Contract Clinical QA Director - ICH-GCP Leader
BioSpace
Alumis Inc. is seeking a Clinical Quality Assurance Director (CONTRACTOR) in South San Francisco, CA. The role partners with Quality leadership to provide ICH-GCP/GVP support across clinical studies, ensuring quality is embedded throughout development, with KPI development and risk mitigation. The incumbent will guide the quality organization strategy, support inspections readiness, and liaise with Health Authorities and CROs. Travel approx. 15% is expected. #J-18808-Ljbffr BioSpace
- Alumis Inc. is seeking a Clinical Quality Assurance Director (Contractor) to provide expert ICH-GCP/GVP QA leadership across ongoing clinical studies, reporting to the Exec. Director, GCPQA. You will embed quality across study lifecycles, establish metrics, and guide cross...SuggestedFor contractors
$90 - $98 per hour
...Description Job Description Job Title: Global Clinical Trial Leader Location: South San Francisco, CA Type: Contract Compensation: $90.00-$98.00/hour Work Model:... ...experience. ~ Working knowledge of GCP/ICH requirements, international regulatory guidelines...Contract workLocal areaFlexible hours- ...Therapeutics is seeking a Sr. Director, Head of Regulatory & Medical... ...You will guide internal and contract writers, ensure timely and high... ..., and collaborate with Clinical Science and Regulatory teams... ...MAA), a deep understanding of GCP/ICH and FDA #J-18808-Ljbffr BioSpaceContract work
$85 - $96 per hour
...****@*****.*** are seeking a Contract Senior Manager, Clinical Site Budgets and Outsourcing to... ...and applicable regulations (e.g., GCP). The position is responsible for ensuring... ...Practice (GCP), FDA regulations, and ICH guidelines as they relate to sponsor...Contract work$186k - $220k
...drugs. We are advancing a clinical‐stage pipeline of... ...Summary:The Associate Director of Clinical Operations... ...with study protocols, GCP, and regulatory requirements... ...activities.Strong knowledge of ICH-GCP guidelines, FDA,... ...an actual or implied contract between Structure...Contract workRemote work$235.5k - $329.5k
Senior Director, Clinical Research-Medical Director (Oncology) Vir Biotechnology... ...role requires a physician leader with a strong track record... ...clinical trial design, GCP/ICH guidelines, regulatory requirements... ...Labor’s Office of Federal Contract Compliance Programs (OFCCP)...Contract workFull timeFor contractorsFor subcontractorWork at officeWork visa3 days per week- ...Description Greetings from IT Engagements Role : Global Clinical Trial Leader (Contract Role) Location : South San Francisco, CA (three days... ...desired. · Knowledge: Working knowledge of GCP/ICH requirements, international regulatory guidelines, and...Contract workLocal areaRemote workFlexible hours
$199.2k - $246.1k
Associate Director Clinical Quality Assurance and GxP Compliance... ...governance for the GCP Audit Program,... ...U.S. FDA, EMA, and ICH-GCP regulations, providing... ...functional leaders. Direct the evaluation... ...strategic direction to QA personnel, SMEs, and contract service providers in...Contract workFull timeWork at officeLocal areaFlexible hoursShift work2 days per week3 days per week$232k - $283k
...diseases. As an Oversight Director, Clinical Operations supporting an asset... ...compliance with SOPs, ICH-GCP, applicable regulatory requirements... ..., we also expect our leaders to demonstrate the following... ...governance, performance management, contract negotiations, and budget...Contract workInterim role$93.1k - $232.8k
...treatments to patients faster.Drive global clinical trials from first site activation to... ...functional teams, and ensure compliance with ICH-GCP, regulatory requirements, and study... ...protocols, and regulatory standardsFinancial & Contract ManagementManage study financials,...Contract workFull timePart timeWork at officeImmediate startWorldwide$96 per hour
...Description Job Description Job Title: Clinical Contracts Manager Job Description We... ...of Good Clinical Practice (GCP), FDA regulations, and ICH guidelines. Working knowledge of... ...About Actalent Actalent is a global leader in engineering and sciences...Contract workTemporary work$102.5k - $285.5k
QVIA Biotech is seeking an Associate Clinical Project Management, Director: IQVIA Biotech is a full-service... ...clinical studies in line with agreed upon contracts while optimizing speed, quality and... ...regulatory requirements i.e. ICH GCP and relevant local laws,...Contract workFull timePart timeLocal areaImmediate startWorldwide- insitro is seeking a Senior Director of Quality Assurance to build a pragmatic, inspection-ready quality function for clinical-stage operations, owning GMP and GCP quality, data integrity, and vendor oversight. Based in South San Francisco with a hybrid schedule, you will...
