Quality Specialist Risk Management in Columbus

Job Description

Join American cloud-computing and Software company Veeva Systems, currently hiring Quality Specialist Risk Management in Columbus OH, Apply Veeva careers in Columbus OH.


Position : Quality Specialist Risk Management

Location : Columbus, OH

Job Category : Quality, Security & Compliance


Job Details

Veeva [NYSE: VEEV] is the leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, our customers range from the world’s largest pharmaceutical companies to emerging biotechs. Veeva’s software helps our customers bring medicines and therapies to patients faster.
We are the first public company to become a Public Benefit Corporation. As a PBC, we are committed to making the industries we serve more productive, and we are committed to creating high-quality employment opportunities.
Veeva is a Work Anywhere company which means that you can choose to work in the environment that works best for you – on any given day. Whether you choose to work remotely from home or work in an office – it’s up to you.
Veeva was recently named the #1 Best Place to Work in Central Ohio by Columbus Business First.
The Role
The Quality Specialist Risk Management oversees Quality, Regulatory & Compliance support, and oversight to manage and optimize the robustness and consistency of the Quality Management System (QMS), which is owned by the Risk Management processes to drive operational and quality excellence across Veeva. What You’ll Do Facilitate and monitor Risk Management activities (e.g., FMEA or any other activities as specified in local and/or global procedures). Follows up and tracks implementation of Risk Management action items or project plans. Participates in Risk Management documentation changes and change control activities. Determine and monitor Risk Management key performance indicators (KPIs) and provides support for other functional areas regarding risk metrics. Oversee the deployment of the Risk Management module and processes, determining if a new Risk Management record and Risk Management mitigation plan are required, or if a project should be using an existing Risk Management record for the issue or product. Participate in CAPA (Corrective and Preventative Action) program provides tactical support for daily program operations; open CAPA records as needed, and work with CAPA record owners to complete deliverables on time and provide guidance on proper Root Cause Analysis and documentation. Requirements Bachelor’s degree in life sciences, or other related scientific disciplines, or equivalent relevant industry experience. 3+ years of experience in a regulated industry with at least three (3) years of experience in pharmaceuticals, clinical research, and/or medical device. Prior experience in Risk Management for the life science industry. Knowledge of ICH Q9, ISO, etc. Strong verbal and written communication skills, and engaging culturally diverse groups Prior experience in GxP system changes, validation, and implementation. Nice to Have Knowledge of ICH Q9, ISO 13485, ISO 9001, 21CFR820 Exposure to Agile SDLC, SaaS, and/or IT cloud technologies #LI-RemoteUS
#BI-Remote Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world. Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at talent_accommodations@veeva.com.


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