Associate Director, Quality Risk Management

BioSpace; Irvine (CA); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Comprehensive benefits package

Paid time off

401(k) plan

Short-term incentive programs

Job summary

A biopharmaceutical company in California is seeking an Associate Director for Quality Risk Management. The role involves leading a global network, improving quality systems, and ensuring compliance in a fast-paced, complex environment. Ideal candidates will have over 8 years of experience in the pharma industry, with a strong focus on Quality Risk Management. The position is hybrid, allowing for a flexible work schedule.

Qualifications

• 8+ years of experience in the pharmaceutical or biotechnology industry.
• Proven leadership experience in matrixed environments.
• Extensive hands-on experience in Quality Risk Management spanning multiple domains.

Responsibilities

• Drive sustainable excellence and compliance across functions.
• Develop and improve quality systems and practices.
• Lead a global network of QRM subject matter experts.
• Harmonize QRM processes across R&D.
• Lead a global QRM SMEs network.
• Advise R&D stakeholders on QRM and regulatory updates.
• Oversee docs, SOPs, training materials for compliance.
• Define and report quality/risk metrics to leadership.
• Ensure inspection readiness; respond to inspections.
• Monitor external regulatory trends; raise QRM maturity.

Skills

Leadership in cross-functional environments

Quality Risk Management

Strategic thinking

Regulatory compliance knowledge

Communication skills

Education

Bachelor's or advanced degree in a scientific discipline

MS/PhD in a related field

Job description

Associate Director, Quality Risk Management

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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, eye care) and products/services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit www.abbvie.com. Follow us on X, Facebook, Instagram, YouTube, LinkedIn and TikTok.

Purpose

The Associate Director/Director, Quality Risk Management is a strategic leader within AbbVie's 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

• 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

• 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.

Equal Opportunity Employer

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