Project Manager (Validation and Compliance)

at  Skillspark AB

START28-02-2025

DURATION7-9 months
emagine is seeking a Project Manager for a client in the Capital Region for a strategic enabler project running in our clients supply chain area to strengthen and streamline future order flows. The project is structured in supply chain area with several tracks in the project. As Workstream lead for the Test and Validation track you will have responsibility for this track and associated deliverables. Validation experience with SAP project is preferred. GxP experience is required.

JOB DESCRIPTION:

We are seeking a consultant, who can combine compliance expertise, validation methodology, project management skills, communication skills, and problem-solving skills. The consultant must ensure that the project organization is compliant with relevant regulations and standards, and that validation activities are performed in a consistent and compliant manner. The consultant should also be able to work collaboratively with others to identify and solve compliance and validation issues. Currently the project is in an upstart phase where requirements are still being defined. Until execution phase (Sep 25) the Validation Lead will be the only person in the Test and Validation track. We are seeking a profile that has project management skills, are self-driven and able to communicate plans and validation strategies to the team and management. It is important that you can both drive and execution tasks.

REQUIREMENTS:

• Experience in validation methodology, including developing and executing validation protocols, creating validation plans, and performing risk assessments
• Pharma industry knowledge is required with experience in implementation regulatory requirements (GAMP5) for IT systems and processes
• Experience in leading a Validation track in a project setup
• Strong communication skills
• Experience with SAP related projects preferred
• Well versed in project management methodology and principles
• Able to handle complexity and stakeholder management skills
• Able to author leading validation documentation and presentation
  Duration: Anticipated to be a long-term rolling contract
  Allocation: 60–100%
  Start date: As soon as possible
  Philip Møller Larsen
  Sourcing Specialist
  ppln@emagine.dk
  +455433002

• Defining and executing validation and qualification strategy for GxP end-to-end validation and qualification activities, including creating a validation plan, validation report, design review, test strategy, execution etc. The role is also responsible for performing assessments such as, IT risk assessment, IT requirements risk assessment, functional and data integrity assessments.
• Compliance expertise: Deep understanding of relevant regulations, standards, and guidelines. Ability to interpret and apply requirements to the organization and provide guidance to the project team on how to achieve compliance. Responsible for ensuring that systems are in compliance with relevant internal and external regulatory requirements. Ensure that the project documentation is inspection ready.
• Project management skills: Manage validation and compliance projects effectively. Proactively plan and track project tasks related to validation and ensure that tasks are delivered on time. Planning and coordination, ensuring the timely test planning and execution by Test Manager and timing for onboarding a Test Manager to the project.
• Communication skills: Excellent communication skills and be able to effectively communicate with stakeholders, team members, and management. Articulate compliance requirements and validation strategy and provide guidance on best practices.
• Problem-solving skills: Identify and solve problems related to compliance and validation. Anticipate and mitigate risks and provide guidance on corrective actions. Investigate and troubleshoot issues and develop solutions that address root causes.