Principal Analyst, Global Analytics & Data Sciences Quality and Compliance

The Principal Analyst, Quality & Compliance provides leadership for compliance and quality activities across Global Analytics and Data Sciences (ADS). He/She is responsible for addressing compliance requests and questions, for ensuring inspection readiness and for providing quality and compliance training to the ADS department. He/She plays a pivotal role supporting closure of the most complex and important regulatory agency commitments and CAPAs specific to ADS. He/She consults and provides guidance for other departments on ADS specific quality regulations, expectations, and best-practices.

Principal Accountabilities

• Provide guidance and support to ADS staff in the area of regulatory compliance and best practices. Serve as a liaison between ADS and R&D Quality and Compliance. Assist with CAPAs, Memos to file, deviations and other compliance related items. Maintain expertise in regulations, guidance and best practices related to data integrity and all ADS activities.
• Coordinate ADS-related internal and external audits and inspections. Provide leadership, training and support to inspection teams. Support closure of regulatory agency commitments and CAPAs specific to ADS.
• Lead and/or contribute to ADS and cross-functional initiatives related to quality and compliance. Participate in the identification of gaps in process or documentation and leads teams to implement solutions.
• Provides training on regulations, expectations, and best-practices.
• 10+ years relevant work experience in related position(s) with a focus on data management and/or data analysis
• Expertise in global industry regulations and best practices (E.g. Data Integrity, GCP, 21 CFR Part 11)
• Experience with regulatory inspec

The Principal Analyst, Quality & Compliance provides leadership for compliance and quality activities across Global Analytics and Data Sciences (ADS). He/She is responsible for addressing compliance requests and questions, for ensuring inspection readiness and for providing quality and compliance training to the ADS department.