Data Integrity Quality Lead

Il y a 6 heures

Brainel'Alleud, Wallonia, Belgique Pauwels Consulting Temps plein
pOur 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. /pulliEstablish and maintain robust data governance processes, including data quality management, data lifecycle management, and risk mitigation. /liliCollaborate with cross-functional teams to identify gaps and develop mitigation plans for data integrity risks. /liliDevelop and deliver comprehensive training programs on data integrity principles and regulatory requirements for all GxP personnel. /liliAct as the primary point of contact for regulatory agencies and internal stakeholders during health authority inspections and audits. /liliMonitor industry trends and regulatory updates to ensure organizational practices remain at the forefront of compliance and innovation. /liliAuthor, review, and approve quality documentation such as policies, SOPs, deviations, and change controls related to data integrity. /liliLead transversal improvement initiatives to enhance quality management systems and facilitate the adoption of new digital solutions. /li /ululliYou possess a Master's degree. /liliYou bring 8+ years of expertise in bGxP Data Integrity /b and bdata governance /b within the life sciences industry. /liliYou have a deep understanding of bComputer System Quality /b regulations and bCSV /b principles. /liliYou're experienced in risk analysis methodologies such as bFMEA /b to identify and evaluate complex compliance issues. /liliYou possess a proven track record of managing bGxP inspections /b and interfacing with global health authorities. /liliYou have excellent negotiation skills and the ability to influence senior leadership within a matrix organization. /liliYou are fluent in bEnglish /b. /li /ulh3Nice to Haves /h3ulliFamiliarity with bAI/ML /b, bSaaS /b, and digital transformation initiatives in a regulated environment. /liliExperience with bGDPR /b and data privacy requirements within quality processes. /li /ul