The Product Manager will lead digital product initiatives, manage product lifecycle, align business and customer outcomes, and ensure compliance with regulations.
Are You Ready?
CAI is a 100% employee-owned professional services company established in 1996 that has grown year over year to nearly 850 people worldwide. For mission critical and FDA-regulated industries that need to deliver high-stakes solutions, we provide commissioning, qualification, validation, start-up, project management, and consulting services focused on operational readiness and performance excellence.
Our approach is simple because our Purpose informs everything we do:
We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.
At CAI, we are committed to living our Foundational Principles, both professionally and personally:
- We act with integrity
- We serve each other
- We serve society
- We work for our future
As owners, our shared success drives our team-first approach. We put clients’ interests first, never stop until it's right, and do whatever it takes to get there.
CAI agents work with cutting-edge technologies in advanced medicine and regulated facilities. You will have opportunities to engage with leading experts, participate in hands-on certifications, and make a direct impact by helping bring life-saving therapies to market. Our collaborative, values-driven culture ensures delivery of excellence across all services.
Job Summary:
We are seeking an experienced and execution-focused Product Manager to serve as the owner of CAI’s expanding toolkit of digital products and services. In this role, you will drive innovation, alignment, and delivery of configurable, scalable, and compliant digital solutions that support operational readiness and operational excellence in regulated industries. You will own the full product lifecycle, act as Product Owner within Agile teams, and ensure successful delivery from intake through launch and continuous improvement.
Key Responsibilities:
1. Project & Delivery Leadership
Own and drive end-to-end execution of digital product initiatives from intake through launch, ensuring delivery aligns with business and customer outcomes.
Lead planning, scheduling, and coordination across cross-functional teams, managing dependencies, milestones, and deliverables.
Develop and maintain delivery artifacts including delivery plans, RAID logs, milestone tracking, and action registers.
Proactively identify risks, escalate issues as needed, and drive mitigation strategies to protect delivery commitments.
Serve as the central owner for execution, ensuring work progresses efficiently and priorities remain aligned.
2. Product Strategy & Portfolio Management
Define and evolve the vision, strategy, and roadmap for CAI’s digital toolkit in alignment with business objectives and customer needs.
Prioritize and manage a product backlog spanning multiple digital products and service components.
Own the full product lifecycle from concept through deployment and continuous improvement, ensuring delivery of measurable business value.
3. Agile Product Ownership & Execution
Act as Scrum Product Owner across one or more Agile teams, maintaining delivery momentum and achieving sprint goals.
Translate business needs into clear epics, features, and user stories with defined acceptance criteria.
Lead backlog refinement, sprint planning, reviews, and retrospectives in partnership with Scrum teams.
Make real-time trade-off decisions to balance scope, risk, schedule, and value.
Monitor sprint progress and velocity, adjusting plans as capacity or priorities change.
4. Stakeholder Management & Cross-Functional Collaboration
Facilitate alignment and decision-making across operations, subject matter experts, regulatory advisors, technology partners, customer success, and leadership.
Coordinate internal and external contributors to ensure deliverables are reviewed, approved, and implemented on schedule.
Partner with marketing, sales, and delivery teams to support messaging, training, onboarding, and rollout activities.
Communicate status updates, risks, and key decisions with clarity and consistency.
5. Customer-Centric Requirements & Compliance Delivery
Gather, refine, validate, and manage requirements from internal and external stakeholders.
Drive customer feedback loops and iterative MVP delivery while maintaining scope and delivery discipline.
Ensure solutions align with global regulatory expectations including 21 CFR Part 11, GAMP 5, GxP, and ISO 27001, with appropriate validation rigor and documentation.
6. Solution Development, Scalability & Performance Optimization
Lead development and configuration of reusable templates, workflows, and components to accelerate client time-to-value.
Drive standardization and harmonization across digital products to support scalable, multi-site and global deployments.
Track delivery, adoption, and performance metrics (cycle time, ROI, usage, quality outcomes) and use insights to continuously improve solutions and execution.
Qualifications:
Required:
5+ years of experience in product management, digital transformation, or software delivery within life sciences or highly regulated environments.
2+ years of experience as a Scrum Product Owner or equivalent Agile delivery role.
Experience with digital validation, quality systems, or operational technology platforms (e.g., Kneat Gx, Veeva, TrackWise).
Strong understanding of GxP, data integrity, and CSV principles.
Excellent stakeholder management, communication, and prioritization skills.
Preferred:
Certified Scrum Product Owner (CSPO), Scrum Master, or equivalent certification.
Experience with configurable SaaS platforms, productized services, or reusable digital toolkits.
Familiarity with validation-related business processes including commissioning, qualification, change control, and quality risk management.
#LI-MV1
We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society.
This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).
Top Skills
Agile
Fda Regulations
Gxp
Iso 27001
Kneat Gx
SaaS
Scrum
Trackwise
Veeva
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