Director, Clinical Process Excellence

A sustainable process development and continuous improvement strategy is an integral part of a Quality Management System in GCP governing Research & Development (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.  The Associate Director Strategic Change Enablement serves as a primary interface between the client and the Compliance Learning Change Management (CLCM) function. Strategic partner with key stakeholders in their areas of focus throughout full lifecycle of strategic initiatives and delivery of solutions from defining business needs project planning development deployment change management and end user adoption that supports operational excellence in clinical trial execution.  Design clinical research processes and ensure alignment with cross-functional stakeholders.

Responsibilities: 

• Responsible for understanding AbbVies Quality System and Regulations related to GXP activities and the Business Process Framework and is able to translate to stakeholders
• Thorough understanding of Clinical Trial Management Systems and other associated systems for areas of focus
• Understand the remit of CLCM in order to leverage their expertise in support of initiative execution
• Design clinical research processes (e.g. through process mapping and workshops) ensuring alignment with cross-functional stakeholders and partnering on strategy for implementation and maintain supporting systems and documentation
• For functions supporting clinical research facilitate design of organizational roles and responsibilities and integrations into AbbVies Quality System
• Develop and deliver on initiative change management strategy including stakeholder and impact assessments initiative communications content development and hosting sessions
• Manage systems and global program(s) that enable delivery of process & change management
• Strategic assessment of metrics and measures for their areas of focus

Qualifications :

• BS or BA required; advanced degree preferred
• 8 years of experience in pharmaceutical healthcare or regulated industry preferred.
• Experience in a leadership role with strong management skills in a complex matrix environment preferably in the healthcare industry.
• Demonstration of successful execution of compliance and training strategy in a fast-paced environment managing multiple priorities effectively using innovative and creative solutions.
• Competent in the application of standard business procedures (SOPs ICH Global Regulations Ethics and Compliance).
• Demonstration of successful coaching/ mentoring people management and communication skills in a matrix environment.
• Effective leadership skills with a proven ability to foster global team productivity and cohesiveness.

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 thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic locationand 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 commissionincentive 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 anduntil 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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Work :

No

Employment Type :

Full-time