Global PV QA Lead: Audits, CAPAs & Inspection Readiness
LanceSoft Inc
Alnylam is seeking a Senior PV QA Auditor to provide quality oversight for the global postmarketing PV system. The role focuses on auditing, CAPA management, deviations, and QA operations in a fast-paced environment. You will support GVP audits, inspections readiness, and vendor oversight while collaborating with cross-functional PV teams to ensure regulatory compliance and continuous improvement. #J-18808-Ljbffr Lancesoft
- ...member of the GVP QA team... ...oversight of the global post-marketing... ...worldwide PV regulations.... ...execution of the GVP audit program as... ...to Inspection activities.This... ...Manager will lead specific activities... ...analyses and CAPAs. Apply risk-based... ...inspection readiness and...SuggestedWork experience placementRemote workWorldwide
- Take the lead in shaping global pharmacovigilance quality... ...overseeing critical audit programmes,... ...Pharmacovigilance (PV) Quality Assurance... ...focuses on auditing, QA operations, and... ...analyses, and CAPAs. Support risk-based... ...Support PV/PMS inspection readiness and inspection management...Suggested
$227.9k - $308.3k
...Senior Director, Global... ...Quality Assurance Lead provides executive... ...direction for the GVP QA function and provides... ...of PV procedures, systems... ...monitoring, and inspection-readiness capabilities to... ...quality events, CAPAs, compliance assessments... ...risk-based GVP audit strategy and PV...SuggestedFull timeTemporary workLocal areaRemote workFlexible hours- Proclinical seeks a Senior Manager, Global Pharmacovigilance (PV) Quality Assurance to lead quality oversight of global PV systems from Cambridge... ...Assurance and focuses on GVP compliance, audit programs, inspection readiness, and cross-functional collaboration to strengthen...SuggestedRemote job
$200k - $240k
...critical unmet need.As a global leader in myostatin... ...to support commercial readiness and ongoing commercial... ...responsible for advancing an inspection-ready, globally... ...Position Responsibilities Lead and manage key elements... ...conclusions, and appropriate CAPA or change control...SuggestedFull timeContract work- ...This individual will lead the continued... ...clinical development, inspection readiness, manufacturing... ...CMO, CRO, CDMO, and PV partners to ensure... ...compliance with applicable global regulations and to... ...and clinical site audits. Lead external... ..., investigations, CAPAs, change controls,...
$147.5k - $221.3k
...Quality Compliance and Inspection Readiness, is responsible for... ...operational areas, assessments, audits, and evaluation of... ...and closure of CAPAs. Collaboration and Integration... ...leanProven ability to lead improvement projects... ...is a global biotechnology company...Full timeSummer workRemote workFlexible hours2 days per week- ...execution of the Quality Management System, keeping documentation, audits, and change control running reliably as the company grows. The... ...to support design documentation, supplier quality oversight, CAPA execution, AI-assisted workflows, and #J-18808-Ljbffr Pascall Systems...
$155k - $214k
...Role:As the Associate Director, Global Quality Risk Management, you... ...to quality excellence. Leading the charge in designing, implementing... ...the Director of Quality Risk Auditing & Governance, you will be the... ...for health authority inspections and external audits pertaining...Full timeTemporary workLocal area$137.8k - $206.8k
...Clinical Study Quality Lead provides study-... ...(GCP), applicable global regulations, study... ...risk-based audit strategy, quality... ...issue escalation, CAPA support, compliance... ...trend analysis, and inspection readiness. The role partners... ...direct, hands-on GCP QA experience supporting...Full timeSummer workRemote workFlexible hours2 days per week- ...supplier controls, operational audits, crisis management, and... ...contact for health department inspections and regulatory inquiries.... ...Crisis & Incident Management •Leads investigations of foodborne illness... ...incidents. •Manages recall readiness, traceability, and...Local areaRemote workFlexible hoursShift work
$137k - $215.27k
...assurance oversight of the global clinical research programs in... ...MPD) with the overall goal of inspection readiness. Serves as a Strategic... ...implements a risk-based program audit strategy, ensuring communication... ...mitigations are in place. Leads the clinical pre-approval...Minimum wageWork at officeLocal areaImmediate startNight shift- ...operations in Boston. This role leads audit strategy, vendor management, regulatory inspections, and quality events... ...to GCP, GLP, and global requirements. The position... ...processes Provide QA oversight of GLP studies... ...investigations and CAPA development Establish...Contract work
$270k - $300k
...Rock is a late-stage global biopharmaceutical company... ...the senior Clinical QA leader and trusted... ...and vendor oversight, audit strategy, inspection readiness, quality metrics, and... ...Responsibilities Lead the Clinical Quality... ...inspection findings, CAPAs, and quality issues to...$150k - $180k
...Quality Assurance Program Lead Title: Quality... ...qualify suppliers, perform audits, drive corrective... ...Management ~ Develop the QA Program Manual and user... ...client audits and NRC inspections, and report program health... ...(e.g., Exemplar Global or CQI/IRCA) ~ Familiarity...For contractors$224.9k - $404.6k
...contributing to global health... ...’s most senior QA leader across GCP... ...global regulatory inspections, and leading a high-performing... ...for deviations, CAPAs, issue management... ...and inspection readiness.Oversee the... ...laboratories and PV and clinical safety... ...of robust audit schedules, coordinating...Permanent employmentFull timeTemporary workWork at officeLocal areaWork from homeWorldwide- ...Therapeutics is seeking a Director, Corporate Quality to lead GCP/GLP QA across Clinical Development and Real-World Evidence.... ...integrity. In this hybrid role, you will drive CAPA programs, audits, inspection readiness, and continuous QMS improvements while supporting external...
