Validation & Compliance Lead, Analytics Platforms

Boehringer Ingelheim GmbH

Philippines

Hybrid

PHP 900,000 - 1,500,000

Full time

14 hours ago
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Job summary

Boehringer Ingelheim is seeking a Validation Manager to oversee the validation and qualification framework for Analytics Applications Platforms in a regulated environment. You will ensure platforms stay qualified and compliant throughout their lifecycle, coordinating activities for implementations, upgrades, and lifecycle changes.

Collaborating with IT, Quality, and business stakeholders, you will support audits and compliance assessments while driving continuous improvement and maintaining

Qualifications

  • Bachelor's degree in Information Technology, Computer Science, Engineering, Life Sciences, or a related discipline.
  • Experience 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 GxP, GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, 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.

Responsibilities

  • 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.

Skills

Communication skills
Organization skills
Stakeholder management
Cross-functional collaboration

Education

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

Tools

Tableau
Statistica

Job description

Boehringer Ingelheim is seeking a Validation Manager to oversee the validation and qualification framework for Analytics Applications Platforms in a regulated environment. You will ensure platforms stay qualified and compliant throughout their lifecycle, coordinating activities for implementations, upgrades, and lifecycle changes.

Collaborating with IT, Quality, and business stakeholders, you will support audits and compliance assessments while driving continuous improvement and maintaining

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