Senior Manager, Quality Systems & Platform Compliance

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 . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

Job Description

The Senior Manager of Quality System will report to the Director of Operations, Quality and Compliance within the Strategic Operations function of AbbVie Patient Services. This role is responsible for supporting the established Quality Management System, including Training, Document Management Systems, Quality Processes utilized across our patient support programs. In addition, this role will have BSO responsibilities of the Quality & Compliance Platform (GxP) housed by approved third party to ensure innovation, advancement of capabilities, reporting needs and alignment with functional program owners while ensuring SLC and Data Protection and Privacy enforcement.

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 vendor, functional teams 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.
• Business System Owner of GxP approved third-party housed quality & compliance platform and ensuring the following (but not limited to):
• Strategic oversight of third-party and all approved modules/sleeves of operations that are live, implemented and used within APS.
• Driving implementation of innovation, enhancements of BAU capabilities to meet the needs of functional partners.
• Ensuring data quality, reporting accuracies per capabilities to ensure D2D use of platform and information is accurate, compliant and meets Abbvie compliance and privacy framework.
• Ensuring platform is approved and has all appropriate and up to date documentation (i.e. ADCT, SET, ACTOR, TPSE, etc.)
• Collaborating with functional partners to translate needs into new capabilities that are user friendly and meet established business requirements.
• Ensure rigor of business requirements, testing and roll-out of current and new features.
• Holding approved third party vendor accountable to established MSA, SOW and KPI through defined health checks, including published agendas and meeting minutes.
• 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.

Qualifications

• Bachelor's degree required 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. 
• 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 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. 

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 short-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. 

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. 

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