Quality Engineering Compliance Manager
Palantir Technologies
Core Responsibilities
- Continue to develop a Palantir-wide QMS that lives under ISO 9001 and drives consolidation of process documentation and promotes process consistency at Palantir.
- Develop and maintain a Change Management software system atop Palantir Foundry that is adaptive to client requirements, whilst conforming to developer practices within Palantir.
- Periodically run Change Management meetings with key client POCs demonstrating proactive and retroactive changes to guide changes in client SOPs and trainings for client personnel.
- Support implementation and maintenance of internal software applications and systems supporting QMS processes like Document Management System and Learning Management System.
- Periodically audit developer authored unit and integration tests and work with Product Development teams to ensure maximal code coverage.
- Run Installation Qualification (IQ), Operational Qualification (OQ) and guide Performance Qualification (PQ) of Palantir Foundry system.
- Author and ensure implementation of approved procedures across the organization, setup non-conformance and CAPA processes to monitor deviations and management reporting.
- Establish and nurture inter-departmental relationships to drive key objectives such as socializing SOPs, conducting and enforcing training programs, negotiating release process with product development teams.
- Be the champion and advocate for ingrained quality across Palantir, work with product development and product reliability teams to implement GxP processes.
- Support customer enablement lifecycle, include customer and FDA audits, as well as assessment questionnaires for GxP clients.
What We Value
- A visionary who has no problem getting their hands dirty and doing the work necessary to create and improve the state of the world.
- Experience documenting SOPs and coordinating cross-functionally to maintain adherence to documented process.
- Interest in building and maturing a program, specifically in the quality space (Quality Management System and process areas within a QMS (e.g. Doc Control, Training, Supplier Management CAPA, SDLC, Change Management, etc.)).
- Experience navigating the product life cycle, as well as standard SDLC in a DevOps world.
- Thrives in a fluid, dynamic and fast-paced environment, specifically a modern SaaS company.
- Ability to connect and develop positive relationships with employees across cross-functional teams (Engineering, Compliance, Product Reliability, Product Development, among others).
- Experience in demonstrating value proposition of a quality to internal stakeholders without experience/buy-in.
What We Require
- You have at least 6+ years of relevant work experience.
- Software Development (Test) Engineering experience.
- Knowledge of FDA and EU regulatory requirements and other guidelines related to GxP activities, including 21 CFR Part 11 / GAMP 5, and supporting CSV work a plus.
- Bachelor’s degree in Computer Science, Information Systems, Management Information Systems, or related.
Benefits
- Medical, dental, and vision insurance
- Life and disability coverage
- Paid leave for new parents and emergency back-up care for all parents
- Family planning support, including fertility, adoption, and surrogacy assistance
- Stipend to help with expenses that come with a new child
- Commuter benefits
- Relocation assistance
- Unlimited paid time off
- 2 weeks paid time off built into the end of each year