Manager Analytics and Data Integrity

AbbVie•Worcester, MA

1d•$124,500 - $236,500

About The Position

AbbVie is seeking a results-driven, technically oriented Manager of Analytics and Data Integrity to lead site analytics, web, and data quality initiatives within a pharmaceutical operation. Reporting into the Digital Systems organization, this role ensures data used in GxP systems is connected, accurate, secure, and compliant with AbbVie’s global program and applicable regulatory standards, including FDA, EMA, and MHRA requirements. The role bridges data strategy, governance, and analytics. It leads implementation of a compliant site strategy, champions site initiatives, and contributes to the global Data Integrity Center of Excellence. The manager advances data governance across the data lifecycle, supports analytics adoption and delivery, serves as a data integrity subject matter expert during regulatory inspections, and manages and develops a team. The position partners with stakeholders across Operations, R&D, Commercial, and other business areas.

Requirements

Bachelor’s degree required.
15+ years of combined experience in Manufacturing, QA, Engineering, or R&D in the pharmaceutical, biologics, device, or chemical industry.
Familiarity with electronic document management, bench-top equipment systems, and laboratory information management.
Familiarity with cGMP, Quality Systems, ALCOA+ principles, and other global regulatory requirements for data governance.
Strong oral and written communication skills.
Expert knowledge of the US Code of Federal Regulations and EU regulations.
Subject matter expertise in data governance principles, computerized systems, and compliance activities.
Excellent communication and influencing skills, including the ability to influence diverse, ad hoc teams of subject matter experts.
Demonstrated project management skills and ability to lead effective change management.

Nice To Haves

A degree in Physical or Life Sciences, Pharmacy, or Engineering is preferred.

Responsibilities

Implement and maintain data integrity compliance activities across the end-to-end product lifecycle and departments, in alignment with relevant regulations and guidelines.
Implement data governance frameworks covering metadata, ownership, and lineage.
Establish data mapping and monitor the data lifecycle, including collection, storage, processing, and usage, working with data engineers, data scientists, and business units.
Collaborate with functional stakeholders to integrate analytics into everyday activities and decision-making.
Work with functional leads and peer teams to define and create analytical products tailored to category needs, including data domains and data-enrichment standards on enterprise-approved platforms.
Lead development of advanced analytical models and tools for use cases, ensuring they meet functional leads’ and other teams’ needs.
Oversee development and delivery of dashboards, KPIs, and business insights.
Represent the AbbVie Worcester site as the Data Integrity subject matter expert during internal and external regulatory inspections.
Ensure adherence to regulatory standards, including FDA and GxP requirements.
Manage remediation efforts using risk-management principles to identify risks and prioritize actions appropriately.
Manage and guide a team, fostering innovative problem-solving and continuous improvement.
Build and maintain team capabilities to execute analytics strategy, ensuring team members have the skills and tools needed for their roles.
Train staff on data best practices.
Partner with category leads to understand and anticipate analytical needs across Operations, R&D, Commercial, and other business areas.