GMP IT Infrastructure and System Manager

Job Description

Job Description

AbelZeta Inc. is a clinical stage biopharmaceutical company focused on the development of novel immunotherapy products. AbelZeta operates a state-of-the-art facility in Rockville, Maryland with five GMP rooms and a QC laboratory in order to augment its global research and development capabilities and to support clinical development of multiple cell therapy platform technologies. We are on a rapid growth trajectory and have a highly energized and accomplished team driving to new frontiers of care for cancer and autoimmune disease patients.

We are seeking a GMP IT Infrastructure and System Manager / Sr. Manager to join our team. He or she will play a pivotal role in establishing and maintaining GMP Computer System, Data Integrity and Compliance and network security procedures. This role will be also responsible for managing the day-to-day IT operations activities.

Responsibilities and Duties :

• Design, implement, and maintain GMP IT system infrastructure.
• Coordinate with IT vendor to manage and maintain essential IT operation activities.
• Recommend and implement appropriate hardware and software Manage system security including data integrity and back-up management. Configure and enforce user access control procedure to prevent unauthorized access, changes, and deletion of data, or changes to validated settings.
• Work with internal partners to understand strategy and business challenges to proactively recommend IT solutions and to deliver key programs and projects for the site.
• Work with internal partners to implement IT changes
• Ensure compliance of company IT operations with the regulations and standards including but not limited to data security.
• Provide IT support for computer system validation (CSV) to ensure data integrity per FDA 21CFR part 11, EU GMP Annex 11, and GAMP5, etc.
• Establish robust data management system for archiving and accessing archived data.
• IT suppliers management : overseeing the selection and onboarding of IT suppliers, monitoring performance metrics and cost, etc
• IT fix assets management : tracking inventory of hardware, software, and network components and optimizing asset utilization to reduce costs and prevent redundancy, etc.
• Other duties as assigned.

Qualifications and Requirements :

Why You Should Join AbelZeta

AbelZeta is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. AbelZeta validates right to work using E-Verify. Salary at AbelZeta is determined by various factors, including but not limited to location, the individual’s particular combination of education, knowledge, skills, competencies, and experience, as well as contract-specific affordability and organizational requirements. The estimate displayed represents the typical salary range for this position and is just one component of AbelZeta’s total compensation package for employees.