Job description
MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health.
Founded in 2019, we are continuously expanding our presence and global footprint. We are constantly searching for high-impact individuals in various clinical, technical and business operations domains to strengthen our team of patient-centric, intelligent individuals.
Responsibilities:
- Define the overall validation strategy and approach for GxP-regulated computerized systems at MindMed
- Serve as the CSV SME during vendor evaluations, software implementation and qualification and requalification of GxP systems
- Partner with QA to develop and maintain risk-based Computer Systems Validation processes including establishment and/or refinement of policy, procedures, and work instructions
- Partner with System/Process Owners to implement and maintain GxP computerized systems in a validated state in compliance with regulations, internal policy and industry best practices
- Author key validation documents including Validation Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), User Acceptance Testing, Traceability Matrix, Validation Reports, Change Control Documentation, and Risk Assessment reports
- Advise project and technology teams on validation and data integrity best practices and approaches
- Coordinate with external Vendors on validation and system administration activities
- Serve as the Change Manager for all new releases and conduct risk assessments of proposed changes to computerized systems, working with System/Process Owners to assess risk and determine which elements should be validated
- Support systems and new product introduction by providing technical expertise, system administration, problem solving, and strategies for risk mitigation
- Partner with QA to ensure inspection readiness is maintained for CSV
- IT CSV operational support activities may include performing in the role of an IT project manager on small or medium-sized operational change activities
- Develop and maintain a CSV portfolio dashboard for timelines, resources, and operational efforts
Requirements:
- 7+ years experience working in the pharmaceutical/biotech space required
- 5+ years’ experience with CSV validation lifecycle management, validation documentation development in FDA regulated industry with a primary focus of GCP
- Bachelor’s degree in computer science, engineering life science or related field
- Excellent understanding of 21 CFR Part 11/Annex 11 compliance and Computer System Validation (CSV), Computer System Assurance (CSA), IT SLDC best practices, General Data Protection Regulation (GDPR) regulations, and GAMP 5 Guidance
- Proven experience in leading sustainable and nimble validation efforts for SaaS/PaaS GxP systems
- Broad understanding of Technology implementation (SaaS) and Data migrations approaches
- Proven track record managing software implementation and validation efforts
- Extensive hands-on work with Validating GxP platforms such as EDC, CTMS, QMS, SAS
- Demonstrated experience in authoring key validation deliverables such as user requirements, validation plans, validation reports and test scripts
- Experience with Veeva and Medidata R&D platforms is a major plus
- Excellent interpersonal, communication, organizational, and project management skills
The starting base pay range for this position is $141,391.00 - $174,836.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location.
Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:
- 100% paid health benefits including Medical, Dental and Vision for you and your dependents
- 401(k) program with company match and immediate vesting
- Flexible time off
- Generous parental leave and some fun fringe perks!
