Manager, Quality & Compliance

About the role

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 & Requirements

• 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 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 long-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 Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.