Specialist, Scientific Compliance

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.

This position resides within Scientific Compliance, Development Sciences. The candidate will ensure compliance in a GMP, GLP and GCP environment with global regulatory, inspecting agency, corporate, ICH, and Office of Ethics andCompliance requirements.The successful candidate must remain current with major compliance trends and application within the pharmaceutical industry. The position requires proactive evaluation of organizational compliance needs and recognition of opportunities to improve business efficiency and productivity.

Responsibilities:

• Establish, implement, and maintain training courses in a Learning Management System (LMS) to electronically deliver and track training for scientific personnel conducting pipeline development research and product development activities.
  • Collaborates with LMS team colleagues and functional area management to determine and implement personnel training requirements
  • Gathers and processes training-related needs for onboarding, current, and offboarding personnel
  • Coordinates LMS training plans and courses commensurate with established personnel role and responsibilities, aligned with organizational standards
  • Ensures timely processing of training plan changes in the LMS and related associated systems
  • Monitors and communicates to ensure personnel training is completed according to established timelines and metrics reporting expectations
  • Assists business areas in maintaining training documentation and associated materials for personnel qualifications/assessments
  • Support audit and inspection activities, including fulfilling pre-audit/inspection requests, acting as an SME during an audit and developing and completing audit commitments
• Support Compliance/Business/QA partnership needs and initiatives for continuous improvement to enhance efficiency and compliance
  • Provide input to regulatory and compliance requirements/expectations
  • Identify and appropriately escalate potential compliance risks and/or issues as they arise
  • Use sound and balanced judgment to discern the criticality of issues and act upon them accordingly
  • Identify potential compliance risks and provide potential solutions, including implementation of solutions
  • Manage compliance and process improvement projects to enhance efficiency and compliance
  • Contribute to the development and shaping of quality system policy, process, and procedure
  • Willingness to learn new skills and contribute where needed in an All for One AbbVie approach
• Work in a highly team-based, cross-functional environment for daily activities, decision-making, and project focus while exhibiting a one-compliance voice approach
  • Identify and recommend practical solutions for improved business process efficiency
  • Ability to manage several tasks simultaneously while ensuring all timelines are met
  • Anticipate and respond to urgent and/or unexpected events and changing business needs with minimal impact on productivity
  • Ability to work to identify and solve issues as they arise with minimal supervision
  • Create an open and trusting environment through constructive communication and example

• BS degree and 7 years experience or MS degree and 5 years experience in a scientific discipline or workforce education and training/administration role, or equivalent experience
• Working knowledge and experience with GxP regulations, processes, procedures, and documentation requirements for scientific studies and publications
• Direct experience with ComplianceWire LMS or similar (ISOtrain, Microsoft Viva, Docebo, Absorb, Academy), and OneVault DMS or similar DMS are highly preferred
• Experience with electronic system data management, trending, and metrics
• Experience working with process, procedure, and document change control processes preferred
• Ability to facilitate discussions and/or meetings while working in a matrixed environment
• Good interpersonal, presentation, and scientific writing skills

Competencies for Position

• Builds strong working relationships with team members and cross-functional business partners
• Embraces the ideas of others, nurtures innovation, and manages innovation to reality
• Create an open and trusting environment through constructive communication and example
• Learns fast, grasps the "essence, and can change course quickly where indicated
• Raises the bar and is never satisfied with the status quo

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 ingood faith it will pay for this role at the time of this posting based on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay 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/visioninsurance and 401(k) to eligible employees.

• This job is eligible to participate in our short-term incentive programs.

Note: No amount of payis considered to bewages 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 benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid andmay be modified at the Companys 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, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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