Senior Manager Quality Assurance, Regulatory Compliance 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 Manager/Sr Manager - Quality System and Regulatory Compliance who will
- Implement and maintain Quality Management System (QMS) as per the requirements of FDA QSR (21 CFR 820), ISO 13485 and other applicable regulatory requirements, as well as best practices in quality management.
- Support and improve compliance status of various QMS activities.
- Lead eQMS implementation across multiple QMS activities.
- Oversee regulatory compliance activities including conducting internal audits, ensuring inspection readiness, and hosting external inspections.
This role’s primary responsibility is to support the organization’s mission of maintaining regulatory compliance while ensuring business goals of efficiently bringing new innovations and products to market, and reports to the Vice President of Quality Assurance.
- Continued implementation and maintenance of medical device/IVD QMS (ISO 13485/FDA QSR) - in harmonization with LDT (CLIA/CAP) QMS including GCLP (Good Clinical Lab Practices):
- Responsible for evaluating and implementing company compliance with all applicable domestic and international standards and regulations.
- Responsible for actively monitoring the regulatory landscape including updates and changes.
- QMS procedures: Develop new or edit existing QMS documentation and SOPs for adherence to these standards and regulations.
- Identify Quality Initiatives and lead cross-functional teams to complete them.
- Establish strong connection and collaboration with business partners cross-functionally, e.g. Quality, Regulatory, R&D, Engineering, Supply Chain and Operations for this purpose.
- Adopt a proactive approach to regulatory compliance while incorporating best practices in quality management in each domain.
- Support and improve compliance status of various QMS activities:
- Oversee or support QMS activities across multiple domains, such as CLIA/CAP, GCLP/GCP, ISO 13485 and FDA regulated environments.
- Support QMS activities such as CAPA, NCR, deviation, issue and complaint management.
- Support Post Market Surveillance activities, recalls, corrections, and medical device reporting.
- Review technical data and quality metrics across all areas to ensure compliance standards are met; identify opportunities for improvement and take action as necessary.
- Prepare materials for management reviews, and present as needed.
- Complete training on medical device standards, regulations, and company QMS procedures to the staff as required.
- Supports the supplier quality program.
- Mentor and develop Quality personnel, specialists and engineers.
- Complete QMS inquiries and questionnaires from potential customers/partners.
- Lead eQMS implementation across multiple QMS activities:
- Lead implementation of eQMS (eTQ) modules such as complaints, supplier, audits, CAPA, NCRs, and others.
- Lead the required workflow improvements (including defect resolution and reconfigurations) of eTQ modules already implemented such as Doc Control, Change Control, training and eMDR.
- Support the ongoing maintenance of eQMS/eTQ.
- Works autonomously with the external vendor, as well as internal cross-functional stakeholders and SMEs for this purpose.
- Regulatory compliance activities:
- Ensure audit readiness for external audits - regulatory agencies/FDA PAI, notified body/ISO 13485, and pharma partners. Act as a change leader, responsible for execution of major readiness and compliance initiatives.
- Oversee and facilitate such external audits, including drafting audit responses.
- Work with area management to address audit findings, drive opportunities for improvement and address potential gaps/preventive actions.
- Responsible for the internal audit program - conducting internal audits including follow-up activities to closure.
- Conducting supplier audits as necessary.
- Serves as a notified body interface, including switching from one to another.
- Bachelor’s Degree or higher, preferably in Engineering or Science disciplines
- 5+ years in a management capacity
- 8+ years of quality systems and regulatory compliance experience in the FDA regulated environment - medical devices or IVDs.
- Previous experience with hosting external agency inspections.
- Detailed knowledge of FDA Quality System Regulations, ISO 13485:2016, ISO 14971, MDSAP and EU-IVDR.
- Excellent organizational, interpersonal, verbal and written communication skills, with ability to effectively communicate at multiple levels in the organization.
- eQMS experience preferred.
- Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
- Advanced computer skills, including statistical/data analysis and report writing.
- Multitasks, prioritizes and meets deadlines in a timely manner.
- Ability to travel,l approximately 25%.
- RABQSA ISO 13485 lead auditor, ASQ CQA certification preferred.
- Demonstrated ability to operate and innovate in teams with a fast‐paced environment, balancing business, compliance, and strategic needs.