GxP Data Integrity Project Lead
The GxP Data Integrity Project Lead is directly reporting to the Head of GxP Data Integrity and is responsible for improving the document management process so that it continuously meets the evolving requirements in terms of GxP Data Integrity.
Collaborating with the various global functions (Global QA, GMP Automation, GMP Internal Manuf., QC and Global IT etc.), and leveraging the experience from both the manufacturing site, clinical trial supply and supply chain, the GxP Data Integrity Project Lead will be responsible to lead the development and timely roll- out of a digital solution to manage critical GMDP forms at both global and local level driving for end-to-end digitalization of processes.
The Responsibilities
- Drive the integration plan of the Quality Systems and Processes, to ensure business continuity as well as compliance at any time.
- Drive the plan to implement the identified solution at global level.
- Assess any GxP Data Integrity risks related and ensure adequate mitigation plan are in place and followed-up on.
- Ensures project team maintains focus on quality and continuous delivery.
- Provides visibility into delivery targets, commitments, and progress.
- Collaborate with GxP areas and the organization to successfully identify and manage stakeholders and their expectations.
- Ensure appropriate communication and escalation of the progresses, risks, constraints and shifts of timelines if any.
- Drives the implementation of the integrated systems and processes encompassing the change management principles (ADKAR model, change management model, etc.)
- Utilizes team feedback and metrics (quality, delivery rate, etc.) to track progresses of the changes and identify critical areas (in terms of resources, risks, impact, etc.)
- Communicates with leaders across the organization on a regular basis to ensure transparency into delivery, risk, issues, etc.
- Provide additional Quality Support and/or Leadership to other Data Integrity-related topics as required (e.g., reconciliation, destruction, archiving, Quality System Monitoring Report, Corporate SOP Revision etc…).
- Author, Review, and/or approve as appropriate any SOP, Change Control, Deviations, Investigation, CAPAs associated to the activities in scope and Data Integrity topics.
- Support audit/inspections as required.
Skills and Knowledge Requirements
- Strong organizational skills
- Excellent time management
- Excellent communication skills, including verbal, written, and presentation development and delivery (English is a must).
- Ability to influence stakeholders/project teams on whom there is no direct authority.
- Analytical skills to be able to manage complex issues into more manageable individual tasks – Prioritization skills and stress management to cope up with the various issues that may occur – Ability to communicate on the issues with various level of the organization (from expert discussions to senior management update).
- Functions effectively with minimal supervision and in a proactive approach.
- Good teamwork and team player.
- Facilitator, influencer, motivator, and planner.
- Prior experience and understanding of project management principles.
- Ability to work in transversal and cross-functional teams.
- Sufficient level of Quality and/or Technical GxP background and to be able to evaluate complex project risks and issues accurately and objectively.
- Prior knowledge of systems such as Trackwise and Veeva is an asset.
Our Offer
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
