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CTMC · 3 weeks ago

Sr. Manager, Digital GxP Systems

Houston, TX

Full-time

Onsite

Senior Level, Lead/Staff

12+ years exp

CTMC is a pioneering biotech joint venture focused on accelerating cell therapies from bench to bedside. The Sr. Manager, Digital GxP Systems will develop standard approaches for LIMs and MES solutions, ensuring compliance with regulations and industry standards while collaborating with teams to enhance operational excellence.

BiopharmaBiotechnologyTherapeutics

H1B Sponsor Likely

Hiring Manager

Jenifer Klemme

Responsibilities

Develop and integrate LIMs and MES common and site-specific components

Benchmark on innovative solutions (external and internal to CTMC)

Dynamically adapt road map to site evolution/strategic directions, and new trends/issues

Establish a strong site culture based in CTMC values, expectations, and operational excellence standards

Support LIMs / MES solutions deployment and start up activities

Serve as System owner for LIMs and MES systems

Work with site resources towards replication & standardization to drive value and implement the appropriate technical solutions

Evaluate emerging technologies and implications to existing CTMC Digital systems

Maintain open communication with MES / LIMs vendor(s) to address needs in standard solutions or via functional packs

Evaluate and translate functional requirements into technical solutions

Ensure project and/or validation documentation is maintained during lifecycle & release management

Develop \ assist in the creation and maintenance of the LIMs and MES interfaces with other Digital systems

Provide guidance and direct activities to ensure manufacturing facility and support areas comply to applicable regulations and industry best standards

Lead and participate in projects within the organization’s objectives and project timelines and participate in cross-functional projects as the quality subject matter expert

Collaborate with other leaders across the organization and assist in the continuous improvement

The role is responsible for system design, implementation, and lifecycle management of LIMs and MES systems

Provide leadership or support in the implementation of LIMS and MES systems, drawing on prior experience with LabVantage and other LIMS platforms, as well as commercial EBS solutions such as MES

Collaborate with key stakeholders to capture business requirements and translate them into functional specifications

Oversee or prepare system design documentation, including URS, FRS, DS, configuration specifications, and data flow diagrams

Provide technical guidance on master data setup, workflows, system configuration, and reporting functions

Prepare, review, and approve GMP documentation (e.g., Non-Conformances, Procedures, Protocols, Specifications, and Change Controls) to ensure quality and user requirements are met

Participate in computer system validation (CSV), computer software assurance (CSA), and qualification activities according to GAMP 5 and 21 CFR Part 11

Maintain validation status and support periodic reviews and change management processes

Ensure data integrity and regulatory compliance throughout the system lifecycle

Conduct investigations and impact assessments for deviations, audit findings, and system issues related to electronic systems

Support internal and external audits and inspections by regulatory authorities such as the FDA

Train and mentor users and administrators on system functionality and compliance requirements

Work with vendors and IT teams to facilitate system upgrades and support structures

Remain informed about industry trends and emerging technologies in digital quality systems

Other duties as required

Qualification

LIMS implementationMES implementationGxP experiencePharmaceutical complianceCloud solutions knowledgeAnalytical thinkingMicrosoft Office proficiencyTeam leadershipProblem-solvingCommunication skillsTime management

Required

Bachelor's Degree in IT, Engineering, or related technical field

12+ years of GxP experience in Pharmaceutical Industry or equivalent combination of education and experience

5+ years of strong experience with LIMS and MES system implementations

Professional experience working in a GXP, regulated environment

Pharmaceutical Manufacturing Regulatory compliance knowledge and experience (cGMP)

Effective people and team leadership skills

Ability to manage and contribute to multiple concurrent activities and adapt to changes in priorities

Ability to cross functionally collaborate

Excellent written and oral communication skills

Demonstrate creativity, analytical thinking, and the ability to troubleshoot and solve problems

Knowledge of cloud solutions and architecture

History of promoting safety and maintaining a safe work environment

Demonstrated adherence to compliance for internal and external quality guidance

Demonstrate and promote Operational Excellence

Effectively encourage knowledge sharing and education

Evaluate and translate functional requirements into technical solutions

Proven technical ability to develop and integrate MES and LIMs solutions

Excellent time management skills with a proven ability to meet deadlines

Strong analytical and problem-solving skills

Proficient with Microsoft Office Suite or related software

Company

CTMC

CTMC is a clinical cancer center to enable innovation from academia and biotech to accelerate cell therapy’s impact on cancer patients.

Founded in 2022

Houston, Texas, USA

51-200 employees

https://ctmc.com

H1B Sponsorship

CTMC has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (2)

2022 (1)