CMC QA Senior Manager: Global Quality & Change Control
Scorpion Therapeutics
Scorpion Therapeutics is seeking a Senior Manager, CMC QA to oversee Product Complaints, Annual Product Quality Review, and Change Control Review Board programs within biopharmaceutical manufacturing, ensuring GxP compliance. The role leads global quality review processes, supports product release, investigates complaints, and represents the organization during regulatory inspections. Hybrid work with 2-3 onsite days weekly and up to 10% travel. #J-18808-Ljbffr Scorpion Therapeutics
- What You’ll DoThe Senior Quality Assurance Specialist... ...assurance oversight across CMC development, Quality Control, Analytical... ...ensuring compliance with global regulatory... ...deviations, CAPAs, and change controls.• Identify... ...of Quality Management System (QMS) processes...SeniorFull timeContract workImmediate start
$160k - $175k
...to apply for the Sr. QA Manager role at Piper Companies... ...Companies is seeking a Senior Quality Assurance Manager to... ...System (QMS) complies with global standards, including... ...Manufacturing (CMC) Quality Assurance Senior... ...Manager, QA Document Control & Training Topsfield,...SeniorFull time$154.4k - $242.55k
...DescriptionJoin Takeda as a Senior/Principal... ...a consultant to management and an external spokesperson... ..., and analytical control strategy. You will... ...on project teams, CMC sub-teams, and... ...Development, Quality Control, contract... ...comparability, manufacturing changes, and lifecycle...SeniorMinimum wageContract workTemporary workLocal area$200k - $240k
Cambridge, MATechnical Operations - Quality Control /Full-Time /On-siteScholar Rock is a late-stage global biopharmaceutical company... ..., specification lifecycle management, analytical method lifecycle activities... ...QC support for post-approval changes, regulatory commitments, and...SuggestedFull timeContract work$200k - $260k
...seeking a Director/Senior Director, GMP Quality Assurance... ...goods within a global outsourced manufacturing... ...selection and management, process... ...demand. Lead QA input into CDMO... ...investigations, CAPAs, change control, batch review, CPV... ...closely with CMC, Technical Operations...SeniorContract workTemporary workFlexible hours$89.9k - $141.24k
...DescriptionJoin Takeda as a Senior Research Associate,... ...development, quality control readiness, method... ...deliverables for CMC programs. You will... ...leadership or people management responsibilities. How... ...grow through life-changing work.Certified as a Global Top Employer,...SeniorMinimum wageTemporary workLocal areaShift work$240k - $285k
...LinkedIn and Facebook.Role Summary:The Senior Director, Quality Control leads the strategy and execution... ..., and product lifecycle management. This role ensures global GMP compliance, inspection readiness... ...activities, including change controls, corrective and preventive...SeniorContract workLocal area- ...to the Director, R&D Quality, the Sr. Manager, R&D Quality is responsible... ..., Quality issues, Change controls, and Risk... ...communicate quality metrics to senior leadershipEnsure... ...3), FDA regulations, global requirements, and GxP... ...record of success in R&D QA in the biotech/pharmaceutical...SeniorTemporary workWork at officeLocal areaImmediate start3 days per week
$160k - $200k
...Director, GMP Quality Assurance Operations... ...with global regulatory requirements... ...to the Senior Director, Quality... ...and execute GMP QA activities for... ...audits, QTA, issue management and performance... ...investigations, CAPA’s, change control, batch review,... ...closely with CMC, Technical...Work at officeRemote work$148k - $180k
...officePosition Summary: The Senior Quality Operations Manager provides day-to-day... ...Analytical Development, Quality Control, and Regulatory Affairs to... ..., investigations, change controls, CAPAs, and effectiveness... ...systems, and applicable global regulationsExperience with...SeniorFull timeContract workFlexible hours2 days per week3 days per week$210k - $320k
...efficient single base changes, at targeted... ...Director / Director of CMC, to lead our... ...ensure the integrated control strategy is... ...status reporting, risk management, escalation and resolution... ...Development and Quality Control.Develop... ...CMC sections for global regulatory...SeniorFull time$121k - $172k
...programs.Provide senior-level review... ...performance and quality of deliverables... ...resolution of issues.Manage a portfolio of... ...with CMC, Quality Assurance... ...troubleshooting, and quality control programs,... ...USP, and other global regulatory... ...bringing life-changing therapies to patients...SeniorContract workShift work$191.25k - $260k
Overview Make a global impact—join Repligen. We’re... ...innovative and life-changing therapies in the world... .... Join us! As Senior Director, Quality, you will provide strategic... ...a robust Quality Management System that meets regulatory... ...Validation, Quality Control, Supplier Quality...SeniorWorldwideFlexible hours- ...advances Harvard's world-changing mission in meaningful... ...products.This position manages the design, the implementation... ...and delivery of QA processes, programs and... ...infrastructure servers.Quality Assurance design and executionReview... ...in QA, achieving a senior level of responsibility...SeniorFor contractors
