Director, GCP Inspection Readiness & Audit Strategy
Doist
Kardigan is seeking a Director, GCP Inspection Readiness and Audits Strategy to lead Kardigan’s approach to regulatory inspections in the US and globally. Based in Princeton, NJ, on-site four days a week, you will partner with Clinical Quality Assurance and leads to design and execute an annual risk-based audit plan. You will drive inspection readiness, manage cross-functional teams, and oversee external auditors to ensure compliance with GCP and FDA BIMO standards. #J-18808-Ljbffr Doist
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Director, GCP Inspection Readiness & Audit Strategy in South San Francisco, CA vacancy
$194k - $250k
...values are the foundation of our work, empowering us to make a real difference, every day. Position Title: Director, GCP Inspection Readiness and Audits Strategy Department: Quality Reports To: Vice President, CMC Quality Location: Princeton, NJ (...SuggestedFull timeKardigan
South San Francisco, CA3 days ago$190k - $205k
...fun, seriously.POSITION SUMMARYThe Associate Director of GCP/GVP/GLP-QA is responsible for supporting Mirum... ...Clinical Study Management Teams.Manage/Support BIMO inspection readiness activitiesSupport GCP/GCLP/GVP internal audits.Provide quality oversite for the GCP/GVP/GLP...SuggestedContract workLocal area$159k - $221k
...into commercial operations. The process and strategy team within fleet operations is... ...improvement initiatives for the Mission Readiness program. The Mission Readiness team is responsible for charging, cleaning, inspecting, and performing other similar tasks where...SuggestedFull timeTemporary workRelocation package- Introduction to roleAre you ready to lead the charge in... ...? As a Global Study Director (GSD), you will play a... ...requirements, and ICH/GCP guidelines. Your... ...Collaborate to establish strategies for increasing efficiency... ....- Ensure studies are inspection-ready at all times.-...SuggestedFull time
$155k - $410k
...value in their business deals.Those in deal strategy at PwC will focus on providing strategic... ...(e.g. refer to specific PwC tax and audit guidance) the Firm's code of conduct, and... ...businesses, unlocking growth opportunities. As a Director, you set the strategic direction, lead...SuggestedFull timeTemporary workH1b$163k - $200k
...Summary The Associate Director, Trial Master File at... ...and controls support inspection readiness, regulatory compliance... ...provides leadership over TMF strategy, vendor oversight,... ...matter expert for audits, health authority inspections... ...accordance with ICH GCP and regulatory...For contractors- ...into commercial operations. The process and strategy team within fleet operations is... ...improvement initiatives for the Mission Readiness program. The Mission Readiness team is responsible for charging, cleaning, inspecting, and performing other similar tasks where...Temporary workRelocation package
Zoox
Foster, CA29 days ago $199.2k - $246.1k
...Summary The CQA Associate Director provides strategic leadership... ...of quality assurance strategies, policies, programs, and initiatives... ...systems, strengthen inspection readiness, and drive enterprise‑wide... ...guidance, and governance for the GCP Audit Program, ensuring effective...Full timeContract workWork at officeLocal areaFlexible hoursShift work2 days per week3 days per week$232.6k - $287.4k
...yield rare possibilities The Director, CMC Quality Control - Small... ..., phase‑appropriate, and inspection‑ready execution. QC testing experience... ...phase‑appropriate QC strategies and data integrity. Lead the... ...submissions, inspections, and audits, including authoring and defending...Ongoing contractFull timeContract workWork at officeLocal areaFlexible hours2 days per week3 days per week$243.1k - $314.6k
...for the next wave of passionate and ambitious people ready to make a direct impact.We believe every employee deserves... ...lives of patients for generations to come. As the Director, US Medical Affairs, Liver Strategy, at Gilead you are a critical strategic and operational...Full timeFor contractorsLocal area$191.1k - $320.6k
...Salesforce's core values at the heart of it all.Ready to level-up your career at the company... ...for a strategic, results-driven Senior Director of Global Readiness to lead the product feedback loop and field enablement strategy across our Agentforce and Data 360 portfolios...Full time$164k - $304.7k
...Salesforce's core values at the heart of it all.Ready to level-up your career at the company... ...is building the future of revenue strategy, and this role is at the center of it.The... ...a sales/commercial practice at scale for Director level; 13+ years proven experience in GTM...Full timeWork at officeImmediate startShift work3 days per week$169.6k - $315k
...PositionGenentech is seeking a transformational Director, Occupational Hygiene to drive... ...team to develop and implement multi-year strategies to proactively protect people, identify... ...serve as the key lead for regulatory inspections.Architect and implement comprehensive long...Full timeWork experience placementLocal area$160k - $180k
The Associate Director, IT Compliance is responsible for organising... ..., compliance assurance, audit readiness, vendor and sponsor audit responses... ...and control evidence remain inspection-ready and aligned with... ..., as well as participate in strategy discussions related to AI ISMS...Contract workWorldwideFlexible hours- ...Associate Director, Regulatory Affairs The Associate Director, Regulatory Affairs... ...and execution of clinical regulatory strategies and regulatory development activities... ...policies and procedures, maintaining inspection-ready documentation and practices. Risk Identification...Work at office
Zai Lab (US) LLC
South San Francisco, CA3 days ago - ...Pharmaceutical is seeking an Associate Director of Quality Assurance who... ...and evolution of QA strategies, aligning with global... ...senior leadership to strengthen inspection readiness and drive enterprise... ...requires proven experience in audits, regulatory inspections, and...
