GxP IT Infrastructure and System Manager/Sr. Manager - Bilingual

Job Title: GxP IT Infrastructure and System Manager/Sr. Manager - Bilingual

Position Type: Full time

Location: Rockville, MD

Salary Rate: $90,000 - $110,000 annual base

Job Summary:
We are a clinical-stage biopharmaceutical company focused on developing novel immunotherapy products. We operate a state-of-the-art facility in Rockville, Maryland, with five GMP rooms to enhance its global research and development capabilities and support the clinical development of multiple cell therapy platform technologies in the U.S. The company is on a rapid growth trajectory, with a highly energized and accomplished team driving new frontiers of care for cancer and autoimmune disease patients.

We are seeking a GxP IT Infrastructure and System Manager/Sr. Manager to join our team. This role will play a pivotal part in establishing and maintaining data integrity, network security procedures for computer systems, and ensuring consistent system performance. The role will also involve overseeing day-to-day IT operations.

Responsibilities and Duties:

• Manage and maintain essential IT operations, including operating systems, security tools, applications, servers, email systems, laptops, desktops, software, and hardware.
• Oversee and determine timeframes for major IT projects, including system updates, upgrades, migrations, and outages.
• Work with internal teams to understand strategy and business challenges, proactively recommending IT solutions to support key programs and projects (e.g., ERP, LIMS).
• Develop and implement IT policies and best practice guides for the organization.
• Ensure all computerized systems are controlled and managed according to GxP, GDP, and SOX requirements.
• Safeguard systems against accidental or deliberate manipulation, modification, or other activities that could impact data quality and integrity.
• Maintain the inventory of all computerized systems.
• Keep an updated list of normal and administrative users, with clearly defined roles and privileges.
• Ensure audit trails or system logs for critical systems are maintained.
• Establish data storage and backup procedures.
• Set up disaster recovery procedures.
• Establish data archiving procedures, including access and retrieval of archived data.
• Perform periodic reviews of computer systems, including deviations, changes, upgrade history, performance, and maintenance.
• Upgrade operating systems and network components in a timely manner, including applying security patches.
• Ensure data is securely transferred or migrated to a validated location or database.
• Maintain system security, configure, and enforce user access control procedures to prevent unauthorized access, changes to data, or deletion of data.
• Establish proper storage device usage procedures for GMP purposes (e.g., USB memory sticks, server/cloud-based storage).
• Implement audit trail procedures on computer systems using a risk-based approach.
• Manage daily IT activities.
• Perform other duties as assigned.

Qualifications and Requirements:

• Bachelor's degree in technology or computer science.
• At least 5 years of relevant experience driving process improvements, implementing systems, and leading projects from design through implementation.
• Experience in biotech, pharma, or life sciences manufacturing and lab environments, with an understanding of GMP requirements.
• Expertise in implementing, configuring, and testing IT solutions.
• Proficiency in both English and Chinese is required for communication with both local and international teams.

Why You Should Join Us:

• Join a high-growth and fast-paced organization.
• Defined career path with annual performance reviews and feedback processes.
• Comprehensive benefits package, including 100% company-paid medical, dental, vision, life insurance, short-term and long-term disability insurance, and more.
• Competitive 401k match.
• Paid holidays, sick leave, and annual leave.