Apply

Ready to go for it?

AI Apply speeds things up—apply directly if you prefer.

FREE ACCESS
5,000–10,000 jobs/day
Scoutfield Logo

See all jobs on Scoutfield

Search thousands of fresh jobs every day.

Discover
  • Fresh listings
  • Fast filters
  • No subscription required
Create a free account and start exploring right away.
Octapharma

Global Quality Strategy Expert – Data Analytics & AI

Octapharma

. Develop and implement the global quality strategy, oversight models and frameworks for Clinical Data Management, Governance, Analytics, Biostatistics, Digital Technologies and AI-enabled systems .

Posted 10/21/2026full-timeVienna • AustriaSeniorLead💰 €4,356 per monthWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive expertise in GxP Quality Assurance, particularly in Clinical Data Management and Biostatistics, while effectively leading digital transformation initiatives involving AI and machine learning. Proficient in managing quality risks and ensuring compliance with evolving regulatory standards in the pharmaceutical industry.

Highest-signal resume keywords
GxP Quality AssuranceClinical Data ManagementAI/ML-Enabled Systems AssessmentRegulatory Inspection SupportStakeholder Management

ATS Keywords

Tailor your resume
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Clinical Data ManagementBiostatisticsStatistical ProgrammingComputerized Systems ValidationData IntegrityRisk-Based AnalyticsAI Governance ControlsChange ManagementDigital TechnologiesMachine Learning
Soft Skills
Stakeholder ManagementOrganizational SkillsProactive MindsetInfluencing SkillsMentoring
Tools & Technologies
AI-Enabled PlatformsCloud-Based TechnologiesEDC SystemsClinical DatabasesDigital Processes
Industry Keywords
Pharmaceutical IndustryCRO IndustryRegulatory ExpectationsFDAEMAMHRAQuality ManagementGovernanceData GovernanceQuality Assurance

Tech Stack

Tools & technologies
Cloud

About the role

Key responsibilities & impact
  • Develop and implement the global quality strategy, oversight models and frameworks for Clinical Data Management, Governance, Analytics, Biostatistics, Digital Technologies and AI-enabled systems
  • Provide quality leadership for digital transformation initiatives, including machine learning and generative AI applications, embedding data governance, data integrity and quality-by-design principles in digital processes
  • Drive risk-based analytics to proactively identify and manage quality risks through advanced analytical methodologies and data-driven insights
  • Evaluate AI governance controls, model lifecycle management, training data integrity, explainability, bias mitigation and change management
  • Provide independent quality assessment of AI use cases in clinical development and operational processes
  • Monitor evolving regulatory expectations related to AI in regulated environments
  • Advise Quality, Clinical Development, Data Sciences, Digital Innovation and Regulatory teams
  • Present Quality Assurance in governance committees and strategic initiatives
  • Mentor QA auditors and quality professionals in digital and AI auditing methodologies
  • Lead and conduct global GxP activities and audits of CROs and technology vendors, including clinical data management, biostatistics and statistical programming, EDC systems, clinical databases, AI/ML-enabled platforms, computerized systems and cloud-based technologies

Requirements

What you’ll need
  • Completed degree in Life Sciences, Statistics, Computer Science, Data Science, Quality Management, or related discipline
  • At least 10 years of working experience in the Pharmaceutical or CRO Industry
  • Extensive GxP Quality Assurance and auditing experience, including Clinical Data Management, Biostatistics and Statistical Programming, Computerized Systems Validation, and Data Integrity
  • Demonstrated experience assessing AI/ML-enabled systems and digital technologies
  • Experience supporting FDA, EMA, MHRA and other regulatory inspections
  • Excellent stakeholder management skills with the ability to influence senior internal and external partners
  • Excellent organizational skills, a proactive mindset and ability to manage multiple strategic priorities
  • Fluent in English; German is a plus
  • Willingness to travel internationally as required

Benefits

Comp & perks
  • Company restaurant & meal subsidy
  • Training & further education
  • Health promotion
  • Parking spaces and good public transport connections
  • Company and team events
  • Salary above the collective-agreement minimum may be offered based on individual profile and qualifications