Specialist Scientific Compliance

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

Key responsibilities

• Act as a compliance liaison on behalf of DevSci scientific personnel conducting pipeline development research and product development activities working with Business Technology Solutions (BTS) QA and other R&D functions
  • Fulfill various roles for Laboratory Information Systems (LIS) and GxP computerbased systems (CBS) including Business System Administrator and Business System Owner
  • Execute GLP Archivist delegate responsibilities
  • Collaborate with crossfunctional stakeholders to ensure LIS and CBS concurrently meet end user needs and remain compliant with GxP data integrity data governance and AbbVie Quality System requirements
  • Support instrument qualification and software validation activities
  • Support audit and inspection activities including fulfilling preaudit/inspection requests acting as an SME during an audit and developing and completing audit commitments
  • Learn new skills and contribute where needed within the team to support an All for One AbbVie approach
• 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
• Work in a teambased crossfunctional environment for daily activities decisionmaking and project focus while exhibiting a onecompliance 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 demonstrated behaviors

Qualifications :

• BS degree in a scientific or IT discipline and 0 years of experience OR Associates degree and 2 years of relevant experience
• Preferred qualifications professional from a scientific discipline who has a minimum of two years of experience supporting IT systems potentially serving as a Business System Administrator for laboratory equipment. OR Someone with a strong IT background who has experience working within or supporting scientific environments and systems.
• Good oral written interpersonal and presentation skills
• Ability to facilitate meetings and work well in a project team environment
• Experience working within GLP GMP and GCP regulations preferred
• Experience working in an R&D environment is preferred
• Working knowledge of drug development process or general scientific terminology preferred
• Experience with laboratory systems/software SNOW and/or KNEAT and platforms (e.g. Microsoft365 and/or SharePoint applications) preferred
• Experience with software validation and understanding of Software Lifecycle Management preferred

Competencies for Position

• Build strong working relationships with team members and crossfunctional 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 quickly change course when applicable
• Raises the bar and is never satisfied with the status quo

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 shortterm 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 Companys sole and absolute discretion unless and until paid and may 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.

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