Job DescriptionJob DescriptionCompany Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.
Job Description
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.
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
- 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.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:
- The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
- This job is eligible to participate in our short-term incentiveprograms.
- This job is eligible to participate in our long-term incentiveprograms
Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Company’s sole and absolute discretion, consistent withapplicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal OpportunityEmployer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
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