Senior Director, Data Integrity Quality Assurance

Role: Senior Director, Data Integrity Quality Assurance, leading global data integrity strategy and governance across GxP operations in a clinical-stage oncology biotech. Responsibilities: establish risk-based frameworks, oversee computerized system validation, ensure compliance with electronic record regulations (21 CFR Part 11, EU GMP Annex 11), partner with IT and functional teams on lifecycle management of GxP systems, lead inspection readiness, and develop enterprise-wide training programs. Manage internal and external audits, and serve as subject-matter expert for regulatory inspections. Build and develop a high-performing Data Integrity team, advise senior leadership on compliance risks and trends, and foster a culture of data ownership. Qualifications: Bachelor's in Life Sciences, Engineering, or related field; 12+ years in GxP Quality/Data Integrity/CSV within pharma/biotech, including 5+ years leadership; proven success with regulatory inspections (FDA, EMA, MHRA). Preferred: advanced degree, certifications such as CQA or CISA. High-Value: focus on data integrity in regulated biotech environment, CSV expertise, global GxP compliance, and experience supporting inspections. Work setup: likely hybrid with domestic/international travel (up to 20%).