About this role
Purpose
The Senior Manager – eQMS (electronic Quality Management System) Technologies is primarily responsible for quality system activities which include: own and support RDQA, R&D, and Enterprise quality systems and applications, support business driven objectives, and lead project work related to quality system implementation, compliance initiatives, analytical tools, and quality metrics. This position helps ensure that effective quality systems and services are in place across R&D to allow development of high quality, safe and effective products in compliance with global regulatory requirements and applicable policies, processes, and procedures. These objectives support pharmaceuticals, biologics, combination products and medical devices reporting into the Director, eQMS Technologies.
Responsibilities
Business system owner (BSO) of validated and more advanced or enterprise computer systems, applications, and dashboardsReview and approve key technical documentation that ensure the compliance of supported systemsCreate and provide training on supported systemsWork with business partners to ensure the adoption of new systems and continued use of established systemsLead and prioritize remediation efforts for any process or technical system issuesPartner with BTS to drive development of new quality systems and enhancementsWork with internal and external business partners to understand and optimize quality processes that utilize electronic quality management systemsDevelop short-term and long-term strategies that optimize current and future projects.Develop and implement quality metrics that demonstrate the health of supported quality systemsLead/support continuous quality improvement activities including analytical and metric tools Required:
Bachelor’s Degree-required in Pharmacy, Engineering, Computer Science, Business, Chemistry, Biology, Microbiology, or relevant course of study5-7 years of experience in engineering, or quality systems, or business support in a regulated environment.Preferred:Experience implementing computerized QA Systems and/or metric or analytical toolsKnowledge of tools and techniques that can be leveraged into actionable activitiesKnowledge of Risk Management principles to help organization focus on the most impactful activitiesQuality Systems knowledge and related experienceTravel: Yes, 10 % of the Time 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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