FDA CAPA Lead: Audit Readiness & Regulatory Strategy
Accord Technologies Inc
Accord Technologies Inc is seeking a Senior CAPA FDA Lead in Bothell, Washington. The ideal candidate will have over 10 years of experience in Quality, Compliance, or Regulatory roles within regulated industries. Responsibilities include leading FDA audit readiness activities, conducting gap assessments, and mentoring teams on FDA expectations. The position demands strong hands-on experience with CAPA management systems and regulatory compliance, ensuring effective leadership during inspections and audits. #J-18808-Ljbffr Accord Technologies Inc
- ...Remote Job Description Key Responsibilities · Lead FDA audit and inspection readiness activities across the business. · Own and present CAPA effectiveness, investigation quality,... ...presenter/interface for FDA inspections, regulatory meetings, and compliance discussions. ·...RegulatoryRemote work
$94.4k - $266.3k
...come into their own as digital leaders. Ready to find genius answers to seriously... ...understand how operational, financial, and regulatory reporting requirements translate into... ...models and reporting architectures. You lead with strategy - designing frameworks that are sustainable...RegulatoryWork experience placementLive inWork at officeLocal area- ...Attention Revenue! The Audit Division is now hiring one Lead Auditor (RA3) in Bothell,... ...audit scope and sampling strategies. Reconciling source documents... ...and work setting readiness, including: Use of auditing... ...amended. Court decisions and regulatory advisories applicable to...RegulatoryPermanent employmentWork at officeImmediate startRemote work
$175.1k - $240k
...accepted by the U.S. FDA; IM-1021, a clinical... ...Quality and Audits supports the Head of... ...Program. This role leads supplier audit management... ...quality agreements, CAPA management, and inspection readiness for GxP suppliers and... ...ready, and aligned with regulatory requirements and...RegulatoryContract workAfternoon shift$259.08k - $396.2k
...which an NDA has been accepted by the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM... ...targets.Position OverviewAs the Global Regulatory Lead at Immunome, you will be the key... ...execution of innovative global regulatory strategies for our therapeutic portfolio to maximize...RegulatoryLocal areaFlexible hours$221.2k - $387.1k
...control, and compliance & audit) and the enterprise AI... ...will own the technical strategy, architecture, and... ...contributor role: you will lead through technical... ...-, board-, and auditor-ready narrativesStrong problem... ...knowledge of compliance and regulatory standards, and...RegulatoryPermanent employmentWork at officeImmediate startRemote workFlexible hoursShift work- ...Telecommunications (TMT) Environmental Lead to provide leadership,... ..., planning, permitting, and regulatory services across the global... ...HDR’s environmental services strategy and support the delivery of complex... ...high-performing, future-ready campuses designed for reliability...RegulatoryLocal area
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- ...and Fixed Wireless Access devices. You will review OEM RF components, assess architectures, and ensure production-ready designs meet performance and regulatory standards. With 10+ years in RF engineering, you will guide cross-functional teams, influence product...Regulatory
$33 - $36 per hour
...will be doing: The Property Accountant Lead plays a key leadership role in Ad-West's... ...ensuring compliance with accounting standards, regulatory requirements, and client expectations,... ..., and leads the team through third-party audits and property onboarding/offboarding...RegulatoryHourly payFull timeCasual workWork at officeRemote work- HDR is seeking a strategic Environmental Lead for the TMT sector to guide environmental planning, permitting, and regulatory compliance for data centers and telecom infrastructure. You will lead cross-functional teams, engage major clients, and advance HDR's position in...Regulatory
- ...You Are:An experienced UKG HR Lead with a strong track record of... ...existing workflowsConducting audits to drive efficiency, accuracy,... ...hands-on experience with UKG Ready HR Core and Value Add Modules... ..., solutions and assets across Strategy & Consulting, Technology, Operations...Full timeWork experience placementLive inWork at officeLocal area
$114.75k - $150.24k
...IONQ] is the world’s leading quantum platform and merchant... ...financial health, and regulatory compliance of our... ...asset management strategies that optimize technology... ...policies and external audit guidelines. While this... ...compliance penalties. Audit Readiness: Serve as the primary...RegulatoryPermanent employmentContract workWork at officeLocal area$23.5 - $30.54 per hour
Sr. Events Lead, VIP & Guest Experiences Job Category : 08. Retail Requisition Number... ...flow, service standards, event space readiness, inventory coordination, and real-time service... ...and/or certified by state and/or local regulatory bodies. Your Compensation: $23.50 - $3...RegulatoryHourly payFull timePart timeLocal areaWeekend workAfternoon shift$212.15k - $240k
