Computer System Validation Manager Jobs in Illinois

We are seeking a strategic and execution-focused Product Lead to join our team and drive the development of a new digital platform being built for a highly regulated industry. This individual will be responsible for defining and managing the product roadmap, translating business needs into actionable requirements, and coordinating across internal stakeholders and external development partners to ensure successful delivery.

This role will report directly into executive leadership and will serve as the central point of accountability for product definition, scope decisions, and cross-functional alignment. The ideal candidate will bring a strong background in digital product development, experience working in or with the pharmaceutical or life sciences industry, and a proven ability to lead complex, multi-stakeholder initiatives in regulated environments.

What you will do

• Own and manage the product roadmap, ensuring alignment with business objectives, regulatory requirements, and technical feasibility.
• Translate business needs, user feedback, and operational insights into clear, actionable product requirements and user stories.
• Serve as the primary liaison between internal stakeholders and external development partners, ensuring clarity of scope, priorities, and timelines.
• Lead scope definition and trade-off decisions, balancing speed, quality, compliance, and business value.
• Coordinate and facilitate cross-functional collaboration across engineering, quality, compliance, and operations teams.
• Ensure that product features and workflows are designed with regulatory compliance (e.g., GxP, FDA 21 CFR Part 11) in mind from the outset.
• Participate in sprint planning, backlog grooming, and product reviews with external development teams.
• Track and communicate progress, risks, and decisions to executive stakeholders.
• Support validation planning and documentation efforts in collaboration with quality and compliance leads.
• Champion a user-centered approach to product development, ensuring that the platform meets the needs of its intended users in regulated environments.

Qualifications:

• 8 years of experience in product management or product leadership roles, with a focus on digital platforms or enterprise software.
• Bachelor's or Master's degree in a relevant field (e.g., Engineering, Life Sciences, Computer Science, or Business).
• Experience working in or with regulated industries, ideally pharmaceutical, biotech, or medical devices.
• Proven ability to lead cross-functional product development efforts involving external partners or distributed teams.
• Strong understanding of software development processes (Agile, Scrum) and experience working closely with engineering teams.
• Excellent communication and stakeholder management skills, with the ability to translate between business, technical, and compliance domains.
• Demonstrated ability to make informed trade-off decisions and manage competing priorities.

• No immigration sponsorship is available for this roleat this time.

Preferred Qualifications:

• Familiarity with GxP, FDA 21 CFR Part 11, and Computer System Validation (CSV) principles.
• Experience with cloud-native platforms (Azure preferred; AWS or GCP also valued).
• Exposure to AI/ML-enabled products or edge computing architectures is a plus.

Benefits

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Potential Customer Requirements Notice

To meet customer requirements and comply with local or state regulations, applicants for certain customer-facing roles may need to:

- Undergo additional background screens and/or drug/alcohol testing for customer credentialing.

Americans with Disabilities Act (ADA)

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