Remote Global Clinical Quality Director - GCP & Inspections
Scorpion Therapeutics
- Remote job
Takeda is seeking a Senior Clinical Quality Assurance Lead to oversee global clinical research programs across multiple divisions. You will drive inspection readiness, strategic quality guidance, and GCP compliance across trials. Remote in Massachusetts with ~30% travel, including international assignments. You will develop risk-based audit strategies, manage site and vendor audits, lead regulatory inspections, and investigate quality issues. #J-18808-Ljbffr Scorpion Therapeutics
- Life changing therapies. Global impact. Bridge to... ...Author and maintain global quality standards for aseptic processing... ...high-stakes regulatory inspections (FDA, EMA, MHRA),... ...to all PCI, cGMP, and GCP policies, procedures,... ...Philadelphia, PA, USA; Fully Remote, USAType: Full timeRemote workFull timeWeekend work
- ...Clinical Quality Manager - Fully Remote Direct Hire Help Shape the Future of Implantable... ...assurance activities supporting global clinical development... ...ensuring compliance with GCP, FDA, MDR, ISO requirements... ...agreements Regulatory inspection readiness ✅ Conduct audits...Remote workFull time
$163k - $191k
...Vaxcyte is a clinical-stage vaccine innovation... ..., Clinical Quality Assurance, to... ...: Lead global investigations... ...Issues, Audits, Inspections or during... ...CROs, and other GCP vendors. Support... ...Reports to: Senior Director, Clinical... ...Carlos, CA; Open to Remote Work...Remote work3 days per week- ...Job Description Clinical Quality Manager - Fully Remote Direct Hire \n \n Help Shape... ...assurance activities supporting global clinical development... ...ensuring compliance with GCP, FDA, MDR, ISO requirements... ...agreements \n Regulatory inspection readiness \n \n \n ✅...Remote work
$88.6k - $246.6k
...OverviewProvide strategic quality leadership and... ...with a strong focus on clinical research, clinical operations... ...operations, audit and inspection readiness programs, and... ...systems at a regional and/or global level. Partner with... ...Assurance (CQA), GCP, GxP, pharmaceutical, biotechnology...SuggestedFull timePart timeWork at officeImmediate startWorldwide$217.6k - $326.4k
...DescriptionGeneral Summary:The Sr. Director, GCP Operational Quality will advance and... ...and plans enabling clinical quality outcomes and real time inspection readiness. This... ...stakeholders across Global Clinical Operations,... ...as: 1. Hybrid: work remotely up to two days per week...Remote workFull timeWork experience placementSummer workFlexible hours2 days per week$137.8k - $206.8k
...Summary:The Senior Manager, Clinical Study Quality Lead provides study-level... ...Good Clinical Practice (GCP), applicable global regulations, study... ...compliance trend analysis, and inspection readiness. The role... ...not eligible for a fully remote work arrangement.Key Duties...Remote workFull timeSummer workFlexible hours2 days per week- AbbVie is seeking a Director of Clinical Quality Assurance to provide global quality oversight across therapeutic areas in clinical... ...embed quality early. You will drive inspection readiness, CAPA, and continuous improvement in GCP systems, partnering with clinical development...Worldwide
- Job DescriptionManager, Global Product QualityVictaulic World... ..., PA (Onsite Daily, No Remote Option)Full-Time | Global Quality Assurance -... ...for this roleReports to: Director, Global Quality Assurance... ...product evaluations.Coordinate inspection activities and partner with...Remote workPermanent employmentFull timeContract workTemporary workFor contractorsH1bWorldwideTrial period
$171k - $223k
...therapeutics to patients. This role delivers strategic GCP quality oversight across Denali's clinical trial portfolio, anchoring inspection readiness, risk-based quality decision-... ...aligned with ICH-GCP and applicable global regulations.Lead Sponsor inspection strategy...Remote jobLocal area- ...PharmaceuticalsSelling Points Drive clinical quality excellence in a hybrid... ...to Good Clinical Practices (GCP) and regulatory standards... ...investigator meetings and regulatory inspection preparedness.Maintain and... ...action plans.Supervise remote vendor audits, ensuring thorough...Remote work
$185k - $250k
...are advancing a clinical‐stage pipeline of... ...financed by top-tier global life sciences... ...Position Summary:The Director, Global GCP QA is responsible... ...Quality Oversight:Act as... ...operational efficiency.Inspection Readiness:Lead sponsor... ...location. Role can be REMOTE or ONSITE (if...Remote workContract work$227.9k - $308.3k
Overview:The Senior Director, Global Pharmacovigilance Quality Assurance Lead... ...performance monitoring, and inspection-readiness... ...work arrangement, or remotely within the United States... ..., Regulatory, Clinical, Commercial, and enterprise... ...knowledge of GCP interfaces is expected...Remote workFull timeTemporary workLocal areaFlexible hours$124.5k - $236.5k
...GCP Quality Assurance ManagerPrimarily responsible for... ...projects across one or more clinical programs to drive... ...procedures and applicable global regulations.As the... ...quality system and assure inspection readiness by designing... ...be performed remotely. Employees who are site...Remote workWork at officeLocal areaImmediate startMonday to Friday- ...Job Summary The Sr. Director & Deputy Chief Medical... ...personnel and operations, the clinic in Manila, and drives... ...facility operations, inspections, and internal audits,... ...operations in a global or distributed setting... ...stakeholders and manage global, remote teams Strategic...Remote workWorldwide
