Associate Director, QA Computer System Validation
Scorpion Therapeutics
Responsibilities Provide leadership and oversight for implementation of GxP computer system validation lifecycle and related QA-CSV/CSA strategies Support CSV/CSA functional strategies and multi-year roadmap; help develop strategy Lead internal and contract resources to manage CSV/CSA activities Participate in global/enterprise GxP-CSV/CSA projects and validation working groups Manage risk assessments with functional teams; develop mitigations Provide input to CSV/CSA documentation and oversee execution of qualification/validation activities Review and approve qualification/validation documentation (specifications, protocols, risk assessments, reports) Participate in vendor assessments/audits; manage/lead routine and complex CSV/CSA audits Provide CSV/CSA compliance guidance and support continuous improvement Prepare for CSV/CSA inspections and support regulatory agency inspections Update/create computer system policies, procedures, templates, forms Provide validation approach guidance to project teams for regulatory compliance Lead new system selection (requirements gathering, RFP development, vendor selection) Develop/evaluate quality processes and system standards for compliance Identify and implement process improvements Review/approve computer system SOPs, change controls, deviations, and CAPAs Qualifications Bachelor’s degree in engineering, science, or equivalent; 10+ years in QA, CSV/qualification, or related areas Experience with Veeva Vault eQMS, Veeva eTMF, CTMS, Medidata Rave, SAS, TraceLink, Oracle Fusion In-depth knowledge of CFR 21 Part 11, GAMP5, Annex 11, and data integrity Strong knowledge of EMA, MHRA, FDA and other regulations; GCP, GVP, GMP, GDP, GLP Detail-oriented; able to manage multiple projects independently Experience authoring/reviewing/approving validation documentation In-depth SDLC knowledge; validation practices for configurable, non-configurable, and off-the-shelf software Data migration experience; vendor audit experience Strong decision-making, critical thinking, and communication/interpersonal skills with cross-functional teams #J-18808-Ljbffr Scorpion Therapeutics
- Under minimal supervision, the Associate Director of Quality carries out the... ...data needed and data validation for assigned projects in collaboration... ...committees. Leadership and Systems Thinking Demonstrates... ...and CMS is preferred. Computer/Software Skills & Abilities...ComputerWork experience placementWork at office
$165k - $231k
About the Role As the Associate Director, Enterprise Applications - Digital & Marketing Systems, you will serve as a strategic technology leader responsible for identifying... .... Factors for Success Bachelor’s degree in computer science, Information Systems, Engineering,...ComputerLocal areaRemote work$10,618 per month
Associate Director, Custodial Services & Climate Control Systems Job Summary The Associate Director of Custodial Services and Climate Control Systems provides strategic... ..., or other multi‑facility complex. License A valid driver's license is required for this position....Suggested- Overview Associate Director of Managed Care Informatics and Data Management... ...operational reports, performing system support, analysis, and... ...involved with creating and validating reliable data. The Associate... ...visualization tools a plus Computer/Software Skills & Abilities...ComputerFull timeWork at officeLocal areaMonday to FridayFlexible hoursAfternoon shift
- ...Department. Serve on the Athletic Director’s executive leadership team... ...department area heads and associated staff in the areas of... ...Skill in the use of personal computers and related software applications... ...develop and maintain recordkeeping systems and procedures. Ability to...ComputerWork at officeNight shiftWeekend workAfternoon shift
$170k - $200k
...Position: Director of Information Systems Pay Range: $170,000-$200,000 PER YR Reporting To: VP of Finance Work Type: Hybrid/Full Time POSITION SUMMARY... ...degree in Information Systems, Business Administration, Computer Science, or a related field required. 7+ years of...ComputerFull timeLibertana
California, MO1 day ago- Position: Director, Quality Systems Responsibilities Provide governance and oversight of the Quality Management System... ...workflows, reporting). Lead and support validation activities for GxP computerized systems (Computer System Validation (CSV) and Computer Software...ComputerRemote workFlexible hours
- Title: Quality Control Validation Specialist Location: Thousand Oaks, California Job Description Analytical method validation/ transfer... ...& utilities at biopharmaceutical manufacture plant. Computer system validation protocols and reports, including SCADA and MES. QC...ComputerWork at office
$165k - $230k
The Associate Director of Operational Procurement plays a pivotal role in ensuring the efficient... ...compliance with company policies, procurement systems and practices, and legal requirements... ...be able to remain stationary and use a computer or other standard office equipment,...ComputerContract workTemporary workWork at officeLocal area$130k
...Management approach—moving beyond post-activity QA checks to proactively partnering with the... ...leadership when needed Support quality‑related system work as needed, including contributing to computer system validation activities (e.g., user requirements, risk assessments...ComputerShift workHirebridge
California, MO2 days ago$136k - $212.75k
...Co is looking for a Senior High-Speed IO Validation Engineer to join their hardware product... ..., and USB, as well as debugging complex system-level issues. The ideal candidate should... ...possess a BS in Electrical Engineering or Computer Engineering and have a minimum of 3...Computer- ...operations and team performance. The Associate Director of Manufacturing will provide both strategic... ...documentation and quality systems activities including batch records, SOPs... ...deviations, CAPAs, change controls, and validation support. Partner cross‑functionally with...Permanent employment
