Director of Quality Systems Excellence

4 weeks ago

Chicago, Illinois, United States AbbVie Full time
Job Description

AbbVie is seeking a Director, Quality Systems Excellence to provide strategic oversight and leadership for the execution, deployment, and continuous improvement of the R&D Quality System. The successful candidate will lead a team of quality professionals, ensuring the maintenance and governance of the R&D Quality System. They will actively partner with the R&D organization to plan and implement key quality system initiatives, monitoring emerging and changing regulations related to pharmaceuticals, devices, and combination products.

Key Responsibilities:
  • Partner with key stakeholders in R&D to proactively evaluate and monitor the health of the quality system, driving improvements to enhance operational effectiveness and address compliance risks.
  • Develop and implement a comprehensive strategy for R&D Quality System excellence, aligning with regulatory requirements, AbbVie policies, and strategic priorities.
  • Champion large cross-functional process improvement initiatives, promoting best practices and operational excellence in quality systems.
  • Maintain and continuously improve the R&D Quality System governance framework, collaborating with key business partners to define roles, responsibilities, and accountability for the quality system across the R&D organization.
  • Provide guidance to R&D business partners on cross-functional documentation, ensuring proper alignment and consistency.
  • Foster a culture of continuous improvement within the Quality Systems team and across the organization, leveraging benchmarking data from peers and industry leaders to drive best-in-class solutions.
  • Raise awareness about the importance of a Quality Culture and shared accountability for the R&D Quality System.
  • Lead a team of professionals responsible for the ownership, maintenance, and oversight of core quality system processes, ensuring quality system networks are functioning to enable the development and deployment of key initiatives.
  • Serve as a subject matter expert and thought leader for core quality system elements.

Qualifications:

  • Bachelor's degree in science or related field (Chemistry, Pharmacy, Biology, Microbiology, or Engineering).
  • Minimum 12 years of experience with increasing responsibility in GxP Quality and/or Compliance environment.
  • Demonstrated capability to work in a complex global environment with direct reports.
  • Excellent leadership and people management/development skills are required.
  • Strong organizational, strategic thinking, project management, and leadership skills.
  • Proven track record of managing and implementing large cross-functional quality system change initiatives.
  • Ability to operate successfully in a diverse, matrixed global environment to effectively drive and influence change.
  • Excellent written and oral communication skills with all levels of management and personnel.
  • Knowledge of regulatory requirements across GxPs.
  • Experience in two or more of the following areas preferred: Quality Assurance, Compliance, Regulatory, Clinical Operations, Pharmacovigilance, Manufacturing, combination products, or devices.

Additional Information:

  • 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 short-term incentive programs.
  • 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.

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 AbbVie's 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, visit https://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

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