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 Sr Manager/Associate Director, Quality Management System (QMS) who is responsible for the implementation and efficient management of quality management systems (QMS) to various US and international regulatory requirements for IVDs and medical devices such as FDA QSR (21 CFR 820), ISO 13485 and MDSAP, in continued alignment with the existing laboratory QMS for LDTs (CLIA/CAP, NYSDOH).
- Responsible for the implementation and efficient management of quality management systems (QMS) to various US and international regulatory requirements for IVDs and medical devices, such as FDA QSR (21 CFR 820), ISO 13485 and MDSAP (EU and beyond)
- Responsible for the continued alignment with laboratory QMS for LDTs, to requirements such as CLIA/CAP, NYSDOH and GCLP
- Leading quality systems team responsible for various QMS activities such as CAPAs, complaints, non-conformances, audits, training, production and process controls, material/purchasing/supplier controls, facility and equipment controls, document, record and change control
- Ensuring audit readiness: Aligning and preparing various cross-functional teams (such as R&D, operations, business/customer alliances, clinical, lab and IT) for regulatory inspections (e.g. US FDA, ISO 13485/EU Notified Bodies) and customer/partner audits (e.g. pharma)
- Develop quality metrics across all QMS processes, and implement data-driven approach to quality management
- Apply quality management best practices and innovation - not bound to traditional and one-size-fits-all approaches - to ensure QMS is built around value-based and efficient principles in ensuring regulatory compliance
- Work closely with cross-functional stakeholders to ensure QMS incorporates the organizational needs and those of internal (as much as external and regulatory) customers, is closely integrated with the business processes, and is aligned with the technological needs
- Perform other related duties and responsibilities as assigned
- Bachelor and/or advanced degree in a life science discipline
- At least 10 years experience in quality management systems in the FDA regulated domain - IVDs or medical device
- QMS experience in some combination of a diagnostic manufacturing organization (IVDs) and molecular testing laboratory (LDTs)
- Experience within QMS implementation, and developing new quality policies and procedures.
- Experience with CDx (Companion Diagnostics) technologies a plus
- Experience with NGS (Next-Gen Sequencing) technologies a plus
- Experience with GCP (Good Clinical Practices) QMS requirements a plus
- Excellent organizational, interpersonal, verbal and written communication skills