Senior Manager, Quality Systems & Platform Compliance
AbbVie
2 months ago
Remote friendly (Mettawa, IL)
United States
Operations
Responsibilities:
- Champion process and continuous improvement; integrate quality into APS including project management, metrics, and performance review processes.
- Translate APS policies, procedures, and approved processes into organizational training plans within approved LMS (ALC, Compliance Wire, LERN).
- Own the annual APS training plan; lead collaborative governance meetings with the US Commercial Compliance Training team; ensure functional areas/PSP program owners are assigned training and enforce on-time completion.
- Own PSP Experience and Insights process; stand up agile/efficient dashboards, reports, and templated processes for functional areas and APS.
- Own Quality PSP AI-based processes (e.g., QS autoscoring, call summaries, transcriptions); oversee framework/reporting and continuously improve capabilities; liaise between third-party vendor, functional teams, and BTS partners.
- Oversee development and maintenance of quality programs/systems/processes/procedures that ensure compliance and support D2D operational business and program owners; ensure good documentation practice and knowledge management.
- Business System Owner of GxP approved third-party housed quality & compliance platform, including:
- Strategic oversight of live/implemented modules/sleeves used within APS.
- Drive innovation and BAU enhancements to meet functional partner needs.
- Ensure data quality and reporting accuracy; support compliant use and alignment with AbbVie compliance/privacy framework.
- Ensure platform approval and up-to-date documentation (e.g., ADCT, SET, ACTOR, TPSE).
- Collaborate with functional partners to translate needs into user-friendly capabilities meeting business requirements.
- Ensure rigor of business requirements, testing, and rollout of current/new features.
- Hold third-party vendor accountable to MSA/SOW/KPI via defined health checks (including published agendas and meeting minutes).
- Coordinate with operations, quality & compliance teams to ensure delivery of data/metrics for performance read-outs, calibrations, and management reviews.
Qualifications:
- Bachelor’s degree required in a science-related area.
- 5+ years of Quality Systems experience in the pharmaceutical industry, with some leadership experience; demonstrated understanding of relevant regulations and standard operating procedures.
- Strong organizational, strategic thinking, analytical, and reporting skills; strong understanding of patient services and pharmaceutical business.
- In-depth understanding of pharmaceutical patient centricity, customer service, and quality systems.
- Human relations/administrative skills to maintain effective relationships with team members and senior leadership across Commercial, Business Technology Services, Legal, OEC, Manufacturing Operations, Global Medical Affairs, Promotions, Brand teams, and Global Patient Services.
- Sound judgment in evaluating/establishing compliance strategic plans and day-to-day situations.
- Conflict resolution skills (persuasive management techniques).
- Excellent verbal, written, presentation, and interpersonal skills; ability to communicate concepts/problems to all organizational levels, including senior leadership.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
- Eligible to participate in short-term incentive programs.
- Champion process and continuous improvement; integrate quality into APS including project management, metrics, and performance review processes.
- Translate APS policies, procedures, and approved processes into organizational training plans within approved LMS (ALC, Compliance Wire, LERN).
- Own the annual APS training plan; lead collaborative governance meetings with the US Commercial Compliance Training team; ensure functional areas/PSP program owners are assigned training and enforce on-time completion.
- Own PSP Experience and Insights process; stand up agile/efficient dashboards, reports, and templated processes for functional areas and APS.
- Own Quality PSP AI-based processes (e.g., QS autoscoring, call summaries, transcriptions); oversee framework/reporting and continuously improve capabilities; liaise between third-party vendor, functional teams, and BTS partners.
- Oversee development and maintenance of quality programs/systems/processes/procedures that ensure compliance and support D2D operational business and program owners; ensure good documentation practice and knowledge management.
- Business System Owner of GxP approved third-party housed quality & compliance platform, including:
- Strategic oversight of live/implemented modules/sleeves used within APS.
- Drive innovation and BAU enhancements to meet functional partner needs.
- Ensure data quality and reporting accuracy; support compliant use and alignment with AbbVie compliance/privacy framework.
- Ensure platform approval and up-to-date documentation (e.g., ADCT, SET, ACTOR, TPSE).
- Collaborate with functional partners to translate needs into user-friendly capabilities meeting business requirements.
- Ensure rigor of business requirements, testing, and rollout of current/new features.
- Hold third-party vendor accountable to MSA/SOW/KPI via defined health checks (including published agendas and meeting minutes).
- Coordinate with operations, quality & compliance teams to ensure delivery of data/metrics for performance read-outs, calibrations, and management reviews.
Qualifications:
- Bachelor’s degree required in a science-related area.
- 5+ years of Quality Systems experience in the pharmaceutical industry, with some leadership experience; demonstrated understanding of relevant regulations and standard operating procedures.
- Strong organizational, strategic thinking, analytical, and reporting skills; strong understanding of patient services and pharmaceutical business.
- In-depth understanding of pharmaceutical patient centricity, customer service, and quality systems.
- Human relations/administrative skills to maintain effective relationships with team members and senior leadership across Commercial, Business Technology Services, Legal, OEC, Manufacturing Operations, Global Medical Affairs, Promotions, Brand teams, and Global Patient Services.
- Sound judgment in evaluating/establishing compliance strategic plans and day-to-day situations.
- Conflict resolution skills (persuasive management techniques).
- Excellent verbal, written, presentation, and interpersonal skills; ability to communicate concepts/problems to all organizational levels, including senior leadership.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
- Eligible to participate in short-term incentive programs.