Senior Director, Inspection Readiness
Absci
Absci seeks a Senior Director of Inspection Readiness to lead clinical operations compliance and inspection preparedness across its development portfolio. This role provides sponsor-level oversight of GCP compliance, operational processes, and regulatory adherence, reporting to the SVP of Global Clinical Operations.
Responsibilities
- Provide sponsor-level leadership for inspection readiness and GCP compliance across clinical studies and programs
- Develop and maintain risk-based inspection readiness framework supporting the clinical portfolio
- Assess clinical studies for readiness gaps in documentation, oversight, data integrity, and regulatory adherence
- Coordinate cross-functional remediation efforts with Clinical Operations, Quality, Regulatory, and Development functions
- Establish and oversee clinical trial registration, results-reporting, and training compliance processes
Requirements
- Senior-level clinical operations experience with inspection readiness and GCP compliance expertise
- Demonstrated experience leading cross-functional teams in regulated clinical development environments
- Knowledge of clinical trial documentation, data integrity, and regulatory inspection standards
- Experience developing risk-based compliance frameworks and remediation processes
- Familiarity with clinical trial registration and results-reporting requirements (ClinicalTrials.gov)
- Strong project management and issue tracking capabilities in clinical development
Vacancy posted 5 days ago
Similar jobs that could be interesting for youBased on the Senior Director, Inspection Readiness in Remote vacancy
- ...transform complex workflows into intelligent, scalable, and future-ready systems. About the Role This role connects real... ...requirements, with direct exposure to regulatory interaction or inspection (FDA, NMPA/CDE or equivalent). Practical understanding of how...SeniorPermanent employmentFull timeRemote workWorldwide
Galatek Life Sciences
United States18 hours ago $142.5k - $256.5k
The Role:The Associate Director of Investigations & Operational Performance is responsible for strengthening Norwood's investigation excellence, operational performance, and state of inspection readiness. This leader drives rigorous investigation and systemic problem solving...SuggestedPermanent employmentFull timeWork from homeModerna Therapeutics
Norwood, MA4 days ago$190k - $210k
...geographies. You will shape priorities with senior GTM leaders, make clear investment and... ...-Obsessed about building organizational readiness that helps Huntress execute its growth... ...managers play in coaching, reinforcement, inspection, and accountability. You can lead a...SuggestedFull timeRemote workWorldwideHome officeForgepoint Capital
United States11 days ago$155.2k - $232.8k
...micron-level die-interconnects; macro defect inspection of wafers and packages; metal... ...efficient.Job Summary & ResponsibilitiesThe Senior Manager, Technical Product Support is a... ...Service NPI focused on global technical readiness for FOAK (First of A Kind) and beta customer...SeniorPermanent employmentFull timeRemote workOnto Innovation
Wilmington, MA3 days ago- ...transportation and their terminals and serves as a senior technical leader and trusted advisor to... ...address risk, innovation, and future-ready opportunities. Provides leadership with... .../comprehensive investigations and inspections of proposed and existing site conditions...SeniorContract workFor subcontractorWork at officeLocal areaRemote workFlexible hours
WSP Group
Trenton, NJ4 days ago - ...brighter way forward. The Opportunity - We are currently seeking a Senior Director to join our Institutional Valuation Practice.The... ...select work, partnering with leadership to identify targets Only inspect properties for tier 1 clients, where client interaction can be...SeniorFull timeTemporary workLocal area
Jones Lang LaSalle
Orlando, FL3 days ago - ...Role: Associate Director, Inspection Readiness, supporting clinical trial operations by ensuring compliance and inspection preparedness across trials and service providers. Responsibilities establish and maintain inspection frameworks optimize digital tools...Remote work
$212k - $333.19k
...that will inspire you and empower you to shine? Join us as a Senior Director, Pharmacovigilance Process Lead in our Cambridge, MA office... ...enabled capabilities to enable streamlined, compliant, and inspection ready E2E processes with clear roles and responsibilities. By...SeniorMinimum wageFull timeTemporary workWork at officeLocal areaRemote work$147.5k - $221.3k
Job DescriptionGeneral Summary:The Associate Director, CMC Quality Compliance and Inspection Readiness, is responsible for inspection readiness and compliance of external sites including evaluating, improving, and monitoring commercial level quality compliance and quality...Full timeSummer workRemote workFlexible hours2 days per weekVertex Pharmaceuticals
Boston, MA18 hours ago$258.33k - $280k
...bonus Position Summary This role is a highly visible, senior quality systems professional who thrives in fast‑paced, resourceful... ..., reports, periodic reviews, and revalidations. Maintain inspection‑readiness at all times. Cross‑functional Enablement: Support...SeniorRemote work3 days per weekCandel Therapeutics, Inc.