$210k - $290k
...continuity, regulatory readiness, and business... ...external partners. Lead Generate’s CMC... ...performance management, audits, and issue... ...OOS/OOT results, CAPAs, change controls,... ...management, audit and inspection readiness, data integrity... ...alignment with global regulatory...Contract workFor contractorsShift work$185k - $235k
...breach assessments, CAPAs) Author key GCP quality... ...regular assessment/audits. May conduct GCP... ...remediated.Provide QA GCP review and feedback... ...regulatory submissions. Lead and participate in inspection readiness activities for... ...compliance with US and global regulations (FDA,...$185.6k - $232k
...leadership on GCP and GLP QA support and guidance... ...and implementation of CAPA plans and... ...response to quality issues, audits, and inspections.Review clinical trial... ...studies.Support inspection readiness activities for sponsors... ...Extensive experience with Global Clinical trial conduct...Full time$217.6k - $326.4k
...Operational Quality Lead and have overall... ...outcomes and real time inspection readiness. This individual... ...and teams (e.g. audit, vendor management... ...across Global Clinical Operations... ...quality strategy across QA functions (e.g. audit... ...across multiple GCP/PV with current...Full timeWork experience placementSummer workRemote workFlexible hours2 days per week- ...in responding to deviations. Lead investigation teams. • Make recommendations... ....• Assist in tracking of CAPAs through completion.• Ensure a constant state of inspection readiness ensuring that deviation and... ...during internal and external audits and ensure that assigned audit...Immediate start
$188k - $230k
...Associate Director, Quality Auditing & Compliance is responsible for leading and executing the... ...supports organizational inspection readiness, regulatory intelligence... ..., ICH guidelines, global regulatory requirements... ...and preventive actions (CAPAs) and monitor remediation...Full timeWork at officeFlexible hours2 days per week3 days per week$147.5k - $221.3k
...Pharmaceuticals seeks an Associate Director to lead inspection readiness and compliance programs for... ...regulatory readiness through audits, assessments, and CAPA management. Responsibilities... ...compliance experience ~ Knowledge of global regulatory requirements and...$188k - $204k
...anchored by its lead product,... ...management of audits, quality issues... ..., and inspections. This position... ...Pharmacovigilance (PV) oversight,... ...team members, global clinical operations... ...inspection ready, in support... ...Clinical QA oversight of... ...analysis and CAPA development to...Contract workWork at officeImmediate startRemote workWorldwide$171.2k - $256.8k
...Director, GCP & GLP QA, reporting to the Executive... ...is responsible for leading quality assurance... ...with GCP, GLP, and global regulatory... ...This role oversees audit strategy and execution... ...quality management, inspection readiness, quality events/CAPAs, and compliance processes...Contract work$156.6k - $234.8k
...Responsibilities:Lead a Quality team: primarily... ...the QA support of Change... ...investigations and associated CAPAs.Track performance... ...in inspection readiness activities and lead... ...necessarySupports internal audit or external audit... ...depth knowledge of global GMP requirements and...Full timeWork experience placementSummer workRemote workFlexible hours2 days per week$105k - $150k
...disorders. Centessa's lead investigational... ...commercial readiness. Reporting to the... ...Investigations, CAPAs, and Change Controls... ...Regulatory and Inspection Support Contribute... ...Authority inspections and audits. Maintain awareness of evolving global regulatory...Full time- ...Madrigal is seeking an experienced Senior Director, Product Quality Lead (Post-Marketing and Pharmacovigilance Quality) to guide and mature the global PV Quality function during a critical growth phase. You will oversee post-marketing safety surveillance, literature monitoring...
$184.6k - $277k
...enabling operational and site readiness. Working across... ...Quality Management System, global regulatory expectations... ...• Serve as the Quality lead for technical transfer,... ..., documentation, and inspection readiness.• Establish... ...deviations, OOS results, CAPAs, changes, and emerging...Full timeSummer workRemote workFlexible hours2 days per week
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