Manager Analytics and Data Integrity

AbbVie • Worcester, MA

1d

About The Position

AbbVie is seeking a results-driven, technically oriented Manager of Analytics and Data Integrity to lead site analytics and data quality initiatives within its pharmaceutical operation. Reporting into the Digital Systems organization, the role ensures data used in GxP systems is connected, accurate, secure, and compliant with AbbVie’s global program and regulatory standards, including FDA, EMA, and MHRA requirements.

The role bridges data strategy, governance, and analytics. It will lead and implement a site strategy aligned with regulatory requirements and AbbVie global expectations, champion site initiatives, and contribute to the global Data Integrity Center of Excellence. The manager will advance data governance and data lifecycle best practices in service of patients, lead analytics integration and product development, represent the Worcester site as a data integrity subject matter expert, and manage and develop a team.

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 at all levels of the organization, 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

• Degree preferably in Physical or Life Sciences, Pharmacy, or Engineering.

Responsibilities

• Implement and maintain data integrity compliance activities across the end-to-end product lifecycle and departments, aligned 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.
• Work closely 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 defining data domains and standards for data enrichment on enterprise-approved platforms.
• Lead development of advanced analytical models and tools that meet the needs of functional leads and other teams.
• Oversee development and delivery of dashboards, KPIs, and business insights.
• Represent the AbbVie Worcester site as a 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 responses.
• Manage and guide a team, fostering innovative problem solving and continuous improvement.
• Build and maintain team capabilities to execute the analytics strategy, ensuring team members have the skills and tools needed for their roles.
• Train staff on data best practices.
• Build strong partnerships with category leads to understand and anticipate analytical needs across Operations, R&D, Commercial, and other business areas.

Benefits

• Paid time off, including vacation, holidays, and sick leave.
• Medical, dental, and vision insurance for eligible employees.
• 401(k) for eligible employees.
• Eligibility to participate in long-term incentive programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager