Senior Risk Management Leader
4 days ago
- Lead as the SOX/FDA/EUMDR/CLIA/CAP/GMP/ISO Compliance subject matter expert working with IT, FP&A, Labs, Cybersecurity and cross-functional process owners to help achieve ongoing design, reviewing, testing, improving, and remediating the IT systems controls for regulatory compliance such as SOX, CLIA, CAP, FDA, EUMDR, ISO, GxP, etc.
- Update and align IT processes, systems, controls, and policies to industry's standard and drive remediation efforts for any identified deficiencies.
- Maintain and enhance SOX controls documentation so they reflect the current environment and would comply with SOX compliance, including testing documentation and systems diagrams.
In addition to these responsibilities, you will also conduct risk-based internal audits to determine soundness, adequacy, and application of IT and controls including identifying control weaknesses, exceptions, and deficiencies in operations.
-
Supply Chain Management Leader
3 weeks ago
Brisbane, California, United States Tempest Therapeutics Full timeJob Title: Supply Chain Management LeaderWe are seeking an experienced Supply Chain Management Leader to join our team at Tempest Therapeutics. This role will play a critical part in ensuring the timely and efficient delivery of clinical supplies for our clinical trial programs.The successful candidate will oversee clinical supply chain activities, from...
-
Brisbane, California, United States CareDx, Inc. Full timeAs a key member of our team, you will play a critical role in protecting our organization's sensitive data and systems from cyber threats. With a strong background in information security and a passion for staying ahead of emerging threats, you will be responsible for designing and implementing robust security measures to safeguard our cloud and network...
-
Thought Leader Liaison Lead
2 weeks ago
Brisbane, California, United States Vera Therapeutics Full timeJob SummaryVera Therapeutics is a late-stage biotechnology company focused on developing treatments for serious immunological diseases.We are looking for a Senior Director, Thought Leader Liaisons to join our team and lead the development and execution of our thought leader engagement strategy.This role will be responsible for building and managing a...
-
Compliance Risk Manager
4 days ago
Brisbane, California, United States CareDx, Inc. Full timeCareDx, Inc. is a leading provider of genomics-based information for transplant patients, and we are seeking an accomplished Sr Manager, SOX and IT Compliance to oversee internal controls over all SOX/FDA/EUMDR/CLIA/CAP/GMP/ISO in scope systems.This role involves coordinating SOX-ITGC and other IT regulatory compliance related activities with systems owners,...
-
Revenue Cycle Management Leader
2 days ago
Brisbane, California, United States CareDx, Inc. Full timeJob OverviewCareDx, Inc. is a leading precision medicine solutions company focused on developing clinically differentiated healthcare solutions for transplant patients and caregivers.This role is based in Brisbane, California, and requires the candidate to be on-site at least 3 days per week.The estimated salary for this position is around $140,000 -...
-
Biotechnology Quality Management Leader
3 weeks ago
Brisbane, California, United States Vera Therapeutics Full timeOverviewVera Therapeutics is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Our mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients.About the RoleWe are seeking a highly experienced Vice President, Quality to lead our...
-
Brisbane, California, United States Xaira Therapeutics Full timeAbout Xaira TherapeuticsXaira Therapeutics is a forward-thinking organization dedicated to harnessing the power of computational biology and bioinformatics. We believe that by combining cutting-edge technology with innovative research, we can make a significant impact in the life sciences space.Job SummaryWe are seeking an experienced Senior Computational...
-
Compliance Risk Management Specialist
4 days ago
Brisbane, California, United States CareDx, Inc. Full timeAbout the Role:CareDx, Inc. is a leading provider of precision medicine solutions for transplant patients and caregivers. As a Sr Manager, SOX and IT Compliance, you will be responsible for overseeing internal controls over all SOX/FDA/EUMDR/CLIA/CAP/GMP/ISO in scope systems, IT policies, procedures, change, and project management for the company.This role...
-
Senior Communications Strategist
4 weeks ago
Brisbane, California, United States Vera Therapeutics Full timeCorporate Communications LeaderVera Therapeutics, a late-stage biotechnology company, seeks an experienced Senior Communications Strategist to shape and execute its communication strategy.About Vera Therapeutics:Vera Therapeutics is committed to developing treatments for serious immunological diseases. Our mission is to advance treatments that target the...
-
Technical Business Enablement Leader
6 days ago
Brisbane, California, United States BioSpace, Inc. Full time**BioSpace, Inc.: A Pioneer in Life Sciences Technology**We are a leading innovator in the life sciences industry, dedicated to delivering cutting-edge technology solutions that drive business growth and success. Our team is comprised of experts who share a passion for harnessing the power of technology to transform industries.**Job Description:**We are...
-
Executive Assistant to Senior Leadership
4 weeks ago
Brisbane, California, United States Vera Therapeutics Full timeAbout Vera TherapeuticsVera Therapeutics Inc. is a clinical-stage biotechnology company dedicated to developing innovative biologic therapeutics with transformative clinical potential.We are passionate about advancing treatments that target the source of immunologic diseases, aiming to change the standard of care for patients.Our lead product candidate,...
-
Program Development Manager
4 weeks ago
Brisbane, California, United States Freenome Full timeTransform Cancer Detection with FreenomeFreenome is a pioneering biotech company dedicated to developing innovative tests for cancer detection using standard blood draws. Our multiomics platform combines tumor and non-tumor signals with machine learning to identify cancer in its earliest, most treatable stages.We are driven by a relentless pursuit to save...
-
Senior Manager of Product Life Cycle
2 weeks ago
Brisbane, California, United States Freenome Full timeFreenome is a high-growth biotech company developing innovative solutions to detect cancer earlier and more effectively. As our Senior Manager of Product Life Cycle, you will be responsible for leading the development of IVDs and interacting with FDA regulators/reviewers.We're seeking an experienced program manager with at least five years of experience in...
-
Regulatory CMC Senior Manager Opportunity
4 weeks ago
Brisbane, California, United States Vera Therapeutics Full timeVera Therapeutics is a biotechnology company dedicated to developing treatments for serious immunological diseases.We are seeking a skilled Senior Manager, Regulatory CMC to join our fast-paced and collaborative team. This role will involve working with cross-functional teams to lead and support regulatory submissions and activities in the US and...
-
Brisbane, California, United States Vera Therapeutics Full timeJob SummaryWe are looking for a seasoned Regulatory Submission Specialist Senior Manager to lead the preparation of regulatory submission documents in compliance with global regulatory requirements. As a key member of our Regulatory Operations and Regulatory Affairs teams, you will support cross-functional departments and ensure timely and high-quality...
-
Senior Procurement Manager for Strategic Sourcing
19 hours ago
Brisbane, California, United States LHH Recruitment Solutions Full timeOverview of the RoleIn this exciting opportunity, we are seeking a seasoned Senior Procurement Manager to lead our strategic sourcing efforts. With a strong background in procurement management and contract negotiation, you will oversee the acquisition of goods, services, and contracts for our organization.About the JobThis is a Monday to Friday role with a...
-
Brisbane, California, United States Freenome Full timeAbout the RoleFreenome is seeking a highly skilled Senior Systems Integration Engineer to join our Product Development team. In this role, you will provide technical leadership and contribute to the development of next-generation NGS assays/products for early cancer detection.In this position, you will define the strategy and architecture to build fully...
-
Commercial HR Strategy Leader
2 weeks ago
Brisbane, California, United States Vera Therapeutics Full timeResponsibilitiesPartner with Commercial leaders to develop and implement HR strategies aligned with business objectives.Leverage complex data and people analytics to provide critical insights into talent trends and inform business decisions.Manage employee relations issues, ensuring legal compliance and maintaining effective working relationships with...
-
Senior Manager, Regulatory CMC Lead
4 weeks ago
Brisbane, California, United States Vera Therapeutics Full timeCompany Overview: Vera Therapeutics is a late-stage biotechnology company dedicated to developing treatments for serious immunological diseases. Our mission is to advance innovative therapies that target the root causes of these conditions, ultimately changing the standard of care for patients. With a focus on immunologic diseases, we are committed to making...
-
IT Compliance Specialist
4 days ago
Brisbane, California, United States CareDx, Inc. Full timeOverviewCareDx, Inc. is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers.We are seeking an accomplished and dynamic Sr Manager, SOX and IT Compliance (governance, risk, and compliance) subject matter...