Senior Project Manager – Medical Devices / Pharmaceuticals

Capgemini • Salt Lake City, UT

103d

About The Position

We are seeking a highly organized and technically proficient Project Manager to lead a strategic supplier qualification and packaging initiative in partnership with life science companies and Capgemini. This role will oversee workflows aligned to Quality Management System (QMS), focusing on sterile packaging of medical equipment and pharmaceutical products. The ideal candidate will manage cross-functional teams, ensure regulatory compliance, and drive timely execution across supplier onboarding, testing, and lifecycle closure.

Requirements

• Bachelor’s degree in engineering, Life Sciences, or related field (Master’s preferred).
• 7+ years of experience in project management within medical devices or pharmaceutical packaging.
• Strong understanding of sterile packaging requirements and supplier qualification processes.
• Familiarity with ISO 13485, ISO 11607, FDA 21 CFR Part 820, and GMP standards.
• Experience working in hybrid environments and managing cross-functional global teams.
• PMP or similar certification preferred.
• Excellent communication, stakeholder management, and problem-solving skills.

Responsibilities

• Lead execution of supplier qualification workflows (administrative updates, DV, PV) based on change complexity.
• Manage packaging projects for sterile medical and pharma products, ensuring compliance with required standards.
• Coordinate with Capgemini technical teams and client's regulatory stakeholders to ensure alignment and governance.
• Oversee change control, risk assessments, testing protocols, and onboarding activities.
• Track project milestones, deliverables, and KPIs using outcome-based performance models.
• Facilitate supplier scouting, qualification, and lifecycle documentation.
• Ensure timely regulatory submissions and validation testing for high-complexity changes.
• Conduct regular stakeholder updates, risk reviews, and escalation management.

Benefits

• Flexible work
• Healthcare including dental, vision, mental health, and well-being programs
• Financial well-being programs such as 401(k) and Employee Share Ownership Plan
• Paid time off and paid holidays
• Paid parental leave
• Family building benefits like adoption assistance, surrogacy, and cryopreservation
• Social well-being benefits like subsidized back-up child/elder care and tutoring
• Mentoring, coaching and learning programs
• Employee Resource Groups
• Disaster Relief

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees