质量运营项目主管
Quality Operations Program Manager
维瓦系统是一个以使命为导向的组织,也是行业云领域的先驱,帮助生命科学公司更快地将治疗带到患者。作为历史上增长最快的 SaaS 公司之一,我们在过去财年收入超过了30亿美元,未来有着广泛的增长潜力。维瓦核心是我们的价值观:做正确的事情,客户成功,员工成功和速度。我们不仅只是任何公开公司。我们通过成为公共利益公司 (PBC) 在2021年创造历史,法律上必须平衡客户,员工,社会和投资者的兴趣。作为 Work Anywhere 公司,我们支持你在家或办公室工作的灵活性,以便你可以在理想环境中繁荣。加入我们改变生命科学行业,致力于对客户,员工和社区产生积极影响。角色质量运营计划经理作用确保了维瓦在质量管理系统 (QMS) 中的过程的完整性,合规性和管理。作为文件控制的进程主管,这一职能确保了多个产品线和受监管领域中的流程定义,监控,评估和维持。#LI-Remote #LI-Associate 维瓦公司总部位于旧金山湾区,在全球15多个国家设有办事处。维瓦是一家平等机会雇主。所有合格申请人将获得就业考虑不论种族,颜色,性别,性取向,性别身份或表达,宗教,民族起源或祖先,年龄,残疾,家庭状态,怀孕,受保护的退伍军人的地位,受保护遗传信息,政治属性或任何其他受到当地法律,法规或条例保护的特征。如果你需要帮助或住宿,因为残疾或特殊需求在申请职位或招聘过程中,请联系我们:talent_accommodations@veeva.com. What You Will Do · Act as a subject expert for the Document Control process area by owning the creation and lifecycle management of quality processes and records · 提供监管的质量监督,例如程序定义,验证测试和产品发布/变化范围中的产品和系统 · 提供技术专业知识,法规解释和有关联邦规定和其他质量体系要求的指导
查看英文原文
Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last fiscal year with extensive growth potential ahead.
At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors.
As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment.
Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities.
The Role
The Quality Operations Program Manager role ensures the integrity, compliance, and management of Veeva’s processes within the Quality Management System (QMS). Serving as a process owner for document control, this role ensures processes are defined, monitored, assessed, and maintained across multiple product lines and regulated domains.
#LI-Remote
#LI-Associate
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.
What You'll Do
- Act as a subject matter expert for the Document Control process area by owning the creation and lifecycle management of quality processes and records
- Provide quality oversight on regulated activities and deliverables, such as process definition, validation testing, and product releases/changes for in scope products and systems
- Provide technical expertise, regulatory interpretation, and direction regarding federal regulations, and other quality system requirements
- Develop appropriate metrics and track effectiveness and productivity of applicable domain systems
Requirements
- BS/BA in Science, Information Management, Engineering, related disciplines or equivalent industry experience
- 3+ years experience in a regulated quality role in Life Sciences
- Experience with Quality Management Systems (e.g., documentation and record management, training, change control, CAPA)
- Experience with electronic Document Management Systems (eDMS) and/or electronic Quality Management Systems (eQMS)
- Good understanding of GxP (GMP, GCP, etc.) regulations, principles of quality management systems in a regulated environment (21CFR 11, ICH Q10, QSR) and/or quality frameworks such as ISO9001
- Excellent process mapping, problem-solving, and communication skills to effectively convey technical and regulatory concepts
Nice to Have
- Direct, hands-on experience with Veeva Quality Cloud solutions (e.g., Veeva QualityDocs, QMS, or Training)
- Solid foundation in Quality Principles and Standards used in the design, development, testing, and maintenance of software in a regulated environment (e.g., ISO, IEC, IEEE, ITIL, ICH)
- Understanding of the software development cycle (SDLC) and computer systems validation (CSV)
Interviewing with Veeva
We value your time and believe in a transparent hiring process. Here is the process you can expect.
- Follow the application process and submit your resume.
- Within 3 days, you will receive a link to a personality assessment administered by a third party.
- Once you complete the assessment, our team will review your full application package and follow up via email with our decision.
- If moving to the interview stage, the process is as follows:
- A conversation with the hiring manager
- A practical case exercise
- A final conversation with our group's Senior Leader.
- Once all interviews are complete, the manager will be in touch with a final decision.
Perks & Benefits
- Medical, dental, vision, and basic life insurance
- Flexible PTO and company paid holidays
- Retirement programs
- 1% charitable giving program
Compensation
- Base pay: $85,000 - $130,000
- The salary range listed here has been provided to comply with local regulations and represents a potential base salary range for this role. Please note that actual salaries may vary within the range above or below, depending on experience and location. We look at compensation for each individual and base our offer on your unique qualifications, experience, and expected contributions. This position may also be eligible for other types of compensation in addition to base salary, such as variable bonus and/or stock bonus.