Head of Clinical Quality & GCP Excellence
$190k - $234kCellectis
A leading biopharmaceutical company in Raleigh, NC is seeking a Director of Clinical Quality Assurance to lead the clinical QA function. The role involves oversight of GCP compliance and the development of quality frameworks ensuring regulatory compliance. Candidates should have a strong background in GCP, with over 12 years in the industry and specific experience in biological therapies. The compensation range is $190,000 - $234,000, and the position may require travel up to 10% of the time. #J-18808-Ljbffr Cellectis
$112k - $153k
...distance to Raleigh, NCThe QA Manager, GCP is responsible for: Ensuring quality oversight and quality assurance... ...program risk assessment Support clinical studies-related activities from a... ...responsibilities:Ensure GCP audit management excellence of the end-to-end audit management...SuggestedTemporary workLocal areaFlexible hours- ...Head of Quality About the Company Global pharmaceutical manufacturer focused on products used in healthcare markets worldwide.... ...continuous improvement, and fostering a culture of operational excellence. This role involves leading quality functions that support commercial...SuggestedWorldwide
- ...LinkedIn, X, Instagram, and YouTube.WHAT WE ARE LOOKING FORThe Site Head of Quality has the primary responsibility for overseeing the Quality... ...in direct interaction with FDA personnel during inspections.Excellent written and verbal communication skills.Highly motivated...SuggestedLocal area
$112k - $153k
...to Raleigh, NC. The QA Manager, GCP Is Responsible For Ensuring quality oversight and quality assurance and... ...program risk assessment Support clinical studies-related activities from a... ...Responsibilities Ensure GCP audit management excellence of the end-to-end audit management...SuggestedTemporary workLocal areaFlexible hours- The Director, Clinical Quality Assurance is primarily responsible for establishing and leading... ...oversight of Good Clinical Practices (GCP) activities to ensure compliance with FDA... ..., managers, and cross-functional teams.Excellent organizational skills with attention to...SuggestedTemporary workWorldwide
$138.6k - $257.4k
...Morrisville, NC Join Novartis as our QA Compliance and Systems Head and help shape the quality foundation that enables the delivery of medicines to... ...of compliance, continuous improvement, and operational excellence while ensuring inspection readiness and supporting the...Worldwide- Hopscotch Primary Care in the United States seeks a Manager, Operations Excellence to lead the design and execution of learning and development initiatives that enable our teams to deliver exceptional patient care. You will build and scale Hopscotch's learning ecosystem...
- Grifols is seeking a Vice President of Quality to manage all quality assurance and compliance functions at their Therapeutics site in Clayton, North Carolina. This role involves directing quality policies, ensuring compliance with GMP regulations, and overseeing a large...Worldwide
$186.49k - $278.88k
...collaboration with the Senior Director of Clinical Management, the Director is... ..., Good Clinical Practices (GCP), and Otsuka SOPs, within... ...area to optimize scientific quality/innovation of clinical study design... ...suite of programs (Word, Excel, PowerPoint, and Outlook). Good...Full timeContract workTemporary workLocal areaRemote workWorldwideFlexible hours- ...preference for candidates near Durham, NC. This senior position sits within Fortrea’s Global Quality Assurance organization, responsible for regulatory expertise, hosting complex GCP audits and inspections, and driving global quality initiatives. The role serves as...Remote job
- ...company maintains a portfolio of clinical programs across a range of... ...inspection-ready, high-quality clinical development from first... ...initiatives* Working knowledge of GCP, regulatory requirements, and... ...clinical and safety issues* Excellent communication and executive...
- Clinical Outsourcing & Vendor Management Lead outsourcing activities... ...objectives, timelines, quality expectations, and budget requirements... .... Compliance & Process Excellence Ensure outsourcing activities... .... Maintain knowledge of: ICH-GCP guidelines FDA regulations EMA...Contract work
- Overview Job Title: Medical Director - Clinical Development (Oncology) Employment... ...management to ensure timelines, quality, and compliance with GCP/ICH guidelines. Collaborate with biostatistics... ..., and US regulatory environment . Excellent communication and leadership skills,...Permanent employmentFull timeFlexible hours2 days per week3 days per week
- Sobi is seeking a QA Manager, GCP to provide quality oversight and quality-by-design activities across GCP/GCLP, supporting audits, inspections and risk assessment of BLA/NDA/IND submissions under the global umbrella. The role entails collaboration with stakeholders across...
