Senior Manager, IT Business Analyst – Development & Quality
About The Position
Kardigan is a heart health company dedicated to making cardiovascular disease preventable, curable, and no longer the leading cause of death globally. The company's mission is to develop multiple targeted treatments for cardiovascular diseases. Founded by Tassos Gianakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., who previously led MyoKardia, Kardigan boasts a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team. The company's values include being patient-driven, authentic, eager to learn, committed to winning as a team, and enabling the impossible to advance scientific discoveries. The Senior Manager, IT Business Analyst – Development & Quality will lead business analysis capabilities and act as a strategic technology partner to Clinical Development, Regulatory Affairs, Pharmacovigilance/Safety, and Quality organizations within a pharmaceutical company. This role is crucial for translating business needs into high-quality, compliant, and scalable technology solutions that support the entire drug development lifecycle in a GxP-regulated environment.
Requirements
- Bachelor’s degree in Information Systems, Life Sciences, Computer Science, or related field
- 7+ years of experience in IT Business Analysis or related roles
- 5+ years supporting Pharma or Life Sciences clinical, regulatory, safety, quality organizations
- Demonstrated experience operating in GxP‑regulated environments
- Strong collaboration skills with internal IT team and external partners
- Strong leadership and stakeholder management skills
- Expert‑level business analysis and requirements management capability
- Ability to operate at both strategic and execution levels
- Excellent written, verbal, and facilitation skills
- Project management skills leading complex enterprise-wide system implementations
- Strong familiarity with Development systems supporting Clinical Development, Regulatory, Pharmacovigilance / Safety, Quality
- Solid understanding of system integrations, data flows, and reporting architectures
- Experience working within validated system landscapes
- Strong working knowledge of GxP principles
- Strong working knowledge of 21 CFR Part 11
- Strong working knowledge of Data integrity and audit readiness
- Experience partnering with Quality and Validation teams
- Hands-on knowledge of Veeva-centric ecosystem including Veeva Vault Clinical, Vault RIM, Vault Safety, Vault Quality, and Veeva CRM
Responsibilities
- Lead and oversee business analysis activities across Development‑related initiatives, including Clinical, Regulatory, Safety and Quality programs
- Establish business analysis standards, methodologies, and best practices aligned with SDLC and validation requirements
- Create / Review key analysis artifacts to ensure clarity, completeness, and regulatory readiness
- Act as escalation point for complex requirements, scope decisions, and cross‑functional dependencies
- Serve as a trusted IT partner to leaders
- Develop a strong understanding of Development & Quality strategies and portfolio priorities, global regulatory expectations and submission timelines, and inspection and audit risk areas
- Partner with business stakeholders to shape demand into well‑defined, value‑driven initiatives
- Ensure alignment between Development & Quality priorities and IT roadmaps, architecture, and data strategies
- Lead end‑to‑end business analysis activities, including stakeholder interviews and facilitated workshops, AS‑IS / TO‑BE process mapping, gap, impact, and risk analysis
- Elicit, document, and manage business, functional, non‑functional, data, reporting, and integration requirements
- Produce and govern high‑quality deliverables such as Business Requirements, Functional Specifications, User Stories and Acceptance Criteria, Process flows and data models
- Ensure requirements are clear, testable, traceable, and compliant with GxP and validation standards
- Support Clinical Development systems clinical integrations, and analytics platforms to ensure data integrity, operational transparency, and inspection readiness
- Partner with Regulatory, Pharmacovigilance and Quality teams to support regulatory information management, submissions, safety case management, quality management systems and global reporting
- Identify and document use cases to leverage advanced technology solutions such as AI, to improve efficiencies in core business process
- Ensure all Development‑related IT solutions comply with GxP principles, 21 CFR Part 11 and Annex 11, and internal SOPs and validation standards
- Partner closely with Quality and Validation teams to support system impact assessments, validation planning and execution inputs, and Requirements Traceability Matrices
- Participate in audits and regulatory inspections as an IT representative
- Identify and proactively mitigate technology and data integrity risks
- Partner with Project Managers to support delivery execution
- Ensure requirements are effectively translated into design, build, and test activities
- Support UAT strategy, defect triage, and business sign‑off
- Drive business readiness activities including training, communications, and adoption planning
- Track and report on outcomes, benefits, and value realization
- Ensure post-project transition to support
- Ensure compliant configuration, integration, and data flow across Veeva platforms and adjacent clinical, regulatory, and safety systems
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
