GxP Audit & Compliance Manager
WHAT IS BOX?
Box is the market leader for Cloud Content Management. Our mission is to power how the world works together. Box is partnering with enterprise organizations to accelerate their digital transformation by creating a single platform for secure content management, collaboration and workflow. We have an amazing opportunity to further establish ourselves as leaders in the space, and we need strong advocates to help us achieve that goal.
By joining Box, you will have the unique opportunity to help capture a majority of this developing market and define what content management looks like for the digital enterprise. Today, Box powers over 97,000 businesses, including 70% of the Fortune 500 who trust Box to manage their content in the cloud.
WHY BOX NEEDS YOU
In the role of GxP Audit & Compliance Manager at Box, you will be responsible for ensuring the continued success of Box's Quality Management Services while leading a high performing team. We're looking for someone to not only maintain the existing programs, but to expand and lead improvements while supporting the business. This role requires a comprehensive understanding of quality programs in a technology compliance landscape and various control frameworks. You will work with all functions of this fast-paced, rapidly changing business, and directly with key stakeholders to drive continuous improvement and communication while providing education with Box's internal and external customers.
The right person will be comfortable explaining Box's compliance posture to both internal and external customers, leading teams, providing technical and creative guidance to technical teams, and passing the baton to finish projects with ease and efficiency. If this is you, please read on!
WHAT YOU'LL DO
- Manage and maintain internal processes supporting the Box GxP Validation service
- Interface between business partners and internal stakeholders to support Box customers with GxP compliance
- Monitor, measure, and review internal GxP processes that impact the quality of the service; communicate gaps to leadership and program manage remediation as necessary
- Accurately and effectively communicate our GxP compliance position and programs to external customers to drive trust and support sales engagement
- Lead external customer quality audits to support GTM efforts and provide assurance to Box customers around Box's compliance posture.
- Develop GxP-related content to scale information to customers, partners, analysts and other industry stakeholders
- Provide guidance on maintaining and continuously improve QMS programs to ensure it meets customer, internal and other regulatory/legal requirements and standards
- Drive improvements in existing processes and develop new innovative and efficient solutions
- Keep up on standards, U.S. and other international regulations/laws, issues, and news with respect to product (service) quality
WHO YOU ARE
- 7+ years experience within a fast-paced technology environment with a focus on GxP, quality management (QMS), and quality audits. Life science industry experience is preferred.
- In-depth understanding of GAMP5 and Computer System Validation (CSV)
- Knowledge of security, quality, and compliance frameworks such as SOC, ISO 27001, ISO 9001, PCI-DSS and NIST 800-53. Experience with 21 CFR Part 11 (Annex 11) and Part 820 requirements a plus
- Familiarity with SaaS business model and agile software development methodology
- Excellent written and verbal communication and presentation skills
- Ability to hustle, juggle multiple priorities, and get stuff done
- Excellent collaborator with strong sense of personal and professional integrity - make mom proud!
- BS degree in Business or Quality Systems or related field is preferred but not required
BENEFITS
- Visit this webpage to check out all of our exciting benefits: https://join.collectivehealth.com/box
EQUAL OPPORTUNITY
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
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