For our headquarters in Munich we are seeking highly qualified candidates to fill the position:

Director (m/f/d) E-Compliance / IT Governance 

The Position:

Reporting to the Head (m/f/d) of E-Compliance / IT Governance, you will lead the Regional/Local E-Compliance team, playing a key role in IT and Data Governance for Global QA systems. As Data Steward for core systems (ALTOS, eQMS, QualityDocs, VLM), you will ensure alignment with Daiichi Sankyo’s DX Data Governance. You will manage the IT QA portfolio, oversee GxP projects, and drive Computerized Systems Validation (CSV) compliance by defining risk-based validation strategies and providing operational oversight of GxP-related IT systems globally.

Roles and Responsibilities:

Strategy Deployment

• Lead global principles and strategies for CSV, IT governance, and data integrity.
• Collaborate with functional QA teams to tailor strategies.
• Drive the digital quality roadmap and process automation aligned with QMS strategy.
• Lead global validation strategy for Generative AI deployment in GxP environments with DX-IT and cross-functional teams.

Governance and Oversight

• Implement Global QA governance for systems like ALTOS, eQMS, QualityDocs, VLM, and related QA data systems per Global SDLC.
• Ensure compliance of global Quality IT systems.
• Oversee IT vendor selection and management, including outsourced/insourced CSV activities.

Implementation and Support

• Lead IT quality strategy implementation in alignment with business goals.
• Provide e-Compliance support for global system deployments, ensuring regulatory compliance.
• Support inspections and audit readiness in collaboration with DX-IT and Functional QA.

Team and Talent Development

• Build and mentor a high-performing global E-Compliance team.
• Foster effective collaboration with DX-IT to meet IT and regulatory requirements.

Risk Management

• Ensure quality oversight for third-party vendors and CSV activities with Functional QA.
• Serve as primary contact for global RDPV QA CSV activities.
• Identify and mitigate computerized system risks with cross-functional teams.
• Represent QA in IT/CSV governance and communicate risks to leadership.

Continuous Improvement

• Lead projects to advance organizational technology and quality.
• Ensure timely closure of operational gaps in e-Compliance QA and IT activities.
• Collaborate with QA audit teams to communicate IT-related observations and risks.

Personal Skills and Professional Experience:

• Minimum 10 years in GxP roles, including 5 years in Global GxP QA or equivalent.
• At least 5 years managing Computerized Systems Validation or quality IT systems globally.
• Strong knowledge of ISPE GAMP 5 (1st edition required, familiarity with 2nd edition preferred).
• Proven leadership with global project and people management experience.
• Bachelor’s degree in a scientific or technical discipline required; Master’s preferred.
• Fluent English and excellent communication skills.
• Enterprise mindset and strong project management skills.
• Deep understanding of quality management systems, GxP regulations, computerized system validation, IT governance, data integrity, and regulatory expectations.
• Excellent collaboration, conflict resolution, and shared accountability skills.