- ...employee deserves a great leader. People Leaders are the... ....Job DescriptionThe Clinical Program Manager is responsible... ...and oversight of contract research organizations (... ...Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct...Contract workFull timeFor contractorsLocal areaWorldwide
- Merck in South San Francisco, CA, seeks a Senior Director, Clinical Science - Hematology to lead strategic Clinical Science across the hematology portfolio, guiding study design, data interpretation, and cross-functional collaboration within a matrix organization. You...
$275k - $360k
...drugs. We are advancing a clinical‐stage pipeline of... ...collaborators, board of directors, investors, key opinion leaders and vendors, as appropriate... ...including FDA, EMA, and ICH guidelines. Ability to interpret... ...constitute an actual or implied contract between Structure...Contract work$166k - $209k
...peptide drugs. We are advancing a clinical‐stage pipeline of... .... Reporting to the Associate Director, GxP Operations, this role is... ...Part 11, EU Annex 11, GAMP 5, ICH guidelines, data integrity (ALCOA+... ...constitute an actual or implied contract between Structure...Contract workWork at officeRemote work$250k - $290k
...Description Erasca is a clinical-stage precision... ...: it is a contraction of our audacious... ...or Executive Director Quality Assurance GCP will lead GCP activities... ...of QA GCP operations in... ...Extensive knowledge of ICH GCP (E6) and... ...functional groups and leaders ~ Demonstrated...Temporary workCasual workLocal areaWorldwideFlexible hours$200k - $230k
...Allogene is seeking a Product Quality Leader (PQL) to oversee Allogene’s CAR T... ...manufacturing internally or at contract manufacturing organizations (CMO) for clinical and future commercial use, including... ....Escalates, as needed, to QC and QA heads in event of unexpected and...Contract workFull timeWork experience placementWork at officeLocal area- We're seeking a Director of Clinical Affairs to own end-to-end execution of regulatory... ...11, 50, 56, 812, 820), ICH‑GCP, ISO 14155, and SaMD... ...vendor relationships, including contract negotiation and performance... ...and legal teams Support RA/QA peers on FDA interactions, pre...Contract work
- ...Description Our client, a world leader in biotechnology and life... ...sciences, is looking for a "Global Clinical Trial Leader" based out of... ...). Job Duration: Long Term Contract (Possibility Of Extension)... ...excellence, and compliance with GCP/ICH and regulatory requirements....Long term contract
$200k - $250k
...The Role We're looking for a Director of Clinical Affairs who will own the end... ...11, 50, 56, 812, 820), ICH-GCP, ISO 14155, and applicable SaMD... ...clinical vendors , including contract negotiation, performance oversight... ...by supporting your RA/QA peers in the creation of pre...Contract workFull timeImmediate startWorldwideNight shift- Scorpion Therapeutics seeks a senior Clinical Science leader to guide hematology drug development and strategy across multiple studies. You will... ...leadership, regulatory compliance, and mentoring Directors and Scientists within a matrix organization at South San Francisco...
$80 - $100 per hour
...Early Development (R&D) The R&D Global Clinical Trial Leader (CTL) is accountable for the execution... ...and vendors deliver strictly against contracted scopes of work. * Financial Input: Provide... .... * Knowledge: Working knowledge of GCP/ICH requirements, international regulatory...Local areaFlexible hours- ...Director Of Quality AssuranceAt Medicines360, we are more than... ...Quality Management System, QA personnel, and Quality initiatives... ...areas, external partners, contract facilities, and suppliers... ...Quality guidance for clinical studies to ensure GCP compliance, qualification of...Contract workFull timeWork at officeLocal areaWorldwide
$268k - $331k
...employees, managers, and leaders to submit unsolicited... ...recruiters with or without a contract in place with IDEAYA... ...disease and improving clinical outcomes for patients... ...an experienced Medical Director of Patient Safety and Pharmacovigilance... ...regulations (FDA, EMA, ICH) Strong medical...Contract workWork at officeLocal areaWork from home$164k - $205k
...Medicines is a late-stage clinical oncology company developing... ...), Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines. Be a team leader, providing guidance and oversight... ...and management of contract research organizations (CROs...Contract workFull timeTemporary workWork at officeLocal area- ...finance team, drive continuous improvements, manage NetSuite and related systems, and collaborate with Revenue Operations and Legal on contract terms and revenue conversion. This is a high‑impact role with competitive compensation and stock options. #J-18808-Ljbffr...Contract work
- .... You will lead continuous process improvements, drive scalable controls, and partner with Revenue Operations and Legal to ensure contract terms convert to revenue. Requirements include a Bachelor's in Accounting/Finance, CPA preferred, and deep knowledge of ASC 606/IFRS...Contract work
$240k - $275k
Nektar has an exciting opportunity for a Director, Clinical Data Management on the Clinical Data... ..., and database release. Manages Contract Research Organizations (CROs) and service... ...required. Experience and understanding of ICH and GCP is required. Demonstrates initiative...Contract workLocal area
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