IT Project Manager - CSV & Compliance

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The Position

Job description

We are looking for a Project Manager / Scrum Master (CSV & Compliance) to drive the end-to-end delivery of validated computerized system implementations, upgrades, and migrations. In this hybrid role, you will balance traditional project management governance (scope, budget, timeline, and vendor oversight) and active Scrum Master facilitation with deep hands-on oversight of CSV/CSA lifecycles under GxP regulations. You will serve as the central bridge connecting business owners, technical engineering squads, and Quality Assurance, ensuring rapid iterative delivery without compromising regulatory compliance.

As a Delivery Management Professional, you independently manage less complex deliveries, solve problems within your scope, build stakeholder relationships, and begin to align your work with broader objectives while supporting team development. You will take ownership of clearly defined tasks, smaller projects, or initiatives, and contribute to larger project scopes, operating across the Project Manager and Scrum Master role archetypes.

Description of the area

This role sits within a delivery organization responsible for implementing, upgrading, and migrating GxP-regulated computerized systems. You will work with business owners, technical engineering squads, Quality Assurance, and external vendors to deliver validated solutions iteratively while maintaining audit and inspection readiness.

Job Responsibilities

• Scope / (Content Leadership): Takes ownership of clearly defined, less complex tasks, smaller projects, or initiatives within their area of responsibility, including validated system implementations, upgrades, and migrations. Assists in outlining and documenting the scope for larger projects, pinpointing key components (including validation scope and GxP impact), and starting to identify and flag potential scope-affecting issues. Supports and contributes to the management of minor scope changes, understanding their basic impact on delivery and validation status, and actively participates in scope-related discussions. Maintains and refines the product backlog so that validation and compliance activities are planned alongside functional work. Contributes to the definition of product roadmaps or service improvement plans upon request and supports team members in understanding a clear, manageable scope.
• Delivery Governance: Applies traditional project management governance to assigned initiatives, including planning, milestone tracking, risk and issue management, and status reporting. Provides day-to-day oversight of tracking deliverables, quality of work, and adherence to agreed timelines and quality requirements. Escalates deviations from scope or timeline early, with proposed options for resolution.
• Scrum Master Facilitation: Actively facilitates Scrum events (sprint planning, daily stand-ups, reviews, and retrospectives) for technical engineering squads. Coaches the team on Agile practices, removes impediments, and fosters a culture of continuous improvement. Adapts Agile ways of working to a regulated environment so that iterative delivery produces the documented evidence required for compliance (for example, embedding validation tasks and acceptance criteria into the definition of done).
• CSV/CSA Lifecycle Oversight (GxP Compliance): Provides hands-on oversight of Computer System Validation (CSV) and Computer Software Assurance (CSA) activities across the system lifecycle under GxP regulations. Coordinates the creation, review, and approval of validation deliverables such as validation plans, risk assessments, requirements and traceability matrices, test strategies and test summary reports, and validation summary reports.
• Accountability/Problem Solving: Independently analyzes less complex delivery and compliance problems within assigned areas, helping to identify root causes and eliciting stakeholder needs with less supervision. Owns problem-solving plans within scope, defines and presents solutions, and breaks down challenges. Applies independent analysis to identify discrepancies (including gaps in validation documentation or traceability), question assumptions, and propose improvements. Proactively reaches out for help when needed, supports team development, builds trust with product teams/peers, and contributes to discussions.
• Impact/Strategy: Contributes to projects or workgroups within a specified area and may participate, support, or lead moderate-size projects. Efforts directly support achieving targeted team or chapter-related outcomes. Identifies opportunities for minor process improvements within their immediate scope (for example, streamlining validation documentation or adopting risk-based CSA practices) and demonstrates growing autonomy and expertise. Supports planning and prioritization while aligning behaviors with the strategy of the organization.
• Complexity / (Product Size): Works on a product or larger context, managing small to medium-sized initiatives where the impact extends to a specific deliverable or feature. Handles moderately complex delivery tasks and requirements in a regulated environment, applies standard methodologies with some adaptation, and manages a moderate number of related deliverables. Interacts with stakeholders across the delivery team, QA, and vendors, managing stakeholders with moderate complexity.

Qualifications

Education / Experience

• Demonstrated experience in managing small to medium-sized initiatives, projects, or workstreams within a product or larger context, ideally in a GxP-regulated (e.g., pharmaceutical, biotech, healthcare, or life sciences) environment.
• Hands-on experience with CSV and/or CSA lifecycles for the implementation, upgrade, or migration of computerized systems, including coordination of validation deliverables with Quality Assurance.
• Experience acting as a Scrum Master or Agile delivery lead for technical engineering squads, and applying project management governance (scope, budget, timeline) alongside Agile practices.
• Experience overseeing vendors or implementation partners.
• Experience independently analyzing less complex delivery problems, identifying root causes, and owning problem-solving plans.
• Proven ability to build rapport with stakeholders, facilitate meetings, and manage stakeholder expectations within a defined area of responsibility.

Technical / Business Skills

• Working knowledge of GxP regulations and related guidance, data integrity principles, and risk-based validation approaches, including CSA.
• Understands the business context for their deliverables, contributes to defining how delivery aligns with business needs, and applies business knowledge to problem-solving.
• Applies standard delivery methodologies (e.g., Agile/Scrum, Waterfall, hybrid approaches, ITIL) with increasing proficiency, and can tailor them to meet regulatory requirements.
• Familiarity with change control, deviation/CAPA management, and requirements traceability practices.
• Capable of using a range of delivery tools and techniques (e.g., Jira, Confluence, and electronic quality or validation management systems) to manage delivery processes for small to medium-sized initiatives.
• Begins to identify business and process improvement opportunities within their immediate scope.

Additional Qualifications

• Strong communication and collaboration skills, with the ability to effectively build trust with product teams, QA, and peers.
• Demonstrates growing autonomy, supports planning and prioritization, and proactively reaches out for help when needed to address issues.
• Ability to balance rapid, iterative delivery with regulatory compliance and documentation rigor.
• Relevant certifications (e.g., CSM/PSM) are an advantage.

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Roche is an Equal Opportunity Employer.