VP of Clinical Quality Assurance
4 weeks ago
AbbVie is dedicated to delivering a consistent stream of innovative, safe, and effective quality medicines and products that solve serious health issues and have a remarkable impact on people’s lives. As a quality organization in research & development, R&D Quality Assurance is committed to driving quality excellence across all stages of discovery and development for the product’s 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 AbbVie’s evolved business strategy are complex, rapid pace, and dynamic. Emphasizing and embedding quality in the execution of clinical trials, assures patient safety, maintains data integrity, fosters regulatory compliance, and contributes to the overall success of drug/device development programs. An elevated, focused, and evolved Good Clinical Practices (GCP) strategy and pipeline partnership are essential. The Vice President Clinical Quality Assurance is a key role in R&D, responsible for leading the Clinical Quality Assurance function and partnering with AbbVie’s R&D Clinical Development organization to achieve consistent high-quality clinical research outcomes.
The VP Clinical Quality Assurance provides strategic leadership and direction for clinical quality assurance operations, ensuring compliance with regulatory standards and driving continuous improvement of Good Clinical Practices (GCPs). The role collaborates with R&D clinical development senior leaders and stakeholders to develop, implement, and continuously improve global and local GCP quality strategies that align with AbbVie R&D pipeline goals and objectives, setting the overall vision and long-term priorities for the Clinical Quality Assurance organization.
This role reports directly to the Vice President of R&D Quality Assurance and is a member of the R&D Quality Leadership Team. There is an expectation that in performance, leadership, and behaviors (AbbVie's Ways We Work), they serve as a role model to the organization at large.
Major Responsibilities:
Develop, implement, and ensure continuous improvement of the clinical quality assurance strategy ensuring compliance with applicable regulations, industry standards, and company polices.
Drive the strategic planning process for the Clinical Quality Assurance organization through ongoing assessment of regulatory, industry, technological, and internal trends/best practices, determining impact to the business.
Drive effective and efficient execution of clinical quality assurance projects/initiatives including associated activities stemming from new project acquisitions, collaborations, mergers/acquisitions, CAPAs, and continuous improvement efforts.
Pioneer industry leading clinical quality assurance techniques and approaches while maintaining compliance and efficiency in related operational processes. Develop strategies to identify and mitigate related risks across GCP activities.
Establish and maintain robust clinical quality standards. Develop and implement standard operating procedures (SOPs), quality manuals, and other related quality documents. Ensure that these systems are effectively communicated, understood, and followed by relevant stakeholders.
Develop and implement clinical quality risk management strategies to identify, assess, and mitigate risks associated with clinical operations. This involves conducting risk assessments, developing risk mitigation plans, and overseeing their implementation.
Consult and partner with the R&D Quality Internal Audit team to ensure appropriate focus areas of clinical operations, including investigator sites, vendors, and internal processes. Support regulatory inspections, ensuring preparedness and appropriate responses to findings and observations.
Provide leadership and oversight for training programs related to clinical quality assurance. Ensure that employees and relevant stakeholders receive appropriate training on quality standards, regulations, and procedures.
Evolve and chair the Clinical Quality Functional Area review to ensure the review meets its intended purpose and remains current with external/internal requirements including seamless integration with R&D and Executive Management review.
Establish and monitor quality metrics and key performance indicators for the effectiveness of clinical quality assurance activities. Prepare regular reports and presentations for executive management highlighting quality performance, trends, and areas for improvement.
Collaborate with cross-functional teams, including clinical operations, regulatory affairs, pharmacovigilance, and other relevant departments, to ensure alignment and integration of clinical quality assurance activities. Build and maintain effective relationships with internal and external stakeholders, including regulatory agencies and auditors.
Drive a culture of continuous improvement in clinical quality assurance. Identify areas for enhancement, implement process improvements, and promote best practices to enhance an overall culture of quality, efficiency, and compliance.
Evolve, develop, lead, guide, and mentor a growing geographical dispersed clinical quality assurance team, responsible for the execution and sustainability of GCP across the R&D clinical trial/study portfolio. Set clear expectations, manage performance, and foster a positive collaborative working environment for a geographically diverse team located around the world. Develop talent and build a skilled motivated team.
Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
-
Senior Manager Quality Assurance
1 month ago
North Chicago, Illinois, United States AbbVie Full timeJob Description Purpose Responsible for quality of assigned products which includes combination products and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Responsibilities Maintains the...
-
Specialist, Distribution Quality Assurance
1 month ago
North Chicago, Illinois, United States AbbVie Full timeJob Description Purpose Assure compliance with FDA current Good manufacturing Practices (cGMP) and Good Distribution Practices (cGDP) regulations. Assure compliance with Corporate policies/procedures and provide guidance on operational processes, procedural issues and documentation content and adequacy. Assess operations/distribution outages and...
-
Director, Regulatory and Quality Assurance
2 weeks ago
Chicago, United States Ann & Robert H. Lurie Children's Hospital of Chicago Full timeOf Position Responsibility: The Director, Regulatory & Quality Assurance, assumes a critical role in the research enterprise at Stanley Manne Childrens Research Institute by ensuring investigators and study teams have the knowledge and tools to cond Quality Assurance, Director, Clinical Research, Regulatory, Quality, Operations, Technology, Healthcare
-
VP, Medical Strategy
6 days ago
Chicago, Illinois, United States EVERSANA INTOUCH Full timeJob Description WHAT DOES A VP, MEDICAL STRATEGY DO? Head of the Medical team on a large network affiliate comprising brands in multiple disease states across a range of clients including Marketing, Medical Communications, Medical Affairs, and Market Access Provide strategic and scientific direction to Medical, Creative, Account and Planning teams for the...
