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 dashboards
• 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
• Partner with BTS to drive development of new quality systems and enhancements
• Work with 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 quality systems
• Lead/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 study
• 5-7 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 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
• Travel: 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.

Abb Vie 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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Abb Vie'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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.