Principal Analyst, Global Analytics & Data Sciences Quality and Compliance

Biogen SANDBOX • Cambridge, MA

3d

About The Position

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.

Requirements

• 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

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: No Education Listed
• Number of Employees: 1,001-5,000 employees