-
Senior Manager Quality Assurance
5 days ago
North Chicago, United States AbbVie Full timeJob Description A variety of soft skills and experience may be required for the following role Please ensure you check the overview below carefully.PurposeResponsible for quality of assigned products which includes combination products and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring...
-
Manager, Quality Assurance
2 weeks ago
North Chicago, Illinois, United States AbbVie Full timeJob Description Responsibilities Defines strategy for staff to manage daily activities for planning and implementing the LRP. Manages direct reports including hiring, setting performance expectations, reviewing performance and developing staff to support the Quality needs of the plant. Evaluates and develops tools to enable staff to continually improve...
-
Quality Assurance
14 hours ago
North Highlands, United States WestCare Foundation Full timeQuality Assurance Job Details Job Location North Highlands 4616 Roseville Road - North Highlands, CA Position Type Full Time Education Level High School Salary Range $22.58 - $22.58 Hourly Job Category Nonprofit - Social Services Description POSITION SUMMARY: Person in this position will be responsible for assisting the Contract Compliance...
-
Manager, Quality Assurance
3 days ago
North Chicago, United States AbbVie Full timeCompany 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...
-
Software Quality Assurance Engineer
3 days ago
North Chicago, United States Beacon Hill Full timeMy Pharmaceutical Client is actively seeking a Software Quality Assurance Consultant to support their North Chicago based team. Years of experience/education and/or certifications required: 6+ yrs as a software Test Engineer. Good to have ISTQB Certification.What are the top 3-5 skills requirements should this person have?Hands-on experience and strong...
-
Software Quality Assurance Engineer
3 days ago
North Chicago, United States Beacon Hill Full timeMy Pharmaceutical Client is actively seeking a Software Quality Assurance Consultant to support their North Chicago based team. Years of experience/education and/or certifications required: 6+ yrs as a software Test Engineer. Good to have ISTQB Certification.What are the top 3-5 skills requirements should this person have?Hands-on experience and strong...
-
Software Quality Assurance Engineer
3 days ago
North Chicago, United States Beacon Hill Full timeMy Pharmaceutical Client is actively seeking a Software Quality Assurance Consultant to support their North Chicago based team. Years of experience/education and/or certifications required: 6+ yrs as a software Test Engineer. Good to have ISTQB Certification.What are the top 3-5 skills requirements should this person have?Hands-on experience and strong...
-
Director, QA Strategy
4 weeks ago
North Chicago, Illinois, United States AbbVie Full timeJob Description Purpose The Director, QA Strategy, is responsible for developing and implementing long-term plans and goals for the Quality Assurance organization. This role will lead our strategic planning and execution, provide individual leadership and consulting services for high-complexity transformational business programs in close collaboration with...
-
Quality Assurance Supervisor
4 weeks ago
Chicago, United States Promo Builder Full timeThe role of the Quality Assurance Supervisor is to lead the Quality Assurance team and directly support and contribute to the Customer Experience strategy and customer centric culture. The role communicates and delivers work to align the Company's mission, vision and culture in all elements of customer experience.Our ideal candidate is an articulate,...
-
Quality Assurance Supervisor
1 month ago
Chicago, United States Promo Builder LLC Full timeJob DescriptionJob Description The role of the Quality Assurance Supervisor is to lead the Quality Assurance team and directly support and contribute to the Customer Experience strategy and customer centric culture. The role communicates and delivers work to align the Company’s mission, vision and culture in all elements of customer experience.Our ideal...
-
Chicago, Illinois, United States Starcom Full timeJob Description Starcom is a world-renowned media agency that delivers meaningful brand experiences. Starcom helps get the right consumers’ attention and creates brand-building results for many of the world's leading companies. Our people are transformational, dynamic, relentless, and fearless experts. We seek out and develop these attributes in our...
-
Director of Quality
6 days ago
Chicago, United States RUSH University Medical Center Full time**Location**:Chicago, IL **Hospital**:RUSH University Medical Center **Department**:General Surgery Transplant MSP **Work Type**:Full Time (Total FTE between 0. 9 and 1. 0) **Shift: Shift 1** **Work Schedule**:8 Hr (8:00:00 AM - 5:00:00 PM) - HYBRID WORK OPPORTUNITY* Summary: The Director of Quality and Operations reports to the Vice President Rush...
-
Quality Assurance Manager
2 weeks ago
Chicago, United States Grnalbuquerque Full timeQuality Assurance Manager Hoffmann Estates, IL Required Experience: 5+ years working in a GLP regulated environment 5+ years working in a GLP regulated environment Supervisory/Management experience preferred Required Education: Bachelor’s Degree (M.S. degree preferred) Job Description The Quality Assurance Manager is responsible for coordinating Global...
-
Quality Assurance Analyst
4 weeks ago
Chicago, United States Atechstar Full timeResponsibilities Test Execution Execute manual and automated tests including functional regression integration and performance testing to identify defects and ensure software meets specified requirements. Test Automation Enhance and maintain test automation frameworks and scripts to increase efficiency and effectiveness of testing processes. Defect...
-
Quality Assurance Analyst
4 weeks ago
Chicago, Illinois, United States Atechstar Full timeResponsibilities Test Execution Execute manual and automated tests including functional regression integration and performance testing to identify defects and ensure software meets specified requirements. Test Automation Enhance and maintain test automation frameworks and scripts to increase efficiency and effectiveness of testing processes. Defect...
-
Quality Assurance Manager
1 day ago
Chicago, United States The Timken Company Full timeJoin Timken and Make What's Next Possible What Timken makes possible begins with you. Those who came before us helped land a man on the moon, create the world's infrastructure, and introduce renewable energy alternatives. Now you can join the Timken team to write your own unique story and help drive what's next. A career at Timken means you can have an...
