AI Prototyping Platform System Lead

Boehringer Ingelheim Pharmaceuticals, Inc.; Muntinlupa; On-site; PHP 1,200,000 - 2,400,000; Full time

Job summary

Boehringer Ingelheim's IT Enterprise Data Platform (IT EDP) team seeks a Validation Manager to ensure IT platforms for analytics operate in a compliant environment throughout their lifecycle.

You will govern validation and qualification activities and align with quality standards and 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

Qualifications

• Bachelor's degree in a relevant IT or life sciences field.
• Experience in validation, quality, compliance, IT governance, or related functions in regulated environments.
• Familiarity with GxP, GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, and Data Integrity principles.
• Understanding of quality systems, compliance requirements, and risk management.
• Experience supporting audits, inspections, or compliance reviews.

Responsibilities

• Maintain and oversee the validation and qualification framework for Analytics Applications Platforms.
• Ensure platforms remain qualified and compliant throughout their lifecycle.
• Coordinate validation activities for implementations, upgrades, and lifecycle changes.
• Assess impact of changes and support risk-based decisions with QA and IT.
• Manage validation documentation and mitigate compliance and operational risks.
• Drive continuous improvement of validation processes.
• Serve as the main contact for validation topics across stakeholders.

Skills

Strong communication

Organization

Stakeholder management

Cross-functional collaboration

Education

Bachelor's degree in Information Technology, Computer Science, Engineering, Life Sciences, or related

Tools

Tableau

Statistica

Job description

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.

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

Our Company

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.

Why Boehringer Ingelheim?

With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.

Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Want to learn more? Visit https://www.boehringer-ingelheim.com