Senior Manager, Quality Systems & Process Compliance

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.
• 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.
• Position requires 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.
• 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 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.
• Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
• 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, c

Benefits

Additional Information

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.

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