Director, Quality Systems

Job Description

Job Description

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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Purpose Statement

This role serves to provide leadership in the Quality Operations function to support and drive strategic initiatives, continuous improvement and management of the Quality Center of Excellence in cooperation with the Center of Excellence leads. This position holder will hold responsibility for working closely with regulatory intelligence team and improve AbbVie Global Quality System by ensuring external and internal regulatory and business signals are translated into improvements of the different Quality System elements to consistently deliver compliance and high-quality product. These signals include new or changed external regulations, observations from AbbVie´s regulatory inspections and competitor’s enforcement actions, AbbVie´s strategic objectives and continuous improvement needs.  The responsibilities, qualifications and experience required for this position are presented below.

Major Responsibilities :

• Provide directions, leadership and guidance to the Center of Excellence Leads (CoE) in a matrix organization (currently 18 global CoE Leads, mostly on a Director- or Associate Director level across 20 Centers of Excellence)
• Manage the Quality System and Centers of Excellence to ensure alignment with regulatory standards and guidance. Drive a continuous improvement philosophy to ensure the CoEs are being managed to deliver a quality system that consistently meets regulatory requirements. Drive alignment of CoE activities with the Global Operations Quality strategy.
• Own, drive and continuously improve the process to identify relevant enforcement actions of key regulatory agencies including FDA, EMA, MHRA, HPRA for AbbVie's peers. In collaboration with global CoE leads, assess the potential impact on AbbVie's quality system and identify appropriate actions.
• Work with relevant cross-functional teams to investigate operational / process inefficiencies for the identified initiatives and working with the business to design improvements and implement efficient / effective systems. Project Manage Quality Operations process improvement initiatives to address the identified inefficiencies in partnership with the process owner and relevant stakeholders.
• Ensure that findings during inspections at one site or affiliate are assessed for potential impact on the global network (all other manufacturing sites or affiliates). Work with the CoEs to close identified gaps.
• Lead and coordinate activities in support of mergers, acquisitions, and divestitures through the integration of the quality system
• Provide mentorship, leadership, and prioritization to team members to execute their respective duties.
• Lead, coordinate, and engage the CoE Team and manage CoE-related resources like SharePoint, SME-lists, annual plans; conduct Community of Practice (CoP) meetings

Qualifications

Qualifications

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 and serving our community.  Equal Opportunity Employer / Veterans / Disabled.

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