Data Integrity Quality Lead
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Our client, a leading pharmaceutical organization, is seeking a Data Integrity Quality Lead to provide strategic leadership for their global data integrity maturity models. The role focuses on ensuring that all data generated and processed across GxP environments complies with international regulatory requirements and industry best practices while integrating new digital technologies.
- Establish and maintain robust data governance processes, including data quality management, data lifecycle management, and risk mitigation.
- Collaborate with cross-functional teams to identify gaps and develop mitigation plans for data integrity risks.
- Develop and deliver comprehensive training programs on data integrity principles and regulatory requirements for all GxP personnel.
- Act as the primary point of contact for regulatory agencies and internal stakeholders during health authority inspections and audits.
- Monitor industry trends and regulatory updates to ensure organizational practices remain at the forefront of compliance and innovation.
- Author, review, and approve quality documentation such as policies, SOPs, deviations, and change controls related to data integrity.
- Lead transversal improvement initiatives to enhance quality management systems and facilitate the adoption of new digital solutions.
- You possess a Master's degree.
- You bring 8+ years of expertise in GxP Data Integrity and data governance within the life sciences industry.
- You have a deep understanding of Computer System Quality regulations and CSV principles.
- You're experienced in risk analysis methodologies such as FMEA to identify and evaluate complex compliance issues.
- You possess a proven track record of managing GxP inspections and interfacing with global health authorities.
- You have excellent negotiation skills and the ability to influence senior leadership within a matrix organization.
- You are fluent in English.
Nice to Haves
- Familiarity with AI/ML, SaaS, and digital transformation initiatives in a regulated environment.
- Experience with GDPR and data privacy requirements within quality processes.
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