Senior Clinical Quality Leader - GCP & Inspections
Braveheart Bio
Braveheart Bio, a clinical-stage biopharmaceutical company focused on hypertrophic cardiomyopathy, seeks an Associate Director, Quality to own quality oversight for assigned studies and vendors. You will serve as a senior quality advisor across clinical programs and lead quality decisions within scope, reporting to the Director, Quality.
You will develop quality strategies, ensure GCP compliance, manage audits and CAPA, and guide inspections and TMF quality.
#J-18808-Ljbffr$141.1k - $262.1k
...transforming society.The OpportunityAs a Quality Partner within Early Clinical Development (ECD) Quality, you will... ...the primary Good Clinical Practice (GCP) quality advisor and strategic... ...on experience with Health Authority inspection preparedness, sponsor/site inspection...QualitySeniorLocal areaRelocation package3 days per week- ...AbbVie is seeking an experienced leader to oversee direction, planning and interpretation of clinical trials within one or more... ...functional teams to generate high-quality data that informs product strategy... ...of regulatory requirements and GCP standards. Excellent...QualitySenior
- ...Genentech, part of the Roche group, seeks a Principal Clinical Quality Compliance and Policy Lead to champion a proactive quality culture... ...cross-functional alignment, oversees QMS activities, and leads inspection readiness initiatives, with a strong emphasis on governance,...QualitySenior
- ...Nurix Therapeutics is seeking an experienced Clinical Operations professional to own assigned... ...biological sciences, 25% travel, and strong knowledge of FDA, EMA, ICH and GCP guidelines. You’ll advance trial quality and prepare for regulatory inspections. #J-18808-LjbffrQualitySenior
- ...A clinical quality assurance organization is seeking a Senior Manager, Clinical Quality Assurance in South San Francisco. In this critical role, you will drive quality... ...studies, ensuring compliance with essential GCP standards. You will lead audits, provide mentorship...QualitySenior
- ...supporting an international clinical research organisation... ...with an experienced Senior Clinical Research Associate... ...teams. Monitor site quality, protocol compliance,... ...complete, accurate and inspection-ready. Oversee investigational... ...knowledge of ICH-GCP and clinical research quality...QualitySeniorPermanent employmentImmediate startRemote work
- ...San Francisco seeks a physician leader to oversee direction, planning... ..., and interpretation of clinical development programs. You will... ...functional teams to deliver high-quality clinical data aligning with product... ...communication. Emphasis on GCP adherence and collaboration...QualitySenior
- ...Team Lead) | Early Phase Clinical ResearchLocation:... ...seeking an experienced Senior Medical Officer to provide... ...investigator meetings.Support quality management activities,... ...audits, and regulatory inspections.Drive continuous... ...Strong understanding of GCP, participant safety, and...QualitySenior
$141k - $261.8k
...In Pharma Development Quality (PDQ), we strive for confidence... ...across Molecules (GCP), Products (Drug and/or... ..., encompassing Good Clinical Practice (GCP), Good Pharmacovigilance... ...seeking an experienced Senior Quality Lead to join... ...and leading/supporting inspections of key molecules. CSV...QualitySeniorLocal areaRemote workRelocation package- ...Unlearn is seeking a Senior Clinical Data Scientist to transform clinical data into high-quality datasets for modeling and analysis. You will collaborate with machine learning scientists, engineers, and clinicians to build robust data products across multiple disease areas...QualitySenior
$240k - $290k
...them for success in the clinic. The successful candidate... ...Role THE ROLE The Director/Senior Director, Clinical... ...compliance with regulatory and quality standards. This is an exciting... ...efficiency. Ensure inspection readiness and adherence to ICH-GCP, SOPs and global regulatory...QualitySeniorFull timeContract work- Genentech is seeking a Quality Partner within Early Clinical Development (ECD) Quality to champion a proactive, risk-based quality culture and ensure safe... ...progression to patients. You will act as the primary GCP quality advisor to study teams and external partners, embedding...QualitySenior
- ...Senior Director, Clinical Operations Lead the execution of groundbreaking... ..., ensuring high-quality study delivery while... ...clinical operations leader who thrives in a fast... ...compliance with ICH‑GCP and applicable global... ...requirements. Maintain inspection readiness and support...QualitySenior
- ...Vir Biotechnology seeks a Senior Director of Clinical Operations to lead portfolio-level strategy and... ...trials against timelines, budgets, and quality standards Provide strategic... ...models Understanding of regulatory requirements and inspection-readiness standards...QualitySenior
- ...Staffing in California is seeking an Associate Director, Medical Writing to lead and oversee the creation and review of high-quality clinical and regulatory documents in compliance with ICH and global guidelines. The role emphasizes project leadership, cross-functional...QualitySenior
