PM Solutions / PM College · 1 day ago
Project Manager SDLC in Regulated Industry
North Chicago, IL
Full-time
Hybrid
Senior Level, Lead/Staff
$68/hr - $75/hr
8+ years expPM Solutions is seeking an exceptional Senior Project Manager for an onsite role in North Chicago. This role is responsible for driving the execution of technology and compliance initiatives, leading the delivery of regulated software initiatives while ensuring adherence to global regulatory standards across the SDLC.
Asset ManagementConsultingEducation
No H1B
Responsibilities
Participate in quarterly planning, dependency mapping, capacity coordination, and sprint-level execution cycles
Maintain project transparency through dashboards, Jira structures, and standard reporting artifacts
Support Product Managers with prioritization discussions, backlog refinement, scope clarification, and delivery sequencing
Adhere to governance standards, including checkpoints, retrospectives, risk reviews, and cross-team alignment forums
Manage the end-to-end lifecycle of compliance and regulatory initiatives, ensuring full traceability from requirements through validation, deployment, and closure
Ensure project activities comply with global regulatory standards and frameworks (FDA, EMA, GxP, GDPR, SOX, etc.) and internal controls
Partner with Legal, Quality, Privacy, and Regulatory Affairs to interpret evolving regulatory guidance and incorporate required changes into roadmaps and delivery plans
Identify compliance and delivery risks, develop mitigation and remediation plans, and escalate appropriately through appropriate governance channels
Work closely with Product Managers, Technical Leads, Architects, and Engineering teams to ensure regulatory initiatives are technically sound and delivered on time
Facilitate collaboration across IT, Legal, Finance, Quality, and Operations in alignment with client’s cross-team engagement model
Lead change management, communications, and training efforts in alignment with adoption and rollout standards
Support operational readiness activities including system validation, documentation, release management, and deployment coordination
Contribute to process standardization and policy harmonization efforts supporting the simplification and continuous improvement goals
Qualification
Required
Bachelor's degree in business, Information Technology, Regulatory Affairs, or a related field required
8+ years of project management experience in highly regulated environments (pharmaceutical, biotech, healthcare, or life sciences)
Proven experience managing compliance and regulatory initiatives within the SDLC
Strong understanding of validated software delivery, SDLC compliance requirements, and regulatory expectations
Experience partnering with compliance, quality, and regulatory teams to define requirements, implement controls, and track adherence
Ability to drive workstream objectives, execution, and measurable outcomes without being a hands-on technical contributor
Demonstrated strength in working with business stakeholders and cross-functional leadership
Strong capabilities in risk management, regulatory interpretation, and structured delivery governance
Proficiency with project management and collaboration tools including Jira, Confluence, MS Project, and reporting solutions
Ability to influence and collaborate across complex, matrixed organizations
Excellent written and verbal communication skills with a strong focus on transparency, documentation, and executive engagement
Preferred
Master's degree preferred
Experience working within product-aligned, Agile, or hybrid delivery frameworks preferred
Prior experience in large enterprise environments strongly preferred; Bio-Pharma or Life Sciences experience required
Background in software development process improvement and compliance validation strongly preferred
PMP or Agile certifications (PMI-ACP, SAFe, or equivalent)
Experience supporting system validations, audit readiness, and multi-country regulatory initiatives
Understanding of IT governance, data protection, privacy regulations, and enterprise compliance frameworks
Familiarity with Jira governance standards, and enterprise portfolio management processes
Benefits
401(k)
Health insurance
Referral program
Company
PM Solutions / PM College
PM Solutions is a project management solutions and consulting firm that helps PMO, project, and business leaders apply project and portfolio management process practices that drive performance and operational efficiency.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Kent Crawford
Founder & CEO
Dawn Swope
Chief Financial Officer
Company data provided by crunchbase