Senior Director, Software Quality & Regulatory Compliance
$205.1k - $307.7kIllumina
A leading genomic technology firm in San Diego is seeking a Sr. Director Software Quality to establish and lead a standalone Software Quality function. This role involves defining the quality management system for software products, driving compliance with regulations, and integrating quality standards across product development. Candidates should have over 20 years of experience in software quality within the medical device industry and a deep understanding of IEC 62304 and SaMD frameworks. The estimated salary range is $205,100 - $307,700, dependent on various factors. #J-18808-Ljbffr Illumina
$210k - $270k
...treatments to patients and families who need them most. The Senior Director, Quality Assurance & Quality Systems provides strategic and... ...Quality Management System (QMS) to ensure sustained regulatory compliance, inspection readiness, and robust quality oversight across...SeniorRegulatoryWork at office$205.1k - $307.7k
...driven applications, the regulatory and quality requirements governing software have become as... ...physical devices. IEC 62304 compliance, SaMD classification, EU... ...regulatory risks. The Sr Director, Software Quality will... ...Operate as a senior quality leader • Serve...SeniorRegulatoryLocal area- A leading consulting firm located in San Diego is looking for a Quality Assurance Senior Specialist to support clinical trial projects. You will ensure compliance with regulatory requirements, lead deviation investigations, and validate testing methods. The ideal candidate...SeniorRegulatory
$133k - $166k
...lives of others. Position Summary: The Senior Manager, Quality Assurance GCP will support the Good Clinical... ...and oversee assigned audits, support regulatory inspections, and support the quality oversight and compliance program at Crinetics Pharmaceuticals. Essential...SeniorRegulatoryLocal area$200k - $240k
A biopharmaceutical company in San Diego seeks a Director Quality Assurance to lead multi-national Quality Assurance for infectious disease... ...with regulations like FDA and GMP, and ensures successful regulatory submissions. Required qualifications include at least 10 years...SeniorRegulatory$210k - $270k
...leading biotechnology company in San Diego is seeking a Senior Director of Quality Assurance & Quality Systems to provide strategic... ...includes overseeing the Quality Management System to ensure regulatory compliance, managing quality for clinical and commercial operations...SeniorRegulatory- ...Senior Director, Quality Ratings & Network Performance About the Company Established organization assisting migrants with... ...Senior Director will also be tasked with ensuring compliance with state and federal regulatory requirements, and will play a key role in the...SeniorRegulatory
- A leading defense technology firm in San Diego seeks a Senior Director of Quality to provide executive leadership across multiple sites, ensuring compliance with quality management systems and continuous improvement. The ideal candidate will have 15+ years of experience...Senior
- Werfenlife SA. in San Diego is seeking a Senior Quality Systems Specialist II to lead the Quality Management System in compliance with regulatory requirements. The candidate will work closely with cross-functional teams and support quality initiatives. With a minimum of...SeniorRegulatory
- Werfen is seeking a Senior Quality Systems Specialist II in San Diego, California, responsible... ...System (QMS) processes to comply with regulatory standards such as GMP, FDA, and ISO.... ...along with supporting regulatory compliance initiatives across departments. A bachelor...SeniorRegulatory
- Ignite Human Capital is seeking a Quality Systems Engineer in San Diego, California. This role is crucial in maintaining the Quality Management System in compliance with regulatory requirements like ISO 13485 and FDA standards. The ideal candidate will have strong leadership...SeniorRegulatory
- Irvine Company is seeking a Senior Director, Project Management, to lead the San Diego regional team in overseeing property... ...operational excellence through project efficiency, quality control, and regulatory compliance. The ideal candidate will have significant...SeniorRegulatory
$200k - $240k
Overview The Director Quality Assurance provides strategic and operational leadership for Quality... ...global quality systems that ensure compliance with FDA, ICH, GLP, GCP, and GMP... ...Working closely with executive leadership, Regulatory Affairs, Shionogi Quality partners, CMOs...RegulatoryFull timeContract workLocal area$189.6k - $284.4k
...Overview: The Director, New Product... ...Introduction (NPI), Design Quality Assurance, is... ...systems, software, hardware, digital... ...programs meet global regulatory requirements, internal... ...) completion and compliance. This position... .... Serve as a senior subject matter...RegulatoryWork at office- A leading pharmaceutical company in San Diego seeks a Senior Manager for Clinical Data Management. This role will handle external data management activities, ensuring data quality and regulatory compliance. Candidates must possess an MS/BS in a relevant field and have 8...SeniorRegulatoryRemote job