...accepted by the U.S. FDA; IM-1021, a... ...This role will lead day-to-day... ...Ensure effective CAPA management, change... ...to align with regulatory updates and... ...and Inspection Readiness Ensure external... ...prepared for GMP audits or inspections... ...and remediation strategies. Strong understanding...Regulatory- ...to take ownership of meaningful projects, learn, lead, and make an impact from day one. We’re looking... ...on integrated project design and permitting strategies. Engage directly with local, state, and federal regulatory agencies to ensure compliance and secure permits...RegulatoryContract workFor contractorsFor subcontractorCasual workWork at officeLocal area
$116k - $154k
...As the Sr. Compensation Strategy Manager, this role will... .... This role will lead:Enterprise-wide program... ...Ensure compliance with regulatory, accounting, and internal... ...preparation of executive‑ready materials for leadership... ...restructuring). Maintain audit‑ready documentation...RegulatoryTemporary workWorldwideRelocation package- Google Cloud is seeking a Senior Product & Business Strategy Leader to own monetization for Google Cloud products and services, including pricing, bundling, and offers. You will drive market insights and cross-functional collaboration to scale commercial strategies across...
$75 - $80 per hour
A consulting firm is looking for a Product Manager to establish channel strategies and lead product launches in Kirkland, Washington. The ideal candidate should have over 8 years of experience in product management, focusing on consumer electronics. Responsibilities include...- ...cash, managing the annual audit, and giving the... ...organization requires. You will lead a small finance team,... ...accurate, decision-ready reporting. KEY RESPONSIBILITIES... ...Financial leadership & strategy Serve as the Executive... ...margins. Audit, tax & regulatory compliance Manage the...Regulatory
- ...the role of Transmission Line EPC Program Lead, we’ll count on you to:Assume leadership... ....Advise clients on the technical, regulatory, and execution aspects of transmission line... ...right-of-way, outage planning, and material strategy.Plan, direct, and monitor all aspects of...RegulatoryContract workFor contractorsWork at office
- ...Abatement Services, LLC is seeking an Abatement Supervisor to lead environmental abatement projects with a focus on safety and quality... ...projects while driving team performance and maintaining regulatory compliance. You will oversee air sampling, chain of custody, containment...Regulatory
- Puget Sound Energy seeks a Construction Environmental Compliance Lead to oversee environmental compliance for major capital... ...The role requires leadership in environmental risk management, regulatory strategy, and coordination with federal, state, local, and tribal stakeholders...RegulatoryFor contractorsLocal area
$250k - $325k
...President, Marketing and Commercial Strategy ~ Biotech/Pharmaceutical ~$2... ..., focusing initially on launch readiness and commercialization in the U.S. of the lead program EP-104GI for... ...ensuring alignment between Clinical, Regulatory, and Medical Affairs to support...RegulatoryContract workShift work- EvergreenHealth is seeking a Senior Recruiter to lead strategic recruitment across our healthcare system. You will partner with leaders to design and execute hiring strategies, manage full-cycle efforts, and advise on compensation and retention initiatives to build a capable...
- ...verification and validation, CAPA, root cause analysis,... ...process validation strategies using statistical... ...while meeting quality and regulatory requirements.... ...preparation for quality audits and inspections by maintaining... ...and maintain audit readiness. Collaborate with internal...RegulatoryContract workLocal area
$108.2k - $180.2k
...Construction Environmental Compliance Lead position! Specific... ...environmental stewardship, regulatory excellence, and sustainable... ...processes, compliance audits, and environmental risk mitigation... ...compliance risks, regulatory strategy, project execution issues, and...RegulatoryTemporary workFor contractorsLocal areaFlexible hours- ...Job Description The Senior Medical Lead will lead Zenitar’s US clinical organization... ...US and global clinical development strategy, PI/KOL engagement, FDA interactions, medical governance,... ...external partners. • Support regulatory submissions, including IND amendments...Regulatory
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$66.8k - $116.8k
...requirements.• Plan and conduct onsite and remote recordkeeping audits to verify OSHA compliance, identify gaps, and drive corrective... ...marketing materials and information systems to ensure compliance with regulatory agencies, federal and state laws.• Ability to quickly earn and...RegulatoryWork at officeRemote workWorldwideFlexible hours
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