Manager Analytics and Data Integrity

Job Description

We are seeking a results-driven and technically-oriented Manager of 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.

Responsibilities:

Data Integrity

• 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.

Analytics Management

• 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.

Governance & compliance

• 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.

Leadership

• 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.

Qualifications

• Bachelor’s Degree required, preferably in Physical or Life Sciences, Pharmacy, or Engineering
• 15+ 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.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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