radiopharma.
- Participates actively with other groups to analyze and address process deficiencies. Work collaboratively with peers within various departments and Quality groups.
- Provides validation subject matter expertise (SME) in the Digital Plant environment and contributes to multi-function teams, advises personnel on validation matters, and defends their work before regulatory agencies and auditors.
- Provides CSV expertise and guidance.
- Responsible for compliance with local and global SOPs during qualification.
- Audit and Operational readiness for site.
- Change Management during qualification and sustaining.
Education and Experience/Skills:
- Demonstrated success working in a high-performing, business results-driven environment.
- Bachelors in Engineering, IT, Science field or equivalent
- Minimum 10+ year’s relevant industry experience. Prior radiopharma experience is highly valued but not required.
- Demonstrated experience with IT Quality & Compliance applications and systems in a bio-tech manufacturing environment.
- Understanding of, and experience with, supply chain, manufacturing and quality domains and supporting technology including Manufacturing systems (MES), Quality systems (LIMS, QMS), Supply chain systems (ERP), Process Automation and Historians.
- Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.
- Knowledge of industry standard Quality and Compliance methodology to ensure our IT systems deliver the intended performance and ensure they meet regulatory requirements.
- Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, EudraLex Annex 11 and good documentation practices.
Please click here to apply.