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...Position Associate Director, Processing Operations Location CARTS – Fresno, CA Reports To Director... ...ROI analysis for capital investments, system upgrades, and new processing technologies... ...and professional development. Valid driver's license with acceptable driving...Temporary workLocal areaNight shiftWeekend workCaglia Environmental
California, MO2 days ago- ...Manufacturing Co is seeking a Lead Post-Silicon Validation Engineer to join their GPU Engineering... ...involves managing and validating memory system for next-generation GPUs for various... ...a strong background in electrical or computer engineering with over 12 years of relevant...Computer
- Scorpion Therapeutics is seeking an experienced professional for a leadership role in QA and Computer System Validation (CSV) in California, Missouri. This position requires oversight of GxP management and validation strategies, ensuring compliance in quality assurance...Computer
- ...Quality Assurance Specialist - Validation Hunter Healthcare are... ...they are seeking experienced QA professional to play a key role... ...maintaining and enhancing quality systems, ensuring the highest... ...documentation. Review and approve Computer System Validation (CSV) documentation...ComputerWork at office
Hunter Healthcare
California, MO4 days ago - ...administration requiring a bachelor's degree in Management Information Systems or Computer Science and several years of related experience. The role... ...operating systems and connectivity for departments. A valid California Driver's License is required. The position encourages...Computer
- ...Matrix is looking for a Senior Staff Runtime Systems Engineer to join our team. This hybrid... ...for the architecture, development, and validation of runtime software for AI inference.... ...candidate possesses a Bachelor's degree in computer or electrical engineering and at least 7...Computer3 days per week
$2,500 per month
...addressing the behaviors and deficits commonly associated with autism. With locations throughout... ...paced, changing environment Excellent computer skills and knowledge of MS Excel, Word, Outlook; ability to use new computer systems and iPads Desire to continuously learn and...ComputerLocal areaRemote workRelocation packageFlexible hours$121k - $205k
## Principal Quality Systems SpecialistApplyremote type: On-Sitelocations: Northridge, California, United States of Americatime... ...with Audit Backroom and/or Front Room roles, non-product computer system validation, regulations/standards assessment, translation...ComputerWork at officeLocal areaWorldwideFlexible hours- ...engineer to help design and operate high-volume, distributed backend systems . This role focuses on data ingestion, asynchronous processing,... ...architectures. Education Bachelor’s or Master’s degree in Computer Science, Engineering, or a related technical field. Experience...Computer
$69k - $129k
...100 King Street West Job Overview The Associate Director supports the growth and risk‑management... ...timely and accurate data entry into BMO’s systems and leverage the data to support... ...A recruiting agency must first have a valid, written, and fully executed agency agreement...Contract workWork experience placementWork at office$168k - $258.75k
NVIDIA’s System Product Team is looking for curious, collaborative, and motivated hardware... ...‑on leadership of HBM/GDDR enablement, validation, and failure analysis for NVIDIA’s... ...knowledge of Linux, scripting, programming, computer systems, and data analysis methods. Your...Computer- The Associate Territory Manager Surgical supports and reports to the Director of Sales in the coverage and set up of Surgical cases in... ...experience is a plus Must have a valid driver’s license in one of the... ...proper phone etiquette Computer skills - Microsoft Word, Excel...ComputerLocal area
$103.1k - $147.2k
## Associate Director, Business & Legal AffairsApplylocations: NA / Hollywood N Orange Dr 37.5time type: Full timeposted on: Posted Todayjob... ..., diverse assignments* Strong time management skills* Computer literacy (MS Word & Excel essential)**What We Give You:*** You...ComputerWork at office$168k - $264.5k
NVIDIA has been transforming computer graphics, PC gaming, and accelerated computing for... ...NVIDIA is seeking passionate Senior Silicon Validation Engineers to validate the world’s... ...Work multi-functionally with ASIC, SW, System, Characterization and ATE teams to accomplish...Computer- ...preservation technology associated with a particular food... ...government/quality systems standards Participate... ...report findings to the QA team Keep records of all... ...Other Qualifications Computer Literacy: Proficient in... ...include documentation validating the equivalency of the...ComputerImmediate startFlexible hoursShift work
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California, MO2 days ago $96k - $106k
...or an alternative application process. Computer Systems Analyst III Regular Full-Time NAS North... ...the following: Network interfaces and associated equipment Communications (fiber‑optic,... ...DOD network security training. Possess a valid state Driver’s License. Must possess and...ComputerFull timeWork at officeVETS
California, MO4 days ago$132k - $207k
...Artificial Intelligence, High-Performance Computing and Visualization. The GPU, our... ...manufacturing test solutions for Datacenter system products at NVIDIA. What you’ll be doing... ...solutions for Data Center products. Setup, validate and support rack level tester platforms...ComputerContract workDormont Manufacturing Company
California, MO3 days ago$80k - $89k
...Computer Systems Analyst I Regular Full-Time NAS North Island, CA Salary Range: $80,000.00 To... ...the following: Network interfaces and associated equipment Communications (fiber-optic,... ...DOD network security training. Possess a valid state Driver’s License. Must possess and...ComputerFull timeWork at officeVeteran Enterprise Technology Services , LLC
California, MO4 days ago
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