Manager, Quality & Compliance

AbbVie Inc.; Mettawa (IL); On-site; USD 110,000 - 209,000; Full time

Job summary

AbbVie Inc. is seeking a Manager of Quality & Compliance to oversee and enhance quality systems across patient support programs, including OneHUB.

You will lead audits, monitor KPIs, and drive continuous improvement while partnering with cross-functional teams to ensure regulatory adherence and superior patient outcomes. The role emphasizes change management, CAPA, training, and metrics with a focus on strategic risk management and collaboration among Commercial, Legal, and Global Patient

Qualifications

• BS degree in a science related area; Master’s degree preferred.
• 5+ years of compliance or Quality Systems experience with leadership.
• Located in Lake County, Illinois with 3-day in-office requirement.
• Strong organizational, strategic thinking, analytical and reporting skills.
• In-depth understanding of pharmaceutical patient centricity, customer service, and quality systems.
• Excellent verbal, written, presentation and interpersonal skills.
• Willing to travel up to 10-15% domestically.

Responsibilities

• Assist with internal and external audit management and remediation oversight.
• Collaborate with OneHUB team on monitoring activities for responsible functions.
• Develop and monitor quality metrics and KPIs across major areas.
• Influence business leads to implement quality & compliance programs as SME.
• Oversee development and maintenance of quality programs and procedures.
• Support continuous improvement and integrate quality systems into projects and reviews.
• Build cross-functional relationships to manage risk and ensure end-to-end quality.

Skills

Leadership

Audit management

Quality systems

Regulatory compliance

Stakeholder management

Data analysis & storytelling

Presentation skills

Travel up to 15%

Education

Bachelor's degree in a science related field

Master’s degree preferred

Tools

PowerPoint

Analytics tools

Job description

• Compensation: USD 109,500 - USD 208,500 - yearly

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

Job Description

The Manager of Quality & Compliance (Q&C) reports into the Associate Director of Q&C for AbbVie Patient Services. This role is responsible for overseeing and improving upon established compliance and quality system processes associated with patient support programs, with the primary functional area of responsibility including OneHUB support. This person should be familiar with quality management system processes (CAPA, Training, Audits, Metrics and Monitoring) as well as change management, process mapping and continuous improvement tools. This role will support the implementation of the Patient Services Q&C Roadmap. This role is also responsible to maintain a culture of excellence to ensure a superior experience for partners and patients that will deliver desired outcomes and enable timely, informed decisions.

Responsibilities:

• Assist with internal and external audit management for internal, supplier and vendor assessments, and help maintain standard audit process and documentation including remediation oversight as needed.
• Collaborate with the OneHUB team on oversight of all monitoring activities for functional areas of responsibility.
• Assist with remediation plans for control weaknesses or gaps identified. Responsible for proactively identifying potential noncompliance before occurrence.
• Develop and monitor appropriate quality metrics for review by management including inputs into the management review process. Includes the identification and establishment of critical key performance indicators/metrics across all major areas to monitor the health of our systems.
• Assist in the Influence of key patient service business leads to implement quality & compliance programs and controls as the OneHUB Q&C SME.
• Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Support a continuous improvement culture that results in simplification and gained efficiencies throughout the business.
• Operate as a key leader in our quality efforts and be the champion of establishing the environment of continuous improvement. Work to integrate the quality system into all that we do, including project management, metrics, and performance review process.
• Stakeholder Management: Build cross-functional relationships to ensure end to end quality and manage risk.
• Responsible for cultivating relationships with existing Q&C business and governing partners, identifying new partners, providing awareness to key programs, setting expectations, and help influence decisions. Increase awareness and knowledge within the business on quality standards and expectations.
• Liaison and Relationship Building: Builds collaborative relationships. Interacts well with diverse groups across business and technology functions and maintains strong working relationships with internal and external collaborators.
• Culture: Consistently demonstrate AbbVie's Ways of Working and Leadership Attributes including an enterprise mindset and people leadership. Understand and execute AbbVie's vision, goals, and strategies.

Qualifications

• Position requires BS degree in a science related area. Master’s degree and work experience in the pharmaceutical industry preferred.
• 5+ years of compliance or Quality Systems experience with some leadership experience and a demonstrated understanding of relevant regulations and standard operating procedures.
• This role requires the candidate to be physically located in Lake County, Illinois and adhere to 3-day in office ways of working.
• This role requires strong organizational, strategic thinking, analytical and reporting skills, and strong understanding of the patient services and pharmaceutical business.
• Requires an in-depth understanding of the pharmaceutical patient centricity, customer service oriented, and quality systems.
• The position requires human relations and administrative skills necessary to establish and maintain effective working relationships with team members, co-leaders, and senior leadership in Commercial, Business Technology Services, Legal, OEC, Privacy, Manufacturing Operations, Global Medical Affairs, Promotions, Brand teams, and Global Patient Services.
• The individual must possess sound judgment in evaluating and establishing compliance strategic plans as well as in day-to-day situations.
• Conflict resolution skills including persuasive management techniques required. Excellent data creation, storytelling, power point and analytics skills.
• Excellent verbal, written, presentation and interpersonal skills required.
• Ability to communicate concepts and problems in terms that are understandable to all levels of the organization, including senior leadership.
• Must be willing to travel up to 10-15% domestically.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• 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 posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin 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 toparticipatein our long-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 employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s 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.