- ...Director, Quality Engineering page is loaded## Director, Quality Engineeringremote type: Remotelocations: Remotetime type: Full timeposted... ...to ensure product quality, patient safety, and sustained regulatory compliance.As the enterprise lead for Quality Risk Management (QRM)...RegulatoryContract workWorldwide
$149k - $248.3k
Dexcom is seeking a Senior Manager of Software Quality Engineering in San Diego, California. This role encompasses leading software quality assurance and ensuring compliance with regulatory standards. With at least 7 years of experience in software QA and 5 years in leadership...SeniorRegulatoryRemote job$168.51k - $261.61k
...to more applications world-wide than any other company. Senior Director Quality Job Summary The Senior Quality Director provides executive... ...continually improve a multi-site QMS to ensure consistent compliance with AS9100D/ISO 9001, customer contractual requirements,...SeniorContract workWork experience placementLocal areaFlexible hours- ...is seeking an experienced QA Consultant (GxP) to enhance Quality Systems. The role involves overseeing Quality Management Systems... ...(QMS), managing GxP quality processes, and ensuring compliance with regulatory standards. Ideal candidates will have over 8 years of QA experience...SeniorRegulatory
$135k - $165k
Werfen in San Diego is looking for a Staff Quality Engineer to ensure compliance and excellence in IVD and medical device products. In this individual... ...quality management systems, support audits, and ensure regulatory compliance. This role offers a competitive salary range...SeniorRegulatory- ...Senior Data Integrity Consultant A leading biotechnology company is seeking... ...environment. This role will provide Quality oversight of computerized systems, ensuring... ...data accuracy, security, and compliance with global regulatory standards to support cell and gene therapy...SeniorRegulatoryLocal areaShift work
- ...and life sciences, is looking for a " Senior Data Integrity Consultant " based... ...environment. And, you will provide Quality oversight for computerized systems,... ...and paper-based processes to ensure compliance with FDA and EU regulatory requirements. Responsibilities...SeniorRegulatoryLong term contract
- ...and life sciences, is looking for a " Senior Computer System Validation (CSV)... ...Validation program. This role provides Quality Assurance oversight for computerized... ..., and quality operations, ensuring compliance with global regulatory standards. Reporting to the Site Quality...SeniorRegulatoryLong term contract
- ...Clinical Level of Experience : Senior Level Employment Type :... ...file documentation and regulatory reporting decision activities... ...product for investigation per quality system requirements In concert... ...of QA, Regulatory/Quality Compliance in a medical device industry...SeniorRegulatoryContract workDay shift
$125k - $130k
Simply Biotech is seeking a Quality Manager for their San Diego office. This role oversees quality assurance and control, ensuring compliance with cGMP and regulatory requirements. Candidates should have a Bachelor’s degree in a scientific discipline and over 5 years of...SeniorRegulatoryWork at office$85.12k - $95.76k
...Sr. Compliance Specialist The Sr. Compliance Specialist supports... ...ensure adherence to applicable regulatory requirements and company... ...effectiveness tracking, and supports Quality Management System (QMS)... ...with QMS data management software such as Master Control, Track...SeniorRegulatoryFull timeFlexible hoursWeekend work$86.4k - $135.1k
A life sciences company in San Diego is seeking a Quality Assurance Specialist 3 to ensure compliance and operational excellence. In this role, you will drive quality initiatives and maintain Quality Management Systems (QMS) according to state and federal regulations. Candidates...SeniorRegulatory- ...Position Title: Senior Data Integrity Consultant (GxP) Work Location... ...Position Summary: The Quality organization is seeking an... ...the Quality System satisfies compliance requirements associated with:... ..., and Quality Compliance. Regulatory Knowledge * Expert understanding...SeniorRegulatoryWork at officeLocal area
- ...knowledge and experience 10+ years Quality Assurance experience in a GMP... ...data and potential quality/compliance concerns escalating to... ...defendable interpretations of regulatory guidance for the customer and... ...Services (CSS) Quality Assurance Senior Specialist supports clinical...SeniorRegulatory
- ...performance of infusion platforms. Ideal candidates will have over 10 years of experience in R&D, with a strong emphasis on regulatory compliance and cross-functional collaboration. Join a dynamic team dedicated to transforming healthcare and making the impossible possible...SeniorRegulatory
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