Director, Quality Systems Excellence

Company Description

AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

The Director, R&D Quality Systems provides strategic oversight and leadership for the execution, deployment, and continuous improvement of the R&D Quality System. Leading a team of quality professionals, they are accountable for the maintenance and governance of the R&D Quality System. The Director, R&D Quality Systems actively partners with the R&D organization to plan and implement key quality system initiatives. By monitoring emerging and changing regulations related to pharmaceuticals, devices, and combination products, they ensure a continuous state of compliance and drive updates to the quality system.

Major Responsibilities:

Partner with key stakeholders in R&D to proactively evaluate and monitor the health of the quality system. Drive improvements to enhance operational effectiveness, and address compliance risks, emerging trends and upcoming regulatory changes.

Develop and implement a comprehensive strategy for R&D Quality System excellence that aligns with regulatory requirements, AbbVie policies, and strategic priorities.

Champion large cross-functional process improvement initiatives that promote best practices and operational excellence in quality systems. Utilize a robust project framework and regularly report progress to leadership via the R&D Quality System governance framework.

Maintain and continuously improve the R&D Quality System governance framework. Collaborate 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 to ensure proper alignment and consistency.

Foster a culture of continuous improvement within the Quality Systems team and across the organization. Leverage 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. Ensure 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 required.

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

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 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 Companys 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

Salary: $172,000 – $326,500