Senior Project Manager – Medical Devices / Pharmaceuticals at Capgemini Portugal

Salt Lake City, Utah, United States -

Full Time

Start Date

Immediate

Expiry Date

22 Dec, 25

Salary

0.0

Posted On

23 Sep, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Project Management, Supplier Qualification, Sterile Packaging, Regulatory Compliance, Cross-Functional Team Management, Risk Assessment, Change Control, Stakeholder Management, Problem Solving, ISO Standards, GMP Standards, Communication, Lifecycle Documentation, Testing Protocols, Performance Tracking, Onboarding Activities

Industry

IT Services and IT Consulting

Description

Job Title: Project Manager – Supplier Qualification & Sterile Packaging Location: Salt Lake City, Utah (Hybrid: 3 days onsite / 2 days remote) Employment Type: Full-Time Industry: Medical Devices / Pharmaceuticals Function: Supply Chain, Quality, Regulatory, Packaging Engineering Role Summary: 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. Key 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. Qualifications: · 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. Life at Capgemini Capgemini supports all aspects of your well-being throughout the changing stages of your life and career. For eligible employees, we offer: 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 About Capgemini Engineering World leader in engineering and R&D services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds. Coupled with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has 65,000 engineer and scientist team members in over 30 countries across sectors including Aeronautics, Space, Defense, Naval, Automotive, Rail, Infrastructure & Transportation, Energy, Utilities & Chemicals, Life Sciences, Communications, Semiconductor & Electronics, Industrial & Consumer, Software & Internet. Capgemini Engineering is an integral part of the Capgemini Group, a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2024 global revenues of €22.1 billion. Get the future you want | www.capgemini.com Disclaimer Capgemini is an Equal Opportunity Employer encouraging inclusion in the workplace. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status or any other characteristic protected by law. This is a general description of the Duties, Responsibilities and Qualifications required for this position. Physical, mental, sensory or environmental demands may be referenced in an attempt to communicate the manner in which this position traditionally is performed. Whenever necessary to provide individuals with disabilities an equal employment opportunity, Capgemini will consider reasonable accommodations that might involve varying job requirements and/or changing the way this job is performed, provided that such accommodations do not pose an undue hardship. Capgemini is committed to providing reasonable accommodations during our recruitment process. If you need assistance or accommodation, please reach out to your recruiting contact. Please be aware that Capgemini may capture your image (video or screenshot) during the interview process and that image may be used for verification, including during the hiring and onboarding process. Click the following link for more information on your rights as an Applicant http://www.capgemini.com/resources/equal-employment-opportunity-is-the-law Applicants for employment in the US must have valid work authorization that does not now and/or will not in the future require sponsorship of a visa for employment authorization in the US by Capgemini.

Responsibilities

Lead the execution of supplier qualification workflows and manage packaging projects for sterile medical and pharmaceutical products. Ensure compliance with regulatory standards and oversee change control, risk assessments, and onboarding activities.