Analyst Jobs

Reporting to the Director, MHI Compliance and Independent Education, External Interactions, the Senior Manager, is accountable for compliance monitoring supporting effective implementation of standards governing external interactions and field medical activities. In accordance with the principles for maintaining a high-quality compliance program, the Senior Manager will implement written procedures and monitoring to support compliant field medical activities. This role will contribute to effective training, conduct monitoring/auditing and recommend and implement corrective and preventive actions.  Primary areas of responsibility will include field engagement and documentation standards. This role is responsible for building positive and collaborative relationships in matrixed and cross-functional team environments incorporating diverse groups across Global Headquarter, Affiliates, therapeutic area teams, Regulatory Affairs, Legal, Office of Ethics and Compliance (OEC) and all functional areas of Medical Affairs + Health Impact (MHI).  

Responsibilities: 

• Execution of the compliance plan through monitoring of activities related to external interactions and field engagement.   

• Implement procedures to support accurate, high quality and compliant scientific communications for AbbVie globally.   

• Actively pursues updates to guidance on regulations and internal policies and their impact on external interaction procedures.  

• Implement procedures to support accurate, high quality and compliant documentation related to entries made into the company’s CRM through active monitoring.   

• Responsible for the review and reporting of compliance performance KPIs and related compliance monitoring for external interactions to mitigate business performance risks. 

• Develops and supports the delivery of supplemental training resources and communications to relevant MHI team members to enhance understanding of the minimum standards for external interactions with healthcare professionals (HCPs). 

• Supports completion of required training by MHI employees through development, maintenance, and reporting of role-based training plans.   

• Bachelor’s degree (or ex-US equivalent) with related health science background:  BSN, BS, BS Pharm.  Advanced degree (PhD, RN, PharmD, RD) or extensive experience in Pharma/Biotech Compliance, Operations and/or performance excellence is preferred.    

• 5-7 years of experience in Pharmaceutical, Biotech or Medical Device industry with Field Medical experience a plus 

• Significant experience (>3 years) in Medical Affairs, Medical Excellence, Medical Operations or a related pharmaceutical/biotechnology function, including leadership of cross-functional initiatives. 

• Experience developing and implementing monitoring oversight for business execution, including reporting and metrics preferred but not required.     

• Ability to influence others without direct authority.   

• Excellent leadership, self-management and organizational skills; able to manage workload, set personal and team priorities and adjust as needed 

• Previous experience in situations of conflict resolution, problem solving, or crisis management preferred.  Excellent interpersonal, communication (both oral and written), and relationship building skills. 

• Able to operate effectively within a matrixed environment, embrace change, and lead implementation of new initiatives; can decide and act without having the total picture and can comfortably handle risk and uncertainty. 

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. 

US & Puerto Rico only - to learn more, visit https://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

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

The Principal Quality Engineer – Digital Regulatory Assurance is responsible for providing regulatory assurance and quality oversight for IT applications, infrastructure platforms, and technology solutions operating within a regulated life sciences environment. This role serves as a senior subject matter expert in Software Lifecycle (SLC) processes, Computer Software Assurance (CSA), infrastructure qualification, regulatory compliance, and quality risk management. 

The incumbent is responsible for modernization of quality processes through automation, data-driven monitoring, dashboards, and AI-enabled solutions that improve compliance effectiveness, streamline SLC activities, and strengthen inspection readiness. This position bridges implementing regulatory requirements, technology solutions, and improvements to processes by enabling AI, automation, and data metrics. 

