Director, QA Operations - GMP Oversight & Inspections
Cytokinetics
Cytokinetics, a leader in cardiovascular biopharmaceuticals, seeks a Director, QA Operations to oversee QA for DS/DP manufacturing, testing, and lifecycle management across CMOs and labs. You will lead a team, ensure GMP compliance, and act as a strategic partner with regulatory affairs and manufacturing teams. The role requires extensive experience in pharmaceutical QA, inspection readiness, and global regulatory knowledge, with the ability to drive continuous improvement and quality excellence #J-18808-Ljbffr Cytokinetics
$182.07k - $235.62k
...generations to come. The Associate Director, Quality Assurance - GMP Operations provides senior Quality... ...and direct quality oversight of Manufacturing and... ...Demonstrates in-depth knowledge of QA principles, concepts,... ...during regulatory inspections and internal audits, including...SuggestedFull timeContract workFor contractorsLocal area- ...Reporting to the Head of Global QA Operations/QP, the Director, QA Operations is... ...leading Quality Assurance oversight of all Drug Substance (DS)... ...quality events, and approval of GMP quality system records.... ...internal lead SME during inspections for manufacturing and testing...SuggestedContract work
$232k - $283k
...of patients with both common and rare diseases. As an Oversight Director, Clinical Operations supporting an asset spanning our CKD and PKU... ...management, resource planning, financial oversight, and inspection readiness across your assigned asset. In partnership...SuggestedContract workInterim role- ...Gilead Sciences Inc. in Foster City, CA is seeking an Associate Director, Quality Assurance – GMP Operations to provide senior QA leadership and oversight of Manufacturing and QC across the product lifecycle. You will drive GMP compliance for a new state‑of‑the‑art...Suggested
$157.59k - $203.94k
...Manager Quality Assurance - GMP Operations at Gilead, you will provide... ...leadership and direct quality oversight of Manufacturing and Quality... ...in-depth knowledge of QA principles, concepts, industry... ...laboratory.Participates in site inspection readiness activities and...SuggestedFull timeContract workFor contractorsLocal area$232k - $283k
...common and rare diseases. As Director of Clinical Operations, you will serve as Study... ...SET), combining strategic oversight with hands-on execution to... ..., and maintain continuous inspection readiness. The successful... ...partnership with Quality Assurance (QA). Collaborate with QA...Interim role$210k - $250k
Director, Drug Safety & Pharmacovigilance Operations The Director, Drug Safety & Pharmacovigilance (DSPV) Operations,... ...systems, quality and compliance, inspection readiness, resource planning,... ...issues. Ensure effective quality oversight of serious adverse events and expedited...Contract workWork experience placementLocal areaRemote workFlexible hours$85 - $96 per hour
...negotiation. Partnering closely with Clinical Operations, Finance, Legal, and CRO partners, the successful... ...expectations and contracts; maintain vendor oversight documentation to support oversight expectations and inspection readiness Participate in and help manage...Contract work$190k - $210k
...drive results. About The Role The Associate Director, Clinical Operations will provide leadership and operational oversight of Clinical Operations activities to execute... ...for process and operational improvements. Inspection Readiness, Quality, and SOP Support Oversee...Full timeLocal area3 days per week$175k - $250k
...anytime, anywhere. We design, build, and operate the world’s largest autonomous logistics... ...Zipline is looking for an Sr Manager / Director of Service Operations to build and scale... ...routines, performance management, and clear inspection mechanisms. Build the training and...Local areaShift work$140k - $150k
...Manager, Pharmacovigilance Operations to join our team. You... ...safety vendor oversight and management, serious... ...position will report to the Director, Pharmacovigilance.... ...schedule Liaise with QA for CAPA activities in... ...in regulatory inspections and PV audits to ensure...Full timeLocal areaRemote workFlexible hours3 days per week$275k - $295k
...experienced and motivated Clinical Operations Lead to join our drug... ...inflammatory diseases. As the Director and Lead of Clinical... ...regulatory interactions and inspections. Clinical Trial Execution... ...experience in vendor management, CRO oversight, budget management, and...- ...business value from clinical trials data. Our operational model is exemplified through execution and innovation... ...as the DS study owner in regulatory inspections and internal quality audits. Participates in oversight of vendors and provides feedback related to clinical...Full timeContract workTemporary workWork experience placementLocal area
- ...are building the clinical and operational infrastructure to take our... ...company. THE OPPORTUNITY The Director / Senior Director of... ...activities; ensure the trial is inspection‑ready at all times Serve as... ...expertise Site Management & Oversight Oversee site activation, patient...Worldwide
$85k - $100k
