Director, Quality Systems

Company Description

AbbVie's 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 people's 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 Quality Systems Director Documentation and Training serves as a leading subject matter expert and project manager for the quality oversight and continuous improvement of the AbbVie Documentation and Training Quality Systems. The QS Director leads a team of quality training and documentation professionals who are accountable for processing global documentation and developing and delivering effective training to Operations employees globally. As such, the QS Director must maintain current subject matter expertise in the latest developments in global pharmaceutical quality systems. The QS Director ensures state of compliance for training and documentation systems to include monitoring emerging or changing regulations related to pharmaceuticals, devices and combination product and applying them as necessary.

Responsibilities:

• Provide leadership and direction on documentation and training processes across Abbvie Global Operations.
• Obtain and leverage benchmarking data from peers and industry leaders to ensure best-in-class documentation solutions and learning services for AbbVie quality and compliance.
• Provide tools, technology, and resources that drive consistency, quality, and improved accessibility to enhance training effectiveness.
• Lead cross-functional team (Center of Excellence) focused on standardization, best practices, execution of programs, and continuous improvement as it relates to the overall documentation and training systems.
• Manage the AbbVie quality system policy on personnel and documentation. Ensure state of compliance for training and documentation system to include monitoring emerging or changing regulations related to pharmaceuticals, devices and combination products.
• Serve on short duration teams chartered with achieving synergies with other Quality organizations (e.g.-R&D and Regulatory).
• Serve as a key leader in knowledge management processes via Regulatory Intelligence Process that better enables AbbVie to achieve an improved, current and contemporary quality system.

Qualifications

• Position requires BS degree in a science related area.
• 15+ years of Quality, Regulatory and/or Operations experience with significant situational leadership experience.
• This role requires strong organizational skills, strategic thinking, project management and leadership skills.
• The incumbent must also have a solid understanding of the quality and regulatory requirements of pharmaceutical, device and combination products.
• Requires an in-depth understanding of Quality Systems and related processes.
• The position requires human relations and administrative skills necessary to establish and maintain effective working relationships with team members, co-leaders and senior management in quality, manufacturing, supply chain, finance, information systems, and engineering.
• The individual must possess sound judgment in evaluating and establishing compliance strategic plans as well as in day-to-day situations.
• Conflict resolution skills including persuasive management techniques required. Strong oral and written communication skills needed.
• Excellent presentation and interpersonal skills required.

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 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