Senior GMP Applications Administrator

POSITION SUMMARY

The Senior GMP Applications Administrator serves as a key technical partner supporting the reliable and compliant use of critical business and laboratory systems within a regulated biopharmaceutical manufacturing environment. This role combines strong application and database expertise with an understanding of cGMP operations, data integrity, and computerized system requirements. Working across IT, Quality, Manufacturing, Engineering, Validation, and external partners, the position helps ensure technology solutions effectively support business needs, regulatory expectations, and ongoing operational improvement.

PRIMARY RESPONSIBILITIES

• Administers, maintains, supports, and optimizes enterprise and laboratory applications, including Maximo, NuGenesis, MODA, and Empower.
• Serves as a technical subject matter expert and primary IT resource for assigned applications.
• Monitors application performance, availability, integrations, system health, and proactively address potential issues.
• Supports requests for enhancements, reports, configuration changes, patches, data migrations, and system implementations.
• Troubleshoots application, database, interface, configuration, and user-access issues in partnership with internal teams and external vendors.
• Plans and executes system upgrades while minimizing operational disruption and maintaining validated system status.
• Supports database administration activities, including queries, troubleshooting, system interfaces, backups, and data integrity.
• Ensures the integrity, security, availability, and appropriate access control of regulated application data.
• Partners with Quality and Validation teams to support computer system validation and lifecycle management activities.
• Develops, revises, reviews, and maintains application-related SOPs, work instructions, system documentation, configuration documentation, and technical procedures.
• Participates in change controls and other quality-system activities associated with computerized systems.
• Ensures assigned systems are maintained in accordance with cGMP, data-integrity principles, company policies, and applicable regulatory requirements.
• Collaborates with laboratory, manufacturing, engineering, quality, and business users to understand system requirements and recommend technical solutions.
• Coordinates with software vendors and service providers to resolve issues, implement enhancements, and support application lifecycle activities.
• Leads or supports IT projects from requirements gathering and system design through implementation, validation, deployment, and ongoing support.
• Identifies opportunities to improve application performance, reliability, usability, and business processes.
• Maintains accurate application inventories, system configurations, access documentation, and lifecycle records.
• Provides technical guidance and training to end users and other IT team members as needed. Works independently while effectively managing multiple priorities in a fast-paced regulated environment. Resolves stalled issues by ensuring timely issue escalation to Leadership and cross-functional teams: Applies learning from these events and leads the creation of new/updated systems, processes, programs to prevent similar situations in the future.
• Through self-education and external networking/participation in industry and professional organizations keeps abreast of current industry trends, compliance requirements, and best-of-class technologies relating to area of responsibility. Actively applies learned best practices, knowledge, and benchmarking to PTx projects and solutions.
• Pursues participation or leads project teams outside normal course of work (i.e. “collateral duties”) as they become available to support personal growth, connection, and business needs.
• Adheres to all applicable regulations and requirements including compliance with internal SOPs, regulatory requirements, company policies, and employment-related laws and statutes.
• Successfully completes all mandatory Compliance and Quality training within required timeframes.

KNOWLEDGE, SKILLS, ABILITIES

Required:

• Strong knowledge of enterprise and laboratory application administration in cGMP-regulated pharmaceutical, biotechnology, or similar environments.
• Hands-on experience supporting one or more of the following systems: Maximo, NuGenesis, MODA, or Empower.
• Experience supporting application installations, configurations, patches, upgrades, migrations, and enhancements.
• Knowledge of computer system validation (CSV) and application lifecycle management principles.
• Understanding of data integrity, security, user-access management, audit trails, and electronic records requirements.
• Working knowledge of relational databases and core database concepts.
• Experience developing, revising, and following Standard Operation Procedures and controlled documentation processes.
• Strong critical thinking, analytical, and problem-solving skills, with a proven ability to develop practical solutions that move the organization forward.
• Resourceful, with a proven ability to build and use a broad network of internal stakeholders, team members, and external resources to plan work and resolve issues. Strong relationship-management and interpersonal skills, with the ability to quickly earn the trust and confidence of others.
• Solid organizational and prioritization skills, with the ability to manage competing demands and deliver high-quality work on time and within budget.
• Biased toward action, adaptable, and composed when facing unexpected changes and challenges. Maintains a constructive attitude, gives and receives feedback openly, and works effectively within diverse teams and across functions.
• Excellent written and verbal English communication skills. Confident sharing opinions, asking questions, and participating actively in cross-functional meetings. Skilled at drafting clear, original communications, adjusting tone, content, and format to suit the audience and purpose.
• Proficient in Microsoft Office, particularly Word and Excel, with the ability and willingness to quickly learn new job-specific applications.

Preferred:

• Software application experience with Smartsheet, MS Project, and SharePoint.
• Project management experience or formal training (PMP, PMI) is a plus.

EXPERIENCE & EDUCATION

Required:

• Bachelor's degree in Information Technology, Computer Science, Information Systems or a general degree with equivalent relevant experience in the field.
• 8+ years of progressively responsible, relevant experience supporting applications and database system as an administrator or in a similar role.
• Experience administering and supporting enterprise or laboratory applications.
• Experience working with databases and application integrations.

Preferred:

• Experience within a biotechnology, pharmaceutical, or cGMP manufacturing environment.
• Direct experience administering Maximo, NuGenesis, MODA, and/or Empower.
• Experience supporting validated GxP computerized systems.
• Knowledge of 21 CFR Part 11, data integrity principles, and computer system validation practices.

PTx is committed to the principles of competitive and pay equity for all of our Partners. The current pay range for this position is $120,000 - $145,000: Offers are made within the base pay range applicable at the time. Your salary will vary depending on several factors including your qualifications and experience.

In addition to medical, dental, vision, FSA/DCA, HRA, disability, and life insurance coverage, all full-time, regular Partners enjoy a casual Hybrid or Remote workplace program for many roles. We also offer a highly competitive compensation and benefits package, including an annual discretionary cash bonus and a 401(k) matching program. Partners in the Seattle area can take advantage of a free ORCA pass, and we also provide tuition and continuing education assistance to support ongoing professional development. Recognition for outstanding contributions and achievements is a core part of our culture.

Partner Therapeutics is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, age, national origin, veteran status, marital status, sexual orientation, gender identity, disability or any other category prohibited by local, state, or federal law. This policy applies to all aspects of employment, including recruitment, placement, promotion, transfer, demotion, compensation, benefits, social and recreational activities, and termination.

Originally posted on Himalayas