It's a fantastic time to be part of the Compliance team at Box. We're looking to hire a QMS/Validation Manager to be part of the team to maintain Box's quality initiatives in a fast-paced technology environment.
You will be part of the team overseeing the maintenance of Box’s Quality Management System (QMS) in accordance with GAMP 5 standards and ISO 9001:2015, ensuring Box's products and services meet our customer's compliance requirements. You be part of the team to drive communication and education to Box's internal and external customers. The QMS/Validation Manager will be based at Box's headquarters in Redwood City, CA.
Why the team needs you
We have an experienced compliance team today, but are growing to keep up with our customer demand as well as both maintain and expand our certifications. We're a tightly knit team and expect you to be a team player who helps out wherever needed. We'd love to add someone to the team that is has experiences in the pharma/ life sciences industry and is a team player willing to take on new challenges. Your skills and knowledge from the pharma/ life sciences industry is a plus to help the companies of the regulated industry to work together as one using Box.
Why you need Box
Box is growing real fast. Every business in the world is looking to modernize the way that they work. As the leader in cloud content management, Box is the only company that can help enterprises transform how people work together. As companies around the world and in regulated industries move to Box they need to ensure that we are meeting their regulatory requirements.
We're not your average Compliance team. We engage with our customers and work daily with our Security, Operations and Engineering teams to ensure we are doing the right things and push boundaries. Our goal is to build and maintain a world class compliance program so that our customer's can focus on their mission and business rather than compliance.
Who you are
You're excited to work for a company that changes how people think about Compliance. Most of all you have an ability to hustle, get stuff done and stay compliant-make MOM proud! The right person will be comfortable interfacing with people from all levels and functions of the organization, including Compliance, Product, Engineering and the Industries teams at Box. You will be asked to manage the interface between Box, the partner and customers to meet the requirements of a regulated industry for Box platform and to oversee the validation of internal systems, if this is you, please read on!
Here's the fine print:
- Maintain the VAP (validation accelerator package), providing the selected partner with all necessary documentation, test results pertaining to all changes made to both infrastructure and software on a daily basis
- Provide an ongoing interface between Box, the Partner and our Customers using Box for FDA regulated data
- Develop validation plans for new functionality that impacts the validated status of the Box service (major changes to functionality)
- Maintenance of the Validation IQ/OQ Scripts
- Maintain System Documentation such as System Requirements Specification, Functional RequirementsSpecifications, Design SpecificationsMaintain QMS SOPs and responsible for Document Control
- Develop and provide training to all Box personnel who are responsible for adhering to the QMS, Change Management, Validation and VAP process.
- 5+ years of experience in software development, service development and validation, as well as ISO 9001requirements.
- 2+ years experience in an equivalent technology risk-based approach to compliance and auditing.
- Experience in verification and validation (IV&V) steps including DQ, IQ, OQ, and PQ.
- Willingness and ability to travel to domestic and international locations if necessary.