Data Integrity Lead - Life Sciences (Flanders)

ALTEN; Geel; Sur place; EUR 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Permanent contract

Company car

Meal vouchers

Recovery days

Insurance

Résumé du poste

ALTEN Belgium is seeking a Data Integrity Lead for the Geel site to drive local gap and risk assessments, develop master plans, and align with global teams. The role requires deep pharma data integrity expertise, familiarity with FDA/EMA guidelines, and strong project management and leadership capabilities.

You will collaborate with IT, Laboratory, R&D, and Equipment domains and report to senior management while contributing to strategic roadmaps and process improvements.

Qualifications

• Deep understanding and experience of data integrity in a pharma manufacturing environment.
• Deep understanding of both FDA and EMA requirements towards Data integrity, including hands on experience with risk-based approaches and creation of validation documents.
• Excellent project management skills, organizing, planning and coordination skills
• Strong interpersonal & communication skills
• Experience in leading teams in complex / dynamic environments
• Coaching, human change management and training skills
• Languages; English (must), Dutch (preferred)

Responsabilités

• Lead the ongoing local gap assessment, risk assessment, and management activities at the Geel site across multiple technical domains, each with its own methodologies and requirements, including IT, Laboratory, R&D, and Equipment.
• Consolidate progress and status updates and communicate them effectively to stakeholders, including senior management and global teams.
• Participate in global Data Integrity teams, representing the Geel site, ensuring local requirements are considered and effectively communicated.
• Develop, implement, and follow up on Data Integrity master plans and strategic roadmaps.
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Connaissances

Data integrity

FDA/EMA knowledge

Risk management

Project management

Stakeholder communication

Team leadership

Coaching & training

English language

Dutch preferred

Description du poste

ALTEN Belgium is a leading consultancy company in the fields of Life Sciences, Engineering and IT in which our people and clients are central.

In our open and adaptable organization, we get the best out of our ambitious employees enabling them to perform optimally. We do this by offering them the most challenging projects, but also to continuously acquire new expertise to boost their careers. This can be done with the help of our ALTEN Academy, but also through our knowledge sharing events.

All employees together form a large network of expertise, even at an international level. In this way we offer optimal growth to our consultants and the best solutions for our customers.

We are currently looking for a Data Integrity Lead at one of our clients.

Main responsibilities

• Lead the ongoing local gap assessment, risk assessment, and management activities at the Geel site across multiple technical domains, each with its own methodologies and requirements, including IT, Laboratory, R&D, and Equipment.
• Consolidate progress and status updates and communicate them effectively to stakeholders, including senior management and global teams.
• Participate in global Data Integrity teams, representing the Geel site, ensuring local requirements are considered and effectively communicated.
• Develop, implement, and follow up on Data Integrity master plans and strategic roadmaps.

Your profile

• Deep understanding and experience of data integrity in a pharma manufacturing environment
• Deep understanding of both FDA and EMA requirements towards Data integrity, including hands on experience with risk-based approaches and creation of validation documents.
• Excellent project management skills, organizing, planning and coordination skills
• Strong interpersonal & communication skills
• Experience in leading teams in complex / dynamic environments
• Coaching, human change management and training skills
• Languages; English (must), Dutch (preferred)

What ALTEN has to offer

• A permanent contract
• A salary package in line with your experience and extra benefits (company car, meal vouchers, recovery days, insurances)
• The possibility to join a great team and be part of the success story of an international group

We are looking forward to getting to know you and your ambitions!