...Position Summary FACES Program Operations Manager is an exciting new... ...directly to the Senior Director of Child Development. What You... ...sources. Provide administrative oversight, including but not limited... ...agencies and funders during inspections and audits. Operations and Facilities...Full timeLocal area$175k - $215k
...Senior Manager for Clinical Operations, you will serve as the operational... ...complete, accurate, and inspection-ready Trial Master Files for... ...collaborate with Quality Assurance (QA) on the development and... ...management plans and document oversight strategies. Provide guidance...$260k - $300k
...outmatch disease. About the role This is the operating leader for IT infrastructure and... ...services leadership, including 5+ years at the Director or Senior Director level. Direct... ...experience. Support for an FDA Pre-Approval Inspection or BIMO inspection in an IT or security...For contractors$110k - $155k
DescriptionNatixis Investment Managers Solutions is seeking an Operations & Oversight Manager to lead a team supporting SMA, UMA, and Direct Indexing operations. This role is responsible for developing people, building structure and accountability, and strengthening oversight...Permanent employmentTemporary workFor contractorsWork at office3 days per week- Associate Director, Clinical Operations Responsibilities / What You'll Do Independently lead global, complex... ...timelines May perform sponsor oversight site visits Oversee clinical monitoring... ...with regulatory compliance audits/inspections Experience directing/leading in...Work at office3 days per week
$176.5k - $246.5k
...Vir Bio is looking for an Associate Director, Clinical Operations, responsible for independently leading... ...timelines May perform sponsor oversight site visits Manages oversight of clinical... ...regulatory compliance audits and inspections Experience directing and leading in...Full timeWork at officeWork visa3 days per week- ...- cancer free. The role: The Associate Director, Clinical Operations will play a critical role in the planning, execution, and oversight of Dispatch’s early‑phase (Phase I/II) oncology... ...operations function scales Support inspection readiness activities and ensure trials...Contract workFlexible hours
- ...Operations ManagerKidder Mathews of California has been a leader in the commercial real... ...Manager is responsible for the day-to-day oversight and coordination of all aspects of on-... ...be performed, monthly physical property inspections, scheduled preventive maintenance work,...Contract workFor contractorsWork at office
- ...Bon Appetit **Position Title: Culinary Director** **Salary:** 130,000-140,000 **Other Forms... ...cafes. We are a restaurant company that operates in contract food service. That means you... ...operating standards. + Conduct regular inspections of kitchens, service areas, events,...Contract workWork at officeLocal areaRemote workFlexible hoursAfternoon shift
$93.74k - $115k
...documentation are submitted promptly.Supervises maintenance operations, including an organized system for tracking work orders. Promotes... ...a focus on energy conservation.Conducts quality assurance inspections as needed to uphold high service standards. Engages in various...For contractorsWork at officeLocal area$186k - $233k
...implementation of GCP systems and inspection readiness. Lead and/or... ...requirements. Act as SME for Clinical Operations GCP guidance, best industry... ...continuously improve RevMed oversight and inspection readiness... ...cross‑functionally and with QA on quality initiatives, continuous...Full timeWork at officeLocal area$263.88k - $307.86k
## Senior Director, Regulatory Affairs REMS ProgramApplylocations... ...providing regulatory compliance oversight for REMS.# **... ...A/B/C, Advisory Committees, inspections)* Manage all aspects of preparation... ...functions and partnering with operations to ensure end‐to‐end program...For contractors- ...and construction management, engineering support, project controls, cost estimating, scheduling, environmental compliance, and QA/QC oversight. Since 2001, we have supported complex public infrastructure and capital improvement programs across education, healthcare, transportation...Hourly payFull timeContract workFor contractors
- ...delivering exceptional guest experiences through outstanding service, operational excellence, and a culture of hospitality. We are seeking an... ...Oversee daily housekeeping operations, room readiness, inspections, and cleaning standards.Ensure all guest rooms, public areas,...Work at officeFlexible hoursAfternoon shift
$210.38k - $272.25k
...Description Creating Possible. Together. GILEAD Director, Facilities Operations Facilities Operations | People Leader Company... ...and portfolio optimization. Compliance, Quality and Inspection Readiness Ensure compliance with applicable regulatory...Full timeFor contractorsLocal areaWorldwide$156k - $166.4k
...an outstanding career opportunity for a Director Culinary Operations to join a leading Company located in... ...sanitation, and regulatory compliance (HACCP, GMP, FDA/USDA) ~Oversee production... ...cross-functionally with Supply Chain, QA, Engineering, Maintenance, and Commercial...Contract workTemporary workShift work
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