Needham Heights, MA3 days ago$215k - $240k
...and contract testing laboratories. Author, review, and approve analytical content for global regulatory submissions and support inspections. Ensure external partners operate in accordance with cGMP requirements and quality agreements. Qualifications: Ph.D in Analytical...SeniorRemote jobContract work- ...for an accommodation or an alternative application process. Senior Director, Preclinical Ophthalmology Full Time Direct King of Prussia,... ...as the subject matter expert (SME) for all onsite audits and inspections, and the responsible party for addressing requests and...SeniorFull timeContract workTemporary workRemote workFlexible hoursNight shiftWeekend workAfternoon shift
- ...partners to ensure clinical data, regulatory documentation, and monitoring activities are complete, accurate, and inspection-ready. The selected Senior CRA will join an established study team during an important period leading into database lock and provide immediate...SeniorFull timeTemporary workInterim roleImmediate startRemote work
Axiom Path
San Diego, CA16 days ago - ...seeking qualified applicants for the position:Senior Manager, Material Preservation and... ...maintenance inventory while ensuring operational readiness, maximizing equipment reliability,... ...preservation standards, procedures, inspection requirements, storage criteria, OEM requirements...SeniorFull timeFor contractorsWork at officeRemote workMonday to FridayWeekend work
Venture Global LNG
Houston, TX2 days ago $169.35k - $237.09k
...enterprise-grade broadband to the most demanding customers on Earth. As Senior Product Manager for User Terminals, you will own Terawave's... ...Road Test, Hours of Service, Drug and Alcohol Testing, vehicle inspection requirements, CDL requirements (if applicable) and hazardous...SeniorPermanent employmentContract workTemporary workLocal areaRemote workWorldwide$145k - $165k
Major League Baseball is looking for a Senior Director, Consumer Experience to lead the Consumer Experience (CX) team and oversee all aspects... ...provide solutions, and always put the Team first. For those ready to step up to the plate and join the major leagues, MLB takes...SeniorTemporary workWork experience placementTickets.com
New York, NY1 day ago$110k - $240k
...conditions. Ankura advisors partner with senior management to assess the situation and quickly... ..., including lenders, boards of directors, employees, investors, and creditor constituenciesCustomer... ...self-directed with preparation of client ready document and presentation...SeniorFull timeFlexible hoursWeekend workAnkura Consulting Group
Dallas, TX3 days ago- ...leadership journey. Reporting to the Chief People Officer, the Senior Director, Talent Management will lead the enterprise talent management... ..., leadership capability, employee development, workforce readiness, and organizational growth across the company.This leader owns...SeniorFull timeRemote workFlexible hoursShift work
Manhattan Associates
Atlanta, GA18 hours ago - Role SummaryAnthropologie is looking for a Sr. Director of Sourcing for Furniture. Reporting to the Executive Director of URBN Sourcing... ...Internal Responsibilities: Cultivate a high-performing, future-ready team and establish operational structures that ensure both day-...SeniorSeasonal workWork at officeRemote workOverseas
Urban Outfitters
Philadelphia, PA4 days ago $145k - $160k
...experience the greatness of the human spirit at its best. Are you ready to be part of the world's largest humanitarian network?... ...at work. The American Red Cross is currently seeking a Senior Philanthropy Director to support the Transformational Giving team. An ideal...SeniorFull timeTemporary workLocal areaWork from homeRelocationFlexible hoursThe American National Red Cross
Houston, TX18 hours ago- ...President for Critical Event Preparedness and Response (CEPAR), the Senior Director for CEPAR serves as the AVP's deputy and provides strategic... ...during emergencies. Leads preparedness training, exercises, readiness assessments, after-action reviews, and corrective action...SeniorWork at officeLocal areaRemote workWork from home