$118.6k - $158.6k
...partner is looking for a Global Clinical Study Manager based in... ...meet timelines, quality standards, and budget... ...study documentation, and inspection readiness. The role... ...SOPs, study plans, ICH/GCP requirements, and applicable... ...and programs. ~ Remote work opportunity...Remote jobWork at officeFlexible hours- The Emmes Group aims to hire a Sr. Director, Quality Assurance to lead global clinical QA strategy and a worldwide QA... ...Quality & Compliance and drives inspection readiness, metrics, CAPA management... ...communication skills. Position offers remote work flexibility for US-based...Remote jobWorldwide
- ...seeks a Senior Manager, Global Pharmacovigilance (PV) Quality Assurance to lead quality... ...from Cambridge, MA, with remote engagement across international... ....The role reports to the Director of Global PV Quality... ...compliance, audit programs, inspection readiness, and cross-...Remote job
- ...where it matters most. VIGILINT is seeking a Global Medical Logistics Manager to build and scale... ...property The Global Medical Logistics Manager will remotely manage distributed teams, conduct periodic site inspections, and ensure full compliance with U.S. Government...Remote workTemporary workFor contractorsLocal areaWorldwideFlexible hours
- Erasca, Inc., a clinical-stage precision oncology company, seeks a Senior or Executive Director of Quality Assurance GCP to lead GCP activities acrossPhases 1-3, regulatory submissions... ..., establish quality policies, manage inspections, and mentor QA staff while ensuring...Remote job
- Role: Senior Director of Quality Assurance overseeing clinical quality in biopharma, focusing on GCP and GPvP compliance across clinical development... ...risks lead regulatory inspections review clinical and... ...international travel Work Setup remote USA. #J-18808-Ljbffr Scorpion...Remote work
- ...GVP QA team providing Quality oversight of the global post-marketing... ...pharmacovigilance system, including clinical safety, full... ...as contributing to Inspection activities.This position reports to the Director, Global PV Quality... ..., conduct of audits remotely and in person,...Remote workWork experience placementWorldwide
$140k - $180k
Description The Senior Manager, Clinical Quality Assurance is responsible for... ...conducted to the highest GCP and quality standards and... ...and regulations. This is a remote-based position located in the... ...policies and standards Ensure inspection readiness of all regulated...Remote jobWork at office- ...at Intuitive. As a global leader in robotic-assisted... ...and execution of clinical studies. The... ...while ensuring high quality and compliancePerform on-site and remote site qualification... ...in internal audit/inspection and ensure sponsor... ...requirements (e.g., GCP and US and OUS guidelines...Remote workInterim roleLocal areaWorldwideFlexible hoursShift work
$185.6k - $232k
...Importance of the Role The Director, Corporate Quality, will provide... ...oversight across Sarepta’s Clinical Development and Real-... ...Clinical Practice (GCP) and Good Laboratory... ...issues, audits, and inspections.Review clinical trial... ...Extensive experience with Global Clinical trial...Full time$185k - $235k
...Therapeutics is seeking a Senior Director Quality GCP to provide strategic... ...activities supporting active pre-clinical and clinical programs... ...submissions. Lead and participate in inspection readiness activities for... ...GCP compliance with US and global regulations (FDA, EMA, ICH,...$115k
...solutions that advance global healthcare,... ...Supports internal clinical team members: protocol... ...(on-site or remote training, follow-up... ...issues in data entry (quality and completion),... ...to the protocol, GCP, SOP, and other applicable... ...authority inspections, sponsor/vendor audits...Remote workContract workLocal area- ...improve the world's health. From clinical trials to regulatory,... ...coordination with the Medical Monitor / Global Lead Physician, and according... ...and support any audits or inspections pertaining to assigned... ...knowledge in medical aspects of GCP, ICH, FDA, EMEA and other relevant...Remote workInternshipFlexible hoursNight shiftRotating shift
- ...Inc. is a publicly held clinical-stage biotechnology... ...Senior Manager, Clinical Quality serves as the study-level... ...studies; leading GCP quality risk management... ...and CAPAs; supporting inspection readiness; and maintaining... ...comply with applicable global regulations and guidelines...
$170.45k - $243.5k
...Astellas Astellas is a global life sciences... ...interventional drug programs, Clinical Pharmacology... ...timelines and quality standards,... ...Clinical Operations in inspection readiness activities... ...knowledge of ICH/ GCP guidelines and... ...in Northbrook, IL. Remote work from anywhere...Remote workWork at officeWork from homeWorldwide
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Remote Global Clinical Quality Director - GCP & Inspections. Be the first to apply!
- mental health clinical supervisor New York, NY
- clinical program director New York, NY
- hospital supervisor New York, NY
- medical project manager New York, NY
- medical assistant manager New York, NY
- medical case manager New York, NY
- regional director of clinical operations New York, NY
- remote medical billing manager New York, NY
- clinical data manager New York, NY
- medical marketing manager New York, NY







