Associate Director, Early Development Solutions, and IT GxP Compliance

Associate Director, Early Development Solutions, and IT GxP Compliance

Client:
Innovative Biopharma client

Contract/Perm & duration:
12-month contract (potential for extension)

Location:
Downtown Toronto, 2-3 days onsite per week

The Associate Director of Early Development Solutions and IT GxP Compliance , reporting to the Director of Early Development Solutions and Lab IT Services, will build strong relationships with key stakeholders across wet lab operations including Process Development, Analytical and Quality Control, MSAT, QC, Device Development and QA functions, delivering innovative and efficient IT solutions and services. The candidate will advise science teams in the areas of industry best practices for technology solution implementation to improve business process and operations, increase efficiency and effectiveness in the way scientists collect, store, analyze, process, and interpret data in compliance with industry expectations and regulations.

Additionally, the candidate, in partnership with the IT Risk Management and Compliance team, will oversee IT GxP compliance and data integrity technical control initiatives, managing the IT GxP Compliance portfolio, and driving projects through completion.

This position, in conjunction with the team lead, will be responsible for the building, deploying, managing and continuous improvement of critical technology initiatives including but not limited to, Electronic Lab Notebooks (ELN), Laboratory Information Systems (LIMS), Lab Execution Systems (LES) and Scientific Data Management Systems (SDMS), as well as for oversight of lab instrumentation/research scientific data management, lab process automation and Integration. This role will work collaboratively with teams of internal and external resources, driving a culture of compliance across data architecture, system engineering, dev/ops, business systems analysis, program and project leads and lab IT on solution discovery, delivery, on-going development (continuous improvement) and operational support while achieving positive results through innovation and close collaboration with the Scientific community.

Responsibilities:

• Build and maintain relationships with research scientists, manufacturing teams, and quality assurance personnel at our client's R&D and GMP facilities.
• Support the Early Development IT project portfolio from ideation to project completion and close out
• Provide internal oversight of data integrity activities currently managed by external vendors.
• Drive user engagement and system adoption following recent implementations.
• Support the Early Development scientific and manufacturing laboratory application portfolio, including but not limited to ELN, LIMS, SDM, Equipment & Environmental Monitoring, Computerized Maintenance Mgmt. Systems (CMMS), Building Mgmt. Systems (BMS).
• Excellent organizational and leadership skills; Outstanding communication and interpersonal abilities with proven problem-solving and troubleshooting skills.
• Ability to work independently and exercise judgment with excellent attention to detail and risk mitigatio
• Accountable for ensuring IT lab operations meet regulatory and internal compliance standards (e.g., GxP, data integrity, audit readiness).

Key Qualifications:

• BS/BA in life science, information technology, or relevant field, with minimum 7 years of IT engineering, solution or technical architecture and/or business experience in pharmaceutical, medical device, or biotechnology field.
• Extensive experience in collaborating with scientists, researchers, clinicians and other stakeholders across all levels and disciplines (research, bioinformatics, computation biology, and quality assurance).
• Prior experience in providing governance and oversite to the laboratory IT/computing environment.
• Proven ability to lead business/IT teams responsible for implementing, enhancing, and supporting R&D software tools/technology including Electronic Lab Notebooks (ELN), Laboratory Information Systems (LIMS), Lab Execution Systems (LES), and Scientific Data Management Systems (SDMS).
• R&D IT consulting experience, advising leadership and business teams on system selection, implementation best practices, and life cycle management.
• Proven experience leading application life cycle management best practices, ensuring regulatory compliance; support system validation/testing (GxP, SOX, Privacy, etc.).
• Knowledge of controlled computer system environments supporting corporate audit and or regulatory inspection readiness, data integrity controls.