Data Manager, ACDS Informatics

Role: Data Manager in the ACDS Informatics team, responsible for delivering compliant analytical data and reports to support regulatory submissions, inspections, and scientific decision-making throughout pharmaceutical development. Responsibilities include designing automated data workflows, developing dashboards using tools like Spotfire and Power BI, translating scientific and regulatory needs into scalable digital solutions, and promoting data standards and democratization. The role collaborates closely with scientists, regulatory, and digital teams to enhance data accessibility, integrity, and efficiency, while supporting laboratory informatics platform improvements and governance. Qualifications: Bachelor's in Chemistry, Pharma Sciences, Biology, Data Science, or related field with ≥10 years (or MS with ≥6, PhD with ≥3). Extensive experience in pharmaceutical data management, GxP-regulated environments, laboratory informatics (LIMS), analytics, and regulatory support. Skills in data visualization, SQL, SAS, process automation, and digital transformation are required. Preferred skills include familiarity with analytical laboratory informatics platforms, CMC regulatory submissions, cloud analytics, and advanced technologies like GenAI and machine learning. The position involves approximately 10% travel, reports to senior management, and is based in a flexible work setup. High-value biopharma specifics include focus on pharmaceutical development lifecycle, regulatory compliance, data integrity, and leveraging digital and analytics platforms to optimize laboratory and regulatory workflows.