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Safety Deliverable Excellence Director

1 month ago

Chicago, Illinois, United States AbbVie Full time

This role is primarily responsible for driving safety deliverable excellence and overseeing the timely completion and submission of safety deliverables within assigned teams, ensuring associated deliverable quality expectations are met.

In addition, this role works as part of the Safety Deliverable Excellence Leadership Team to develop, implement, maintain, and monitor optimized processes for and quality execution of safety deliverables.

Responsibilities:

  • Managerial oversight of assigned internal and external employees/resources, delegating effectively with oversight to empower, leverage, and develop staff.
  • Responsible for building and nurturing a culture of safety deliverable excellence.
  • Contribute to and support the implementation of the Safety Deliverable Excellence vision, strategies, and objectives (deliverable quality, timeliness, and efficiencies).
  • Conceive, lead, and/or contribute to major process improvements, system enhancements, or other projects impacting PPS Safety Deliverables.
  • Provide execution leadership to direct reports for all initiatives related to safety deliverable excellence.
  • Build strong strategic partnerships with stakeholders and leverage relationships to advance the Safety Deliverable Excellence vision and drive consistent stakeholder understanding and application of quality principles related to safety deliverables.
  • Responsible for audit and inspection preparation strategy and execution activities (related to safety deliverables).
  • Leads and oversees responses to audit requests.
  • Acts as a subject matter expert where required and may be interviewed during audits and inspections.
  • Interpret current and emerging guidance and regulations that impact PST safety deliverables.
  • Identify and drive recommended actions (where applicable) to ensure compliance with regulations.
  • In collaboration with the Business Process Owner (BPO) office, create (and update as appropriate), manage, and monitor: safety deliverable processes, guidelines, and templates, and compliance and performance metrics.
  • Seeks to understand non-compliance issues and root causes and implement measures to address gaps.
  • Strategic management and oversight of PST safety deliverables, as needed, including development of PST safety deliverable strategies, project plans, confirming accountabilities, driving document quality, completion of actions, and escalating obstacles/risks.

Qualifications:

  • Bachelor's degree (with related health science discipline preferred).
  • Minimum of 3 years' pharmaceutical industry experience or equivalent experience in a regulated industry.
  • Demonstrated knowledge of safety deliverable development, requirements, and associated regulations.
  • Demonstrated people management experience preferred.
  • Strong leadership presence. Ability to work directly with and influence senior management. Decisive yet collaborative leadership style.
  • Proven ability to lead, manage, and motivate others in a complex, multi-functional matrix environment preferred.