$226.19k - $292.71k
...Director, Real-World Evidence Inflammation At Gilead, we're creating... ...and ambitious people ready to make a direct impact.... ...development and execution of the RWE strategy in support of an... ...development, disclosure, and inspection/audit readiness. Communicate effectively...WorldwideGILEAD
San Mateo, CA8 hours ago- ...Description Job: Associate Director, Clinical Operations (Late-Phase... ...implement the operational strategy for assigned trials, and... ...in compliance with SOPs, ICH/GCP guidelines, and FDA regulations... ...trial execution and GCP inspection readiness. May manage direct reports...Full timeFor contractorsLocal area
Latigo Bio
San Francisco, CA13 days ago $140k - $180k
...Technical Program Manager for Manufacturing Strategy & Operations, you will serve as a strategic partner to the Director and leadership team. You will translate manufacturing... ..., equipment constraints, and production readiness.Experience leading complex cross-functional...Local areaShift work$210.38k - $272.25k
...for the next wave of passionate and ambitious people ready to make a direct impact. We believe every... ...lives of patients for generations to come. As aThe Director, Corporate Storytelling & Editorial Strategy at Gilead, you will shape Gilead’s editorial strategy...Full timeFor contractorsFreelanceLocal areaShift workGilead Sciences
Foster, CAa month ago$155k - $185k
...Associate Director, EH&S and Facilities Sutro is seeking an Associate... ...hazard assessments, periodic inspections, policy and SOP development,... ...to resolution. Review and audit waste handling procedures and... ...and equipment setup, service readiness, vendor scheduling and escorting...Local areaSutro Biopharma
South San Francisco, CA5 days ago$155k - $190k
...Job Title: Associate Director, Clinical Data Systems and Informatics Location: San Mateo... ...study requirements and ICH E6 (R2) GCP standards Oversee the design, build, and... ...documentation in accordance with regulatory inspection readiness standards Coordinate with clinical...Clearnotehealth
San Mateo, CA8 hours ago- ...Therapeutics Inc. is seeking an Associate Director of Biosample Operations in South... ...oversight, guide biosample strategy, and partner with QA/Regulatory to ensure GCLP and GCP compliance across clinical programs. You will manage lab audits, CAPA resolution, and cross-...
- ...thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Director - PKDM - Small Molecule Portfolio Strategy & Leadership What You Will Do In this vital role you will serve as a strategic PKDM‑BA leader on cross‑...Flexible hours
$218.26k - $305.57k
...critical operations worldwide. Director Role We are seeking a... ...validation, and production readiness. Responsibilities Lead hardware... ..., debugging, and validation strategy for hardware and firmware.... ...(CDL drivers only), vehicle inspection requirements, CDL requirements...Permanent employmentContract workTemporary workLocal areaWorldwide$245k - $302k
...organized, and skilled Senior Director, Medical Writing to provide strategic... ...development and registration strategies. You will partner closely... ..., compliant, submission‑ready documentation. Plan and manage... ...regulatory requirements (ICH, GCP, CTD/eCTD). Proven ability to...Temporary workFor contractorsWork at office- Ultragenyx Pharmaceutical Inc. is seeking a Director, CMC Quality Control - Small Molecules. This role provides technical and strategic... ...QC governance with CMOs/CLs, ensuring phase‑appropriate and inspection‑ready execution, including oversight of analytical testing, method...
- Databricks is seeking a senior leader to head Global GCP Go-To-Market Strategy & Business Development in San Francisco. The role reports to the Global VP, Databricks on GCP and leads a team focused on accelerating customer outcomes with Databricks on GCP. You will design...
- ...organized, and skilled Senior Director, Medical Writing to provide strategic... ...What You’ll Do Lead authoring strategy and oversee the successful... ..., compliant, submission‑ready documentation. Plan and manage... ...regulatory requirements (ICH, GCP, CTD/eCTD). Proven ability to...Temporary workFor contractorsLocal area
$190k - $205k
...Management System (QMS), driving consistency, inspection readiness, and continuous improvement... ...timelines, resource planning, risk mitigation strategies, and communication plans.Author and/or... ....Support internal and external audits and health authority inspections by providing...Local area
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Director, GCP Inspection Readiness & Audit Strategy. Be the first to apply!
Related searches
- inspection supervisor South San Francisco, CA
- electrical inspection South San Francisco, CA
- inspection operator South San Francisco, CA
- building inspection South San Francisco, CA
- construction inspection South San Francisco, CA
- inspection coordinator South San Francisco, CA
- final inspection South San Francisco, CA
- inspection South San Francisco, CA
- health inspection South San Francisco, CA
- inspection manager South San Francisco, CA