Sr. Manager, Analytics & Data Engineering

AbbVie • Worcester, MA

70d

About The Position

We are seeking a result driven and technical oriented Manager- Analytics and Data Integrity to lead site analytics web and data quality initiatives within our pharmaceutical operation reporting into Digital Systems organization. This role is central to ensure that all data used in GxP systems are connected, accurate, secure and in full compliance with AbbVie's global program and regulatory standards including FDA, EMA and MHRA requirements. This role bridges the data stream from strategy, governance and analytics. This role will lead and implement a site strategy in compliance with regulatory and AbbVie global expectations, champion key site initiatives, and contribute to the global Data Integrity Center of Excellence. Execute a vision of world class data governance that serves our patients by managing the site's efforts at driving best practices within the data lifecycle.

Requirements

• Bachelor's Degree required, preferably in Physical or Life Sciences, Pharmacy, or Engineering.
• 10+ years of combined experience in Manufacturing, QA, Engineering, R&D in pharmaceutical, biologics, device or chemical industry.
• Must be familiar with use of electronic document management, Bench Top equipment systems and laboratory information management.
• Must also be familiar with cGMP, Quality Systems, ALCOA+ principles, and other global regulatory requirements of data governance.
• Strong communication skills, both oral and written.
• Expert knowledge of US Code of Federal regulations and the EU regulations.
• Subject Matter Expertise on Data Governance principles, computerized systems and compliance activities.
• Excellent communication and influencing skills at all levels of the organization are required to influence diverse, ad hoc teams of SMEs.
• Demonstrated project management skills and ability to lead effective change management.

Responsibilities

• Implement and maintain Data Integrity compliance activities across the end-to-end product lifecycle and various departments in alignment with relevant regulatory regulations and guidelines.
• Implement data governance framework like metadata, ownership and lineage.
• Establish data mapping and monitor data lifecycle - collection, storage, processing and usage.
• Work closely with data engineers, data scientists, and business units.
• Collaborate with various functional stakeholders to integrate analytics into everyday activities and decision-making processes.
• Collaborate with functional leads and peer teams to define and create analytical products tailored to specific category needs, including definition of the data domain and standards for data enrichment on enterprise-approved platforms.
• Lead the development of advanced analytical models and tools for use cases, ensuring they effectively meet the needs of functional leads and other teams.
• Oversee development and delivery of dashboards, KPI's and business insights.
• Represent AbbVie Worcester site, Data Integrity subject matter expert during internal and external regulatory inspections related to data integrity.
• Ensure adherence to regulatory standards (e.g. FDA, GxP etc.).
• Manage remediation efforts, utilizing risk management-based principles to identify risk and establish appropriate prioritization.
• Manage and guide a team of employees, fostering a culture of innovative problem solving and continuous improvement.
• Build and maintain the team's capabilities to effectively execute analytics strategy, ensuring team members possess the necessary skills and tools to excel in their roles.
• Train staff on data best practices.
• Establish strong partnerships with category leads to understand and anticipate their analytical needs across business areas - Operations, R&D, Commercial, etc.

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k) to eligible employees
• Short-term incentive programs
• Long-term incentive programs

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree