Associate Director, Quality Risk Management

Purpose: 

The Associate Director/Director Quality Risk Management is a strategic leader within AbbVies Global Quality Systems team. This role is responsible for driving enterprise-wide excellence and standardization in R&D Quality Risk Management providing expert oversight and fostering a culture of proactive risk identification mitigation and compliance with global regulatory and industry standards. Additionally they will lead the QRM Quality System Network which consists of SMEs and risk practitioners across R&D.  

Responsibilities:  

The Associate Director/Director Quality Risk Management is responsible to: 

• Serve as the strategic owner and leader of the global R&D Quality Risk Management (QRM) system driving sustainable excellence and compliance across functions. 

• Design develop and continuously improve quality systems standards practices and supporting tools ensuring alignment with evolving regulatory and industry expectations. 

• Establish and maintain robust governance structures for QRM proactively identifying assessing and mitigating operational and regulatory risks. 

• Champion and harmonize QRM processes documentation and standards across R&D to achieve consistency and operational alignment. 

• Lead and mentor a global network of QRM subject matter experts (SMEs) and practitioners fostering an enterprise-wide culture of knowledge-sharing collaboration and best practice adoption. 

• Act as the primary consultant and advisor to internal R&D stakeholders providing QRM guidance regulatory updates issue resolution and process implementation support. 

• Oversee the creation maintenance and harmonization of process documentation SOPs and training materials to ensure effective knowledge transfer and compliance. 

• Define monitor and report on key quality and risk metrics using data-driven insights to inform leadership drive continuous improvement and ensure accountability. 

• Ensure organization-wide inspection readiness; represent the company during Health Authority inspections including responding to and defending QRM practices and policies. 

• Proactively monitor and influence external regulatory trends and industry standards advocating for the organization and elevating QRM maturity at both the company and industry level. 

This role is a hybrid role with onsite at either our Lake County IL or Irvine CA sites.

Qualifications :

• Bachelors or advanced degree in a scientific discipline life sciences engineering or a related field. 

• Minimum of 8 years experience in the pharmaceutical or biotechnology industry (or 5 years with an MS/PhD) with relevant focus in quality risk management. 

• Proven leadership experience in matrixed cross-functional environments with demonstrated ability to influence without direct authority. 

• Extensive hands-on experience in Quality Risk Management (QRM) covering multiple domains such as Clinical Operations Pharmacovigilance pre-Clinical or Manufacturing. 

• Deep knowledge of global regulatory frameworks inspection readiness compliance standards and QRM methodologies including maintenance of risk logs/registers. 

• Demonstrated capability to standardize and scale quality and risk management processes globally to enhance operational efficiency and reduce complexity. 

• Strong change agility with a track record of effectively leading organizations through ambiguity and transformation while balancing competing priorities. 

• Exceptional communication interpersonal and mentoring skills including experience engaging with senior leadership and developing SMEs. 

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. 

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 Companys 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  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time