Full Job Description
A sustainable process development and continuous improvement strategy is crucial to Quality Management System in GCP governing R&D. The Compliance Learning Change Management (CLCM) organization resides within Clinical Development Operations to sustain an interconnected process and operations ecosystem by seamlessly empowering teams to connect ideas and create meaningful impact. Strategic Change Enablement (SCE) Manager I is responsible for partnering across CLCM organization to plan and deliver process improvement initiatives that support clinical research processes. Manage the development of clinical research processes including process maps and quality system documents. Provide change management for process improvement initiatives, including stakeholder and impact assessment and communications. Assess metrics and measures for their areas of focus. Leverage knowledge of AbbVie's Quality System, GxP Regulations, and the Business Process Framework (BPF) to deliver process and change management.
Responsibilities
- Responsible for understanding AbbVie's Quality System, GxP Regulations, and the Business Process Framework
- Awareness of Clinical Trial Management Systems and other associated systems for areas of focus
- Understand and partner across CLCM to support process improvement initiatives
- Provide change management for process improvement projects including stakeholder and impact assessment and communications
- Manage development of clinical research processes, including quality system documents and process maps
- Assessment of metrics and measures for their areas of focus
- Maintain initiative and change management application
- Partner across CLCM to assess and align on process improvements
Qualifications
- Bachelor's degree (or equivalent ex-US) is required, typically in a scientific or business field. An Associate's degree (or equivalent ex-US) with relevant experience is acceptable.
- Must have 6+ years of Pharma-related/ clinical research related experience; 2+ years of experience preferably within clinical research.
- Experience in process management, optimization, and simplification work is preferred.
- Experience in change management is preferred.
- Effective leadership skills with a proven ability to foster team productivity and cohesiveness in a Matrix environment.
- Possesses good communication and problem-solving skills
- Change management and/or Lean Six Sigma desired.
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.