Emory University
Atlanta, GA1 day ago $252k - $378k
Job DescriptionGeneral Summary:The Senior Director (non-MD) serves as a US Medical Affairs asset lead responsible for the strategic planning... ..., and Corporate Communications to ensure aligned launch readiness and integrated execution in a matrix environment.Drive the design...SeniorFull timeSummer workRemote workFlexible hoursShift work2 days per weekVertex Pharmaceuticals
Boston, MA3 days ago$210.9k - $379.2k
...relationships across functions and to communicate effectively with senior business leaders, as well as other professionals and colleagues... ...complex issues in a simple way and provide executive-ready IP litigation insights concerning litigation events, risks and threats...SeniorPermanent employmentFull timeWork at officeWork from homeModerna Therapeutics
Somerville, MA3 days ago$250k - $300k
...love to hear from you.POSITION TITLESenior Director, Identity and Access ManagementPOSITION... ...travel, approximately 25%.YOUR ROLEAs Senior Director, Identity and Access Management... ...least-privilege enforcement, and audit readiness across all business applications and platforms...SeniorFull timeWork at officeRemote workGenworth Financial
Richmond, VA2 days ago$137.6k - $383.3k
Job OverviewThe Senior Director, Pharmacokinetics provides strategic, scientific, and operational leadership across Clinical Pharmacology... ...Oversee the quality, consistency, timeliness, and regulatory readiness of statistical, programming, and PK/PD deliverables, including...SeniorFull timePart timeWork at officeImmediate startRemote workWork from homeWorldwideIQVIA
Durham, NC3 days ago- ...organization, apply now.We are currently seeking a Alliance Mangement Senior Director to join our team in Plano, Texas (US-TX), United States (US).... ...-specific use cases, messaging/value propositions, and seller-ready collateral in alignment with Global Practices, Specialty...SeniorWork at officeRemote workFlexible hours
NTT DATA
Plano, TX1 day ago $250k - $290k
...operations, functions, and people.Your key responsibilitiesAs a Senior Director in Deal Management, you will be a vital member of the team... ...support your physical, financial, and emotional well-being.Are you ready to shape your future with confidence? Apply today. EY accepts...SeniorWork experience placementSummer holidayFlexible hoursEY (Ernst & Young)
New York, NY4 days ago$262.4k - $393.6k
Job DescriptionRole OverviewThe Sr. Director, Commercial Technology Business Engagement Leader... ...roadmaps, ensuring alignment to launch readiness, in‑market optimization, and evolving... ...technology experience, including senior delivery or domain leadership roles.5+ years...SeniorFull timeSummer workRemote workFlexible hours2 days per weekVertex Pharmaceuticals
Boston, MA4 days ago$165.8k - $252.1k
...sound like you?The Opportunity with McKinstryWe are adding a Senior Director, Corporate Tax to our growing Finance and Accounting division... ...frameworks, decision rights, and escalation protocols; ensure readiness for audits and controversy; and protect the company's...SeniorLocal areaRemote workVisa sponsorshipMcKinstry Co.
Seattle, WA1 day ago$265k - $300k
Senior Scientific Director, Neurodegenerative DiseasesAre you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?Within Danaher the work our diagnostic businesses do saves lives—and we’re all united by a shared...SeniorHourly payFull timeWork at officeRemote workWork from homeWorldwideFlexible hoursNight shiftDanaher Corporation
New York, NY18 hours ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Director, Inspection Readiness. Be the first to apply!
Related searches
- ai director Remote
- director work from home Remote
- director of aviation Remote
- lifestyle director Remote
- director medical information Remote
- children's ministry director Remote
- director talent management Remote
- director of government affairs Remote
- director of automation Remote
- senior director epidemiology Remote