- BioCryst Pharmaceuticals seeks a Director of Quality Control to provide strategic and operational oversight of QC activities across small molecule, biologic, and device programs. You will lead analytical control strategies, method performance, reference standards, and investigations...Remote job
- ...Growth Roles Job Title : Clinical Data Manager – Mid-Level Location... ...Review Plan Ensure data quality and integrity in alignment... ...Strong knowledge of ICH-GCP guidelines and FDA 21 CFR Part... ...multiple priorities with excellent organizational and time management...Full timeWork at officeRemote work
$119k - $179k
...Clinical Operations Manager The Clinical Operations Manager serves... ..., including the Integrated Quality Risk Management Plan (IQRMP)... ...Files (eTMFs) to ensure full GCP compliance, regulatory adherence... ...clinical SOP development. Excellent communication skills with the...Full time- ...Job Description Join Us as a Clinical Team Manager (CTM) - Make an Impact... ...meet the customer's time/quality/cost expectations, and maintaining... ..., in compliance with ICH GCP. In accordance to project specific... ...applications such as Outlook, Excel, Word, etc. Capable of...Contract workWork at officeLocal area
- ...team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride... ...Responsibilities: Confidently displays excellent internal and external customer service.... ...successfully. Strong understanding of GCP/ ICH guidelines and FDA regulations, as applicable...Full timeRemote work
- ...Clinical Data Management Lead (Contract) Department: Clinical Employment... ...coordination, ensuring data quality, integrity, and regulatory... ...compliance with FDA, ICH-GCP, and other applicable regulatory... ...skills and attention to detail. Excellent written and verbal...Contract workTemporary workFor contractorsWork at officeHome office
- Posting Information Department LCCC - Clinical Trials-426806 Career Area Research Professionals... ...this by providing leadership and excellence in the interrelated areas of patient care... ...And Experience Advanced knowledge of ICH GCP , Federal Regulations and Guidelines and...Permanent employmentFull timePart timeLive inWork at officeLocal areaWeekend workAfternoon shift
- Associate Director, Clinical Pharmacovigilance Safety - RTP, North Carolina Join a growing... ...helping shape safety governance, operational excellence, and regulatory compliance. High-Impact... ...management, SAE/AESI oversight, global GCP/GVP regulations and people leadership. Your...
$79.8k - $139.6k
...Manager, Site Contracts with Clinical Trials experience Hybrid or Remote... ...team members to excel in service delivery and compliance... ...assigned escalation channelsEnsures quality and adherence to Standard Operating... ....• Extensive knowledge of GCP/ICH guidelines and other applicable...Contract workLocal areaRemote workFlexible hours$170k - $245k
...and complex disease area.Reporting to the Head of Vonjo Medical Affairs, this... ...across Market Access, Medical Information, Clinical Development, Sales, and MarketingContribute... ...member while encouraging one another toward excellence and a shared...Temporary work- ...Pharma US Inc is looking for a driven and experienced Director of Quality US to lead and champion quality assurance initiatives. This is... .... If you're passionate about compliance & regulatory, excellence, and making a difference in the pharma industry, we want to hear...For contractorsLocal area
- ...community. In this role, you guide the clinical vision of the department and ensure our... ...mandates.You will set the standard for medical excellence across Public Health, developing,... ...health goals and expand access to high‑quality care throughout Wake County.You will also...Full timeTemporary workWork experience placementRelocation package
$260k - $295k
...pharmaceutical and biotech industries, high scientific acumen, excellent communication and analytical skills, and the ability to... ...medical affairs-led research initiatives, including US Phase IV clinical programs, post hoc analyses, and natural history studies, to address...Temporary work- ...United States- RemoteICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new... ...regulatory requirements and ethical standards in clinical research.Excellent communication and interpersonal skills, with the ability to...Full time
- POSITION SUMMARYThe Director, Quality Control provides strategic and operational leadership... ..., MSAT, AS&T, and Regulatory to support clinical and commercial manufacturing while advancing quality culture and operational excellence.POSITION RESPONSIBILITIESProvide strategic...
- ...little-to-no guidance, ensuring quality deliverables on time and... ...data management expertise to Clinical Data Management (CDM) team to... ...to SOPs as well as current ICH-GCP guidelines and other applicable... ...Office Suite including Word, Excel, and ProjectDemonstrated problem...Work at office
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