Senior Manager, Quality Systems & Process Compliance

AbbVie•Mettawa, IL

16h

About The Position

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. The Senior Manager of Quality System will report to the Director of Compliance and Quality within the Strategic Operations function of AbbVie Patient Services. This role is responsible for supporting leadership to develop and oversee APS PSP governance to ensure compliance and adherence to AbbVie guiding framework and policies. Role builds procedures & processes in alignment with Legal, OEC, Privacy and Regulatory to ensure all PSPs that are launched, modified or sunset are appropriately governed and executed.

Requirements

BS degree in a science related area.
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.
Strong organizational, strategic thinking, analytical and reporting skills, and strong understanding of the patient services and pharmaceutical business.
In-depth understanding of the pharmaceutical patient centricity, customer service oriented, and quality systems.
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.
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 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.

Responsibilities

Be a champion of establishing the environment of process and continuous improvement.
Work to integrate quality into all we do in APS, including project management, metrics and performance review processes.
Translating APS Policies, Procedures and Approved Process into approved organizational training plans within approved LMS (ALC, Compliance Wire, LERN).
Own annual APS training plan and lead collaborative governance meetings with US Commercial Compliance Training team. This includes ensuring functional areas, PSP program owners are appropriately assigned training, and enforcing on-time completion.
Own PSP Experience and Insights process, ensuring agile and efficient dashboard, reports and templated processes are stood up to meet the needs of our functional areas and APS business as whole.
Ownership of Quality PSP AI based process (i.e. QS autoscoring, call summaries, transcriptions, etc.) Includes oversight of current framework, reporting and continuous improvement of capabilities.
Liaison between third-party vendors, functional teams like Platform Enablement and BTS partners to ensure collaboration, strong working relationships and delivery of capabilities.
Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance and can support D2D operational business and program owners. This ensures good documentation practice, as well as continued knowledge management of implemented processes.
Ensuring quality, reporting accuracies per capabilities to ensure D2D use of compliance platform and information is accurate, compliant and meets AbbVie compliance and privacy framework.
Ensuring we create strong repeatable process in support of PSP governance and approvals. For example, but not all inclusive (ADCT, SET, ACTOR, TPSE, POET, etc.)
Collaborating with functional partners to translate needs into new capabilities that are user friendly and meet established business requirements.
Work with operations, quality & compliance team to ensure they are receiving appropriate support to deliver data and metrics related to performance read-outs, calibrations and management reviews.