Responsibilities: 

• Provide quality and regulatory oversight for GxP-relevant applications, infrastructure platforms, and technology solutions throughout the Software Lifecycle (SLC), ensuring compliance with regulatory requirements, company standards, and quality expectations. 
• Act as a trusted advisor on SLC, Computer Software Assurance (CSA), validation, infrastructure qualification, risk management, and regulatory compliance within a regulated life sciences environment. 
• Lead compliance monitoring activities across assigned portfolios, including periodic reviews, audit trail reviews, validation health assessments, quality metrics, and overall lifecycle health reporting. 
• Partner with business and technology teams to ensure quality, compliance, and validation requirements are built into the design, implementation, deployment, and ongoing support of technology solutions. 
• Provide guidance on validation strategies, risk assessments, regulatory characterizations, deviations, CAPAs, audit observations, and other quality-related decisions. 
• Lead audit and inspection readiness efforts, including preparation activities, evidence reviews, stakeholder coaching, audit support, and remediation planning. 
• Drive CAPA and audit action management activities by promoting effective root cause analysis, sustainable corrective actions, timely implementation, and verification of effectiveness. 
• Stay current on evolving regulatory requirements, industry trends, and emerging quality practices, and translate them into practical improvements for lifecycle processes and compliance programs. 
• Serve as the primary SQA point of contact for digital process improvement initiatives, helping identify opportunities for standardization, automation, simplification, and AI enablement. 
• Manage a pipeline of automation and AI opportunities, working with stakeholders and technical teams to prioritize, implement, and drive adoption of solutions that improve quality and compliance outcomes. 
• Develop and maintain quality dashboards, compliance scorecards, key risk indicators, and executive reporting to provide visibility into compliance health, operational performance, and emerging risks. 
• Facilitate governance reviews and cross-functional discussions to drive accountability, resolve compliance concerns, and support consistent application of quality and regulatory expectations. 
• Coach and mentor practitioners and project teams on lifecycle execution, CSA principles, validation expectations, inspection readiness, and quality risk management. 
• Represent SQA in governance forums, audits, inspections, and strategic initiatives, communicating risks, trends, and recommendations to business stakeholders and leadership. 
• Lead continuous improvement efforts that strengthen quality processes, enhance compliance monitoring, and support AbbVie's digital quality transformation.

Required:

• Bachelor’s Degree in Engineering, Computer Science, Life Sciences, or related discipline with 7 years' experience; OR Master's Degree with 6 years' experience; OR PhD with 2 years' experience.
• Strong experience in process optimization, AI enabled solutioning, audit-readiness, CAPAs and using/supporting DevOps tools and pipeline technologies. 
• Experience supporting regulatory audits/inspections and implementing quality monitoring solutions. 
• Project management, analytical, and documentation skills; ability to create knowledge materials and coach diverse audiences. 
• Knowledge of Computer Software Assurance (CSA), digital transformation in quality, and contemporary validation practices. 
• Expert knowledge of GxP regulations required.

Preferred: 

• Master's Degree with minimum 6 years' supervisory experience preferred. 
• Knowledge of other regulatory domain areas like SOX, Privacy, Security, AI/ML preferred. 
• Professional certifications (e.g., ASQ CQA, PMP, Six Sigma) preferred. 

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. 

US & Puerto Rico only - to learn more, visit https://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

About AbbVie

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 including immunology, oncology, and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Purpose

Describe the primary goals, objectives or functions or outputs of this position.

The Business System Analyst are individual contributors to the development, maintenance and enhancement of business applications, providing specialized technical or business knowledge to system projects. The position has the responsibility for the management of applications and data residing in the application. The Business Systems Analyst maintain the application’s data and monitor performance and accessibility. The position will be instrumental in the development, identification and implementation of system modifications that will improve productivity within the system(s).

Responsibilities

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Consults with functional areas to develop understanding of the varied and complex business needs supported by the system. Responsible for determining how changing business needs will affect the system. Understands the role of the system in the big picture and provides ideas and recommendations regarding the evolution of the system.
• Responds to questions and influences the users regarding current and potential system inputs, processes, and outputs. Conducts research and analysis into the nature, effect and results of system problems. Develops detailed business user requirements, system documentation, work flow procedures, and data modeling. Negotiates plans, time frames and trade-offs while ensuring client understands the final results of the project.
• Reviews and routes requested system changes and develops detailed specifications for implementation. Communicates system changes and issues to next level of management.
• Ensures current and accurate system documentation, coordinates and or performs testing of system modifications, both validated and non-validated systems. Provides systems expertise and supports system training, educational tools and materials. Involved with the Purchasing Systems Manager regarding planning/scheduling and resource allocation.
• Produces requirements for mainframe reports, time lines, and graphics using advanced functions of a personal computer. Creates reports from existing client databases to satisfy user requests, development of ad-hoc database reporting, data sampling, project analysis, or testing verification.
• Monitors and audits the use of the systems; executes system control practices and purchasing procedures for regulatory and compliance.
• Accountable to the purchasing customer and purchasing management for the control and administration of purchasing systems. Systems implemented must meet projected timelines and customer expectations. The incumbent supports various mainframe, Lotus Notes, stand-alone applications, divisional interfaced systems that impact the overall purchasing process.

