Quality Assurance Project Manager at Tempus
Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
We are looking for a Quality Assurance Project Manager who will lead standardization and implementation of global process improvements that drive product and process quality and compliance across the organization. This role will collaborate with multiple sites and cross-functional stakeholders.
This position will report to the Vice President, Quality Assurance.
- Leads complex projects related to QMS (Quality Management System) and QA activities, including process improvements and operational projects to improve process and product quality.
- Monitors project scope, timeline, and resources to assure project completion on schedule and as per expectations.
- Familiarity with regulatory requirements and best practices in QMS and regulatory compliance.
- Lead small, medium, and large cross-functional and multi-site initiatives to identify, develop, modify, improve, and implement global process solutions for compliant Quality Systems.
- Develop high level reporting strategy and metrics to be reported to enable executive management to take action to improve process and product quality.
- Work with a cross-functional team to implement metric reporting.
- Assisting QA leadership with communication of project status and needs to executive management team members.
- Develop and deliver training content for QMS processes and regulatory compliance.
- Other QMS and QA related duties as assigned.
- Bachelor's degree or equivalent in Biology, Chemistry, or related field.
- 8+ years' experience in a medical device, IVD or pharmaceutical industry, or equivalent combination of education and experience.
- Advanced knowledge of and application of best practices in Quality Systems, Quality Engineering, Quality Assurance, Quality Management, and quality metrics/statistics reporting required.
- Proven ability to collaborate and influence with or without authority, facilitate groups with diverse perspectives and align teams.
- Demonstrated and impactful project management and leadership skills (PMP preferred), including the ability to lead multi-site, cross-functional teams, and resolve quality-related issues in a timely and effective manner.
- Multitasks, prioritizes and meets deadlines in a timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Solid communication and interpersonal skills, with ability to effectively communicate at multiple levels in the organization.
- Knowledge of FDA Quality System Regulation (QSR), GMP, ISO 13485:2016, ISO 14971, MDSAP and EU-IVDR is a plus.
- eQMS experience is a plus.
- Previous experience with external/regulatory agency audits/inspections.
- Ability to travel as required.