Project Manager Consulting assignment within Pharma & Device CAPEX projects

Wequel; Uppsala kommun; On-site; SEK 700,000 - 1,000,000; Full time

Job summary

WeQuel seeks an experienced Project Manager in Uppsala to drive CAPEX projects from planning through execution to closure within the client’s Capital Portfolio Management function.

You will own projects end to end, collaborating with project teams to ensure regulatory compliance for pharmaceutical and medical device products, including facilities, manufacturing or QC laboratories.

Qualifications

• Extensive project management experience delivering CAPEX projects on time and within budget.
• Solid knowledge of pharmaceutical and medical device regulatory requirements (cGMP, MDR, ISO 13485, ISO 14971).
• Ability to work independently with strong ownership.

Responsibilities

• End-to-end management of assigned CAPEX projects, from planning to closure
• Feasibility studies and Steering Committee material
• Project execution in line with schedule, scope and budget
• Risk assessments, budgeting and project planning
• Continuous monitoring and progress follow-up
• URS authorship with support available
• Procurement and purchasing activities with support available
• Chairing project meetings and pulse meetings
• Monthly status reporting
• Ensuring regulatory compliance
• Handover of fully implemented, operational deliverables ready for use
• Take ownership of project flow and collaborate with stakeholders across the organization

Skills

Project management

CAPEX

Regulatory compliance

Vendor management

URS drafting

Job description

At WeQuel, we are now looking for a Project Manager in Uppsala, where you will play a key role in the client's Capital Portfolio Management function, focusing on driving several CAPEX projects from planning through execution to closure. You will own your projects end to end, working closely with the project team to make sure every project meets the client's standards and all applicable regulatory requirements for pharmaceutical and medical device products. Your projects may relate to facilities, manufacturing or Quality Control laboratories.

As a consultant with us, you will have the opportunity to work with one of our clients, leading companies within the pharmaceutical and medical device industries. There you will help bring new technology into operation, improve facilities and processes, and deliver sustainable, compliant solutions.

Your responsibilities:

• End-to-end management of assigned CAPEX projects, from planning to closure

• Evaluation of alternative execution solutions together with the project sponsor

• Feasibility studies and preparation of Steering Committee material

• Project execution in line with approved schedule, scope and budget

• Risk assessments, budgeting and project planning, carried out independently

• Continuous monitoring and follow-up of project progress

• Primary authorship of User Requirement Specifications (URS), with support available

• Procurement and purchasing activities, with support available

• Chairing project meetings and taking part in pulse meetings

• Monthly status reporting

• Ensuring compliance with the client's standards and regulatory requirements

• Handover of fully implemented, operational deliverables ready for use

You will take full ownership of your project flow and often work without a dedicated project team or with limited resources, while collaborating with a wide range of stakeholders across the organization.

Requirements:

• Extensive project management experience, with a proven ability to deliver on time and within budget

• Strong technical background (preferred)

• Solid knowledge of pharmaceutical and medical device requirements: cGMP, 21 CFR Part 11, GAMP 5, MDR, ISO 13485 and ISO 14971

• Strong sense of ownership

• Confident running every aspect of a project independently

Assignment details:

• Workload: 100%

• Remote: 100% onsite

We offer

At WeQuel, you become part of a consultant team that values people first. We believe success is created through engagement, collaboration and development. We offer a flat organization with short decision paths, a strong sense of community and the opportunity to influence your own development.