Associate Director, eQMS Technologies
Associate Director, eQMS Technologies
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Salary Not Disclosed
1 Vacancy
Job Description
Purpose
The Associate Director 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 AI and other data-driven functionality support business driven objectives and lead project work related to quality system implementation compliance initiatives AI analytical tools and quality metrics. This position helps ensure that effective quality systems and services are in place across R&D to allow the 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 data/AI systems
*Review and approve key technical documentation that ensure the compliance of supported systems
*Create and provide training on supported systems
*Work with business partners to ensure the adoption of new systems and continued use of established systems
*Lead and prioritize remediation efforts for any process or technical system issues
*Work and influence internal and external business partners to understand and optimize quality processes that utilize electronic quality management systems
*Develop short-term and long-term strategies that optimize current and future projects.
*Develop and implement quality metrics that demonstrate the health of supported systems
*Lead/support continuous quality improvement activities including analytical and metric tools
*Sponsor technical projects and provide strategic guidance
*Interacts with senior management to recommend technical solutions and analytics for RDQA processes.
*May manage people
This is a hybrid role onsite at our Lake County IL headquarters.
Qualifications :
Required:
*Bachelors Degree-required in Pharmacy Engineering Computer Science Business Chemistry Biology Microbiology or relevant course of study
*8-10 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 tools
*Knowledge of tools and techniques that can be leveraged into actionable activities
*Knowledge of Risk Management principles to help organization focus on the most impactful activities
*Quality Systems knowledge and related experience
*Knowledge of the clinical development for pharmaceuticals and/or medical devices.
Travel: Yes 10 % of the Time
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.
This job is eligible to participate in our long-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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Employment Type
Full-time
