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Senior Manager, eQMS Technologies

AbbVie

This is a Contract position in South San Francisco, CA posted December 31, 2022.

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 systems Lead/support continuous quality improvement activities including analytical and metric tools Qualifications: 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 At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients.

As an equal opportunity and affirmative action employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

If you would like to view a copy of the company’s affirmative action plan or policy statement, please email CorpJat_ABVabbvie.com .