Validation Manager
The Position
Join Boehringer Ingelheim's IT Enterprise Data Platform (IT EDP) team as a Validation Manager and play a key role in ensuring that IT platforms supporting enterprise data and analytics capabilities operate within a compliant and controlled environment throughout their lifecycle. The role provides governance and oversight of validation and qualification activities, ensuring adherence to company quality standards and applicable regulatory requirements.
Working closely with IT, Quality, and business stakeholders, the Validation Manager helps maintain an inspection-ready environment while supporting the reliable operation of critical data platforms and services.
Duties & Responsibilities
In this role, you will
- Maintain and oversee the validation and qualification framework for Analytics Applications Platforms.
- Ensure platforms and supporting infrastructure remain in a qualified and compliant state throughout their lifecycle.
- Coordinate validation and qualification activities related to implementations, upgrades, enhancements, and lifecycle changes.
- Assess the impact of changes and support appropriate risk-based decisions.
- Partner with Quality Assurance and IT teams to support audits, inspections, and compliance assessments.
- Manage validation documentation and ensure compliance with internal quality standards.
- Identify, evaluate, and help mitigate compliance and operational risks.
- Drive continuous improvement of validation processes and practices.
- Act as a key point of contact for validation-related topics across stakeholders.
Requirements:
- Bachelor's degree in Information Technology, Computer Science, Engineering, Life Sciences, or a related discipline.
- Experience working in validation, quality, compliance, IT governance, or related functions within a regulated industry.
- Experience in pharmaceutical, biotechnology, medical devices, or other highly regulated environments. Familiarity with industry standards and regulations such as GxP, GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, and Data Integrity principles.
- Understanding quality systems, compliance requirements, and risk management principles.
- Experience supporting audits, inspections, or compliance reviews.
- Strong communication, organization, and stakeholder management skills.
- Ability to work effectively across cross-functional and global teams.
Nice-to-have Qualifications:
- Familiarity with data and analytics platforms used in regulated environments.
- Knowledge of Business Intelligence and Analytics solutions such as Tableau, Statistica, or similar platforms.
- Exposure to enterprise data platforms, reporting solutions, or data governance initiatives.
- Understanding of GxP-regulated processes and pharmaceutical industry practices.
Key Competencies:
- Compliance and quality mindset
- Risk awareness and sound judgment
- Attention to detail
- Problem solving and analytical thinking
- Collaboration and stakeholder engagement
- Planning and organizational skills
- Continuous improvement orientation.