Director, Clinical Quality Assurance

BioSpace; North Chicago (IL); On-site; USD 190,000 - 270,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking a Director of Clinical Quality Assurance to provide global quality oversight across therapeutic areas in clinical development. The role ensures compliance with AbbVie policies and worldwide regulations, and leads strategic quality initiatives to embed quality early.

You will drive inspection readiness, CAPA, and continuous improvement in GCP systems, partnering with clinical development leaders and cross-functional teams to achieve R&D goals.

Qualifications

• Extensive knowledge of clinical development and biopharmaceutical quality systems.
• Experience with GCP, ICH guidelines, and global regulatory expectations.
• Proven ability to lead large, cross-functional teams across regions.
• Strong strategic thinking and problem-solving in a fast-paced environment.
• Demonstrated success in inspection readiness and CAPA management.
• Ability to travel 10–20% internationally as required.

Responsibilities

• Develop and implement global quality oversight for Therapeutic Areas in clinical development.
• Ensure compliance with AbbVie policies and worldwide regulations across RDQA.
• Lead strategic quality initiatives to embed quality in development programs.
• Prepare for and manage regulatory inspections and interactions with health authorities.
• Coach Program Managers and build high-performing teams across functions.
• Drive continuous improvement of GCP systems and documentation standards.

Skills

Quality leadership

GCP knowledge

Regulatory compliance

Cross-functional leadership

Audit readiness

Strategic planning

Education

Bachelor's or Master in science or healthcare

Advanced degree or relevant certification

Job 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 atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

Job Description

AbbVie is dedicated to delivering a consistent stream of innovative, safe, and effective medicines and products that solve serious health issues and have a remarkable impact on peoples lives. As a quality organization in research & development, R&D Quality Assurance (RDQA) is committed to driving quality excellence across all stages of discovery and development for the products lifecycle to achieve product realization and accelerate access to innovative therapies and products for our patients. Patient needs, stakeholder demands, industry innovation, regulatory landscape, and AbbVies evolved business strategy are complex, rapid pace, and dynamic. Emphasizing and embedding quality in the execution of clinical trialsensuresdata integrity, fostering regulatory compliance, and contributes to the overall success of drug/device development programs. TheDirector,Clinical QualityAssuranceis responsible fordeveloping and implementingglobalstrategic quality oversight for Therapeutic Areas (TAs) within clinical development programs. This role ensures that R&Dcomplies withcorporate policies and worldwide regulations. This position provides strategic leadership, ensuringinspectionreadiness and delivering comprehensive QA perspectives for assignedTAs.It involves influencing decision-making processes to embed quality requirements within improvement initiatives.With a focus on pro-active quality this role supports Clinical Development globally to ensure; quality excellence, data integrity, the realization of R&D goals and objectives for submission of new therapies, adherence to the AbbVie Quality System and execution of RDQA Quality System Excellence (CAPA, Change Management, Quality Risk Management, Documentation Standards). Scope includes R&D and clinical research activities for the R&D pipeline to achieve first pass approvals thereby advancing the pipeline.The position will report to Senior Director, Clinical QualityAssurance. This role could be based in AbbVie's Lake County, IL/Irvine, CA/ EU/UK

Responsibilities

• Delivers innovative quality strategies and solutions through collaboration within RDQA and R&D personnel, all levels of AbbVie management, otherGxPfunctions, and external service providers to support effective andtimelysolutions/responses to compliance issues/questions.
• Build a strategic, high-performing team within the TAs that canleveragetheir comprehensive understanding of the TA, programs, and upcoming development milestones to build quality into our Development Programs early, prevent risks from impacting submissions and approvals, while increasing success during GCP inspections.
• Connection to Vendor QA and AREA QA upholding the core principles of GCP across the matrix of QA teams supporting development. Engage across QAGxPsand deliver mitigation strategies to critical business partner networks.
• Develop a sustainable, collaborative relationship with clinical development leaders and organizations to ensure, promote, and guide that AbbVie quality systems, qualityobjectives, are understood andmaintainedto achieve AbbVie, R&D and RDQA goals
• Drives development / continuous improvement and implementation of necessary GCP systems by leading and /or collaborating on implementation of cross-functional initiatives to assure compliance to regulations and corporate policies.
• Analyzes and evaluates processes that support clinical developmenttoassurequality and compliance. Leads and develops a team of Program Managers per assigned therapeutic areas in the development and execution of comprehensive quality assurance plans, performance, and Ways We Work Drives for results for self and staff by providing clear direction,establishingstretch goals/assignments andcancommunicate expectations andobjectivesin a clear and well-planned manner.
• Maintains two-way dialogue with others related to work assignments and results,bringsout the best in people. Performs strategic planning toensureresources are available for essential quality assurance activities.
• Provides leadership/collaboration inhealth authorityinspections toassuresuccess and supports resolution of findings by working with development business partners.
• Provides expert consultation and direction on complex quality assurance and GCP complianceinquiriesfrom supported organizations.
• Promotes continuous education on qualityassuranceand GCP guidelines and regulations for self/direct reportsand other AbbVie staff.

Qualifications

• Strong analytical skills and the ability to organize work in a logical,thoroughand succinct manner.
• Ability to work at an experienced level,demonstratingeffective leadership in interactions with business partners at all levels.
• Steps up and takes leadership to own toughest challenges, persisting to achieve the right results for theorganization. Motivates and can influence others, including those over whom they have no direct authority.
• Professional, accountable,energeticand collaborative team player. Ability toadvance relationshipswithin function and business partners.
• Thorough knowledge of quality systems, auditingstandardsand quality management processes. Advanced business acumen, understands complexities of organizational design, working knowledge of current and future practices Extensive knowledge of worldwide regulatory requirements and industry best practices that govern clinical development.
• Ability to work in a fast-paced, high pressure and changing environment in an autonomous manner. Flexibility to adapt to changing conditions and ability to effectively prioritize. Grasps the essence and can change course quickly, whereindicated.
• Project management, interpersonal, and communication skills with the ability to influence.
• Builds strong teams and relationships with peers and cross-functionally at both global and local levels to drive performance.
• Excellent communication skills, including superior negotiation and influencing skills.Acute listening skills to gain understanding or to solve a problem and the ability to recognize the difference.Ability to manage difficult conversations and seek alignment.Ability to motivate and develop high-performing teams with challenging goals that bring growth and development.
• Well-developed leadership competenciesincludemotivation, cultural awareness, active engagement, relationship building, sound judgment, and the management of sensitive proprietary information.
• Ability to direct and coach to prioritize and balance multiple tasks simultaneously to achieve goals and satisfy internal stakeholders.
• Extensive knowledge ofclinicaldevelopment for biopharmaceuticals. Bachelors degree in science (physical, life, health),a healthcare profession (e.g., nursing or pharmacy) or equivalent experience.
• Bachelors or MastersDegree or equivalent education with typically12+yearsin the function or closely related field.Biopharmaceutical industry experience in quality assurance, compliance and/or other related development functions that includes 5 years in leadership positions (people and/or initiatives/projects)
• Ability to travel (on average10-20%) including willingness and ability to perform international travel

Additional Information

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this postingbased on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more orless than the posted range. This range may be modified in thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible to participate in our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission,incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paidandmay be modified at the Companys sole and absolute discretion, consistent withapplicable 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.

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