The Manager of Quality & Compliance (Q&C) reports into the Director of Q&C for AbbVie Patient Services (APS). This role is responsible for overseeing and improving upon established compliance and quality system processes associated with patient support programs (area of focus will be access & reimbursement). 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 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.
Assist with internal and external audit management for internal, supplier and vendor assessments, help maintain standard audit process and documentation, conduct internal operational audits, and help create audit reporting and metrics.
Assist with remediation plans for control weaknesses or gaps identified. Responsible for proactively identifying potential noncompliance before occurrence.
Influence key patient service business leads to implement quality & compliance programs and controls as the access and reimbursement business compliance SME.
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.
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 the creation of a continuous improvement culture that results in simplification and gained efficiencies throughout the business.
Become a Change Management Methodology SME and support the implementation and use of CM tools throughout APS as required throughout our intake and demand process.
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 engaging existing AbbVie Patient Services partners, identifying new partners, providing awareness to key programs, set expectations, influence decisions, and maintain good relationships. 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. This role has responsibility for the performance and results strategically important functions.
- Position requires BS degree in a science related area.
- Work experience in the pharmaceutical industry, patient services and/or access & reimbursement preferred.
- 5+ years of Quality Systems experience within the pharmaceutical industry with some leadership experience and a demonstrated understanding of relevant regulations and standard operating procedures.
- 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, 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.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 5 % of the Time
Job Type: Experienced