#LI-JW1

 

Qualifications

List required and preferred qualifications (up to 10). Include education, skills and experience.

• Bachelor's degree and 2 years experience or Master's degree in Information Systems or related field is required.
• Experience in the systems development, implementation, and operations of a large-scale, enterprise systems.
• Excellent interpersonal skills and well-developed verbal and written communication skills.
• Must be able to effectively lead and facilitate meetings with customers and technical team members.
• Must be deliverables focused and detail oriented.
• Must exhibit exceptional teamwork skills.
• Must have a strong customer focus.

​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 short-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. 

US & Puerto Rico only - to learn more, visit https://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

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

The Senior Analyst, Language Systems and Processes ensures the Center of Language Excellence (CoLE)’s language ecosystem, workflows, and governance operate effectively, consistently, and in alignment with business needs, quality expectations, and compliance requirements. The role translates business and functional needs into clear requirements, process designs, configuration standards, validation criteria, and adoption plans. It serves as a key interface between business stakeholders, the Change, Enablement and Communication function, Language Assets, Quality & Governance team, IT/vendors, the Managed Service Provider (MSP), and the Technical Lead (ITSO), who owns the underlying technical architecture, platform operations, and AI enablement.

Responsibilities:

Functional Consulting and Workflow Design 

• Serve as the primary functional consultant for the language ecosystem. Advise stakeholders on fit-for-purpose solutions and lead the onboarding of new business functions and use cases. 
• Gather, prioritize, and translate business needs into clear functional requirements and user stories for technical and operational teams. 
• Design and document end-to-end language workflows with the Language Assets, Quality & Governance team, making sure they meet regulatory, data privacy and compliance requirements.
• Define and maintain process standards and controls so language workflows run consistently and to a high standard. 

Release Governance and Support 

• Partner with the Tech Lead, IT, vendors, and the MSP to evaluate new language technologies, including AI capabilities, and to confirm readiness before release. 
• Triage incidents and enhancement requests, identify root causes, and escalate to technical partners. Own the follow-up until each issue is resolved. 
• Run intake, prioritization, and release planning. Provide input to the technology roadmap and communicate scope, risks, and decisions to stakeholders. 

Continuous Improvement, Documentation and Adoption 

• Drive continuous improvement through stakeholder feedback, standardization, and innovation. 
• Keep functional and process documentation up to date to support operational continuity and compliance. 
• Support the Change, Enablement and Communication function in developing training materials and driving adoption of new features, standards, and workflows. 

 

• Bachelor’s Degree in Information System or related discipline plus 5 years of experience; Master’s Degree plus 4 years of experience. 
• Respective years of experience in translation and language services, language operations, workflow design, and/or systems/process consulting.
• Profound knowledge of language technology, workflow tools, AI-enabled capabilities, and enterprise process governance. 
• Ability to collaborate effectively with business stakeholders, IT, and vendors. 
• Strong project and priority management skills, with the ability to manage cross-functional and international collaboration.
• Strong understanding of regulated environments, documentation practices, and quality/compliance expectations. 
• Demonstrated creative outside the box thinking to improve processes and champion new technologies to achieve project and strategic goals. 
• Excellent written and verbal English skills.

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 short-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. 

US & Puerto Rico only - to learn more, visit https://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

About AbbVie

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 including immunology, oncology, and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.