- ...Alameda Health System in Oakland, California is seeking a Clinical Nurse V to manage nursing services in assigned patient care areas,... ...management, coordinates with physicians and other departments, drives quality improvement, oversees staff development, and ensures compliance...QualitySenior
- ...Senior Clinical Trial Manager, Clinical Operations (Site/Study... ...deliver within agreed quality and performance... ...operational excellence and inspection readiness in all aspects... ...compliance with ICH/GCP, global regulations, and... ...audience (eg peers vs leaders; education vs driving...QualitySeniorContract workWork at office
- ...research through late-stage clinical development and commercialization... ...accurate, and compliant with GCP requirements. Lead internal... ...with Regulatory Affairs, Quality, and Pharmacovigilance on regulatory... ...reporting, audits, and inspections. Partner with Clinical Development...QualitySeniorFull timeContract workLocal areaRemote workFlexible hours
$250k - $311k
...Executive Director, Clinical OperationsXaira... ...strategy, delivery, quality, and cost of Xaira... ..., and requires a leader who is comfortable... ...organization, and senior leadership. The Executive... ..., and regulatory inspections.Define and execute... ...with ICH GCP, applicable global...QualitySeniorFlexible hours$174.7k - $324.5k
...Opportunity As the Principal Clinical Quality Compliance and Policy Lead,... ..., Good Clinical Practice (GCP) compliance expertise, and... ...Direct Health Authority inspection readiness initiatives , Standard... ...Problem Solver & Matrix Leader: You have a proven track record...QualityLocal areaRelocation package3 days per week$180k - $220k
...Senior Clinical Trial ManagerSouth San FranciscoMarea Therapeutics... ...interns to senior leaders. Our environment is... ...and in compliance with GCP and regulatory requirements... ...to ensure high-quality delivery of clinical trial... ...improvements.Inspection Readiness, Quality, and...QualitySeniorFull timeLocal area3 days per week- ...member of the Roche group, is seeking a Senior Quality Lead in Pharma Development Quality (PDQ... ...options. The role requires strong GCP knowledge, device/CSV experience preferred... ...influence stakeholders and manage regulatory inspections across global teams. #J-18808-Ljbffr F...QualitySeniorRemote work
$125.1k - $232.3k
...Opportunity As a Global Clinical Trial Leader (CTL) within Genentech Research... ...under the leadership of the Senior CTL. In this role, you will... ..., Trial Master File (TMF) quality, and Clinical Trial Management... ...working knowledge of ICH/GCP guidelines, international regulatory...QualityLocal areaRelocation packageFlexible hours3 days per week$252.64k - $306.14k
...seeking a strategic, scientifically grounded leader to serve as the Senior Director for Clinical Pharmacology & Pharmacometrics. This... ...decisions Improve the speed, quality, reproducibility, traceability, and inspection-readiness of pharmacometrics and clinical...QualitySeniorHourly payFull timeTemporary workFlexible hours- Genentech is seeking an experienced Senior Quality Lead in South San Francisco, CA. You will shape QA strategies, lead audits, and manage regulatory inspections for post-approval products, leveraging GCP, GVP, and device/C SV knowledge. Responsibilities include designing...QualitySeniorRemote job
- ...Description Job Description Clinical Laboratory Scientist (CLS) – Senior Andrologist RMA... ...testing, and laboratory quality management while... ...their career with a global leader in reproductive medicine... ...documentation for regulatory inspections. Sperm Banking &...QualitySeniorFull timeWork at officeFlexible hoursWeekend workEarly shift
- ...certification in the relevant specialty, with residency completion as applicable. Positions include responsibilities across hospitals, clinics, and public health programs within the SF Health Network, with emphasis on equity and high-quality patient care. #J-18808-LjbffrQualitySenior
- ...transforming society.The OpportunityAs a Senior Pharmacovigilance (PV) Clinical Scientist in our US Patient Safety... ...teams, and oversee external vendor quality. In this role, you will champion... ...global Health Authority regulatory inspections.Who You AreAdvanced Healthcare...QualitySeniorFull timeLocal area
- ...Home Health & Hospice, based in San Francisco, seeks a DPCS to own clinical performance across Bay Area branches. You will set agency-wide standards, supervise branch Clinical Managers, and drive quality, compliance, and patient outcomes in line with participation in...QualitySeniorFull timeWork from home
$90.2k - $175.1k
IQVIA is now hiring for a Senior Clinical Research Associate located on the West Coast, US to join... ...contribute to the integrity and quality of clinical research data.Key ResponsibilitiesConduct... ...scope of work, Good Clinical Practice (GCP), and ICH guidelines.Collaborate with...QualitySeniorFull timePart timeImmediate startWorldwide
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