- ...growing sectors in the global energy economy,... ...and experienced Quality Assurance Team Lead... ...of the quality management system (QMS) and establishing... ...processes and controls in cell and... .../Quality Control (QA/QC) capabilities as... ...document control, change management, corrective...Work at officeFlexible hours
- What You’ll DoThe Manager, Quality Control leads daily operations of the analytical testing laboratory... ...and Preventive Actions), and change controls effectively.• Serve as a primary... ...workflows.• Deep understanding of FDA/global regulatory guidance on handling OOS test...Full timeImmediate start
$136k - $221k
...experts working across our global operations in 35... ...& Health, Energy, and Management Consulting. We invite... ...creating sustainable change that benefits society... ...clear and concise manner.Quality Control and Assurance:Implement... ...ConsultingExperience level: Mid-Senior LevelIndustry:...SeniorFull timeLocal area$127.9k - $191.8k
...outside of the organization.Your Role:The Global Labeling Excellence Lead is responsible... ...labeling activities within Regulatory Quality Safety (RQS). This role partners... ...established continuous improvement and change-management methodologies to improve ways of working...SeniorLocal areaImmediate start$195k - $330k
...and execution of global regulatory CMC strategies for degrader... ...closely with CMC, Quality, Non-Clinical, and... ...CMC guidance to senior leadership... ...product development, control strategy, and lifecycle management.Demonstrated success... ...and post-approval change management.Excellent...Senior$110.6 per hour
...Description Aspen Publishing is seeking a Manager of Testing & Psychometrics to be a... ...and test blueprints, determining when changes are warranted, in collaboration with... ...and document best practices Ensure quality control processes for project deliverables Engage...Work experience placementWork at officeRemote workWork from home$110.6k - $146.5k
...based expertise, our global minds unite to... ...permitting, and risk management.Support business... ...Independently deliver quality work in a deadline... ....Provide senior technical review of... ...providing quality control of client deliverables... ...may be subject to change for business purposes...SeniorLocal areaRemote workFlexible hours$210k - $300k
...Biomedicines is seeking a Senior Director,... ...lifecycle management, release and stability... ...with the QA team to review... ...events, CAPAs, change controls, health authority... ...partner to CMC, Process Development, MS&T, Quality, Regulatory, Supply... ...with global regulatory expectations...SeniorContract workShift work$172k - $287k
..., delivering life-changing science to enable... ...Clinical Research, Senior Principal Scientist... ...out and lifecycle management. Develop and... ...Pharmacovigilance, CMC, Translational... ...scientific thinking, high-quality decision-making... ...knowledge of global clinical development...SeniorFull timeLocal area2 days per week3 days per week$170k - $218k
...Director of Quality AssuranceThe Director... ...oversee GMP QA operations for... ...electronic Quality Management System (eQMS)... ...based document control and archiving... ...EMA, and other global regulatory inspections... ...including Change Control,... ...functional teams and senior leadership.Demonstrated...Contract work$132k - $198k
Global Pre-Sales Engineering Operations ManagerAbout MimecastThe work people build is worth... ...Global Pre-Sales Engineering Operations Manager to build the operating backbone behind... ..., translating roadmap and launch-tiering changes into enablement needs and helping address...SeniorFull timeLocal areaRemote workWorldwide$212k - $333.19k
...shine? Join us as a Senior Director, Global Program Lead-... ...potential through life-changing work. Certified as... ...sense of the time/quality balance. Provides matrix management, strategic and... ...Pharmaceutical Sciences (CMC) Subteam, etc. to... ...; monitor and control expenditures; manages...SeniorMinimum wageTemporary workWork at officeLocal areaRemote work- Job Overview:The Global Senior Director, HR serves as the strategic HR Business Partner for the Global Supply... ...direction across organizational design, talent management, succession planning, capability development, change management, and workforce planning to ensure the...SeniorLocal area
- Director, Quality Control (QC) Location: Cambridge, MA (Hybrid... .... Grow, mentor, and manage QC staff across... ...and raw materials under global GMP standards. Oversee... ...assessments, deviations, CAPAs, change controls, and... ...Collaboration Partner with CMC, Process Development,...
$250k - $273k
The Senior Director, Quality Compliance is responsible for providing... ...the organization’s global quality compliance... ...global supplier quality management program for CMOs,... ...deviations, CAPAs, change control, and quality metrics... ...regions.Collaborate with CMC, Regulatory Affairs,...SeniorWork at officeRemote work$173k - $285.33k
...Do As a Director/Senior Director, CMC Drug Substance Development... .... Lead and Manage Team Execution : Lead... ..., select, and manage global external partners for... ...analytical development, Quality Assurance, and CMC... ...and adapt quickly to changing circumstances. Team...Senior
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