The RoleThe Quality Operations Program Manager role ensures the integrity, compliance, and management of Veeva's processes within the Quality Management System (QMS). Serving as the process owner for document control, this role ensures processes are defined, monitored, assessed, and maintained across multiple product lines and regulated domains. This role also serves as system administrator for electronic Document Management System (eDMS) ensuring the delivered system aligns with quality and company goals.
What You'll Do - Act as subject matter expert for the Document Control process area by owning the lifecycle management of quality processes and records
- Serve as System Administrator of Veeva's internal electronic Document Management System (eDMS), responsible for system configuration, user administration, lifecycle management, and continuous improvement of the system and its governed processes
- 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
- 5+ 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 utilizing or administering 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)
Perks & Benefits - Medical, dental, vision, and basic life insurance
- Flexible PTO and company paid holidays
- Retirement programs
- 1% charitable giving program
Compensation - Base pay: $100,000 - $150,000
- 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.
#LI-RemoteUS #LI-AssociateVeeva's headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.
Work Where It's Best for You Work Anywhere means you can work in an office or at home on any given day. It's about getting the work done in the way and place that works best for each person. This applies across all locations and departments.
Work Anywhere does not mean work at any time. We have predictable core hours where employees are generally available for meetings and collaboration. Employees are focused and available during core hours.
We invest in our offices to make them places where our employees like to go. If you work in the office three or more days a week, you will have a dedicated office workspace. Our offices function as hubs to draw people in, create social bonds, and where random connections and mixing of ideas happen. We're investing more in offices, culture, and offsite meetings, not less.
Product teams are organized in regional product hubs for optimal collaboration and live within a time zone of their hub. Our current product hubs are located in Pleasanton, Columbus, Boston, Kansas City, New York City, Raleigh, and Toronto. We create opportunities for teams to get together in person regularly.
Customer-facing roles, such as Sales and Professional Services, live near and/or travel to their customers.
When an employee moves within a country it does not cause a change in salary. Where you live impacts you and your family. Not knowing if your compensation will change if you move can cause stress and uncertainty for everyone. We wanted to eliminate that.
Work at Veeva. Work where it's best for you.
