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Quality Engineering Compliance Manager - Seattle

  • Job
    Full-time
    Senior Level
  • Software Engineering
  • Seattle
  • Quick Apply

AI generated summary

  • You must have 6+ years of experience in software development engineering, knowledge of FDA/EU regulations, and a Bachelor’s degree in CS or related field. Experience in building quality programs and navigating the product life cycle is a must.
  • You will develop and maintain QMS, change management systems, run client meetings, audit tests, ensure system qualifications, author procedures, nurture relationships, advocate for quality, and support customer enablement at Palantir Technologies.

Requirements

  • 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.

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.

FAQs

What is the main focus of this role as a Quality Engineering Compliance Manager at Palantir Technologies?

The main focus of this role is to support Palantir's rapidly growing life sciences business by building and improving the GxP Quality Management System (QMS) framework, ensuring regulatory compliance, and driving improvements to quality systems and processes through a software quality engineering lens.

Technology
Industry
1001-5000
Employees
2003
Founded Year

Mission & Purpose

At Palantir (NYSE: PLTR), we're helping the world's most important institutions use their data to solve their most urgent problems. Our software lets our customers integrate and analyze all of their data so they can answer questions that they couldn't before. From delivering disaster relief to building safer automobiles, we're honored to help make our partners better at their most important work. Together with our customers, we're building the future of national security, healthcare, energy, finance, manufacturing, and more. And we need bright minds from around the world to help us.