Associate Director, Laboratory Informatics & GxP IT Compliance

Who is BlueRock?BlueRock Therapeutics, a wholly owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases. The convergence of cell biology and genetic engineering is creating fundamental new ways to impact disease. Founded in 2016 to capitalize on these technological breakthroughs, we are advancing our novel cell+gene platform to develop, manufacture, and deliver an entirely new generation of authentic and engineered cell therapies across three therapeutic areas: neurology, cardiology, and immunology. Are We Doing?Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit. We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options. We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance innovative cellular therapies to impact patients’ lives. Description of Position:The Associate Director, Laboratory Informatics & GxP IT Compliance will foster strong relationships across wet lab operations at Toronto facilities and deliver efficient IT solutions supporting both GMP and non-GMP labs (process development, device development, analytical and quality control) including Scientific Data Management, Electronic Lab Notebooks, Laboratory Information/Execution Systems. This role advises science teams on best practices for technology implementation and IT change management to streamline data processes and ensure regulatory compliance. The ideal candidate will also oversee IT GxP compliance and data integrity controls, from initial risk assessment to remediation plans, effectiveness checks, and periodic review. Responsibilities also include overseeing the project portfolio and coordinating external resources and service providers, in collaboration with business and system owners, Quality Assurance, and IT Leadership.

Responsibilities

• Build and maintain relationships with scientists, manufacturing teams, and quality assurance personnel at BlueRock’s Toronto R&D and GMP facilities.
• Accountable for ensuring Laboratory IT operations meet regulatory and internal compliance standards (, GxP, data integrity, audit readiness).
• Support the Early Development IT project portfolio from ideation to solution delivery and ongoing service, support.
• Provide internal oversight of data integrity activities currently managed by external vendors including risk assessments, computer system validation/assurance.
• 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).
• Drive user engagement and solution adoption and feedback post implementations.
• 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 mitigation.

Minimum Requirements

• 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).
• Proven experience leading application life cycle management best practices, ensuring regulatory compliance; support system validation/testing (GxP, SOX, Privacy, etc.).
• 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.
• Knowledge of controlled computer system environments supporting corporate audit and or regulatory inspection readiness, data integrity controls.
• Target Base Salary: $172,000-$203,000/CAD per year + bonus

$172,000 - $203,300 a year#LI-AL1We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.