Global Quality Risk Director, RBQM & Study Integrity
Biogen Inc
Biogen is seeking a Manager RBQM to coordinate cross-functional risk management and central monitoring for assigned trials, ensuring compliance with ICH GCP E6 requirements. You will guide study teams on risk mitigation and data integrity, maintaining RBQM systems and providing clear risk communication. Responsibilities include leading PRA/iRMP, KRIs/QTLs, and stakeholder training, while ensuring regulatory readiness and high-quality safety data across programs. #J-18808-Ljbffr Biogen
- The Manager RBQM reports into the Clinical Operation... ...cross-functional risk management and central... ...mitigation guidance to study teams, ensuring consistency... ...patient safety and data integrity. Summary of Key Responsibilities... ...process, 'Critical to Quality' elements, safety, and...SuggestedLocal area
$155k - $214k
About This Role: As the Associate Director, Global Quality Risk Management, you will be at the forefront of Biogen’s commitment to quality excellence... ..., including 5+ years leading QRM and/or QMS process integration. Demonstrated experience in implementing ICH Q9-aligned...SuggestedTemporary workLocal area$169.22k - $253k
The Associate Director, Risk Based Quality Management is responsible for... ...and optimizing RBQM frameworks across the... ...model that aligns with global regulatory expectations... ...and risk assessment to study conduct oversight and... .... Champion the integration of digital tools, analytics...SuggestedContract workTemporary workWork at officeLocal areaFlexible hours$160.6k - $240.8k
## Associate Director, R&D Quality Regulatory & Risk IntegrationApplylocations: Boston, MAtime type: Full timeposted... ..., R&D Quality Regulatory & Risk Integration is responsible for establishing,... ...Quality. The role partners closely with Global Regulatory Intelligence &...SuggestedSummer workRemote workFlexible hours2 days per week$160.6k - $240.8k
...Position Summary Associate Director responsible for... ...and maturing the R&D Quality Regulatory Intelligence... ...assessment, and governance integration. Translate regulatory... ...RDQ quality risk insights, recommendations... ...trends, and emerging global expectations. Pay/Compensation...Suggested$90k - $115k
Associate Director, Global Quality (R&D) Pay Range: $90,000.00 - $115,000.00 per... ...vendor oversight, proactive risk governance, and continuous training... ...innovation and safeguards study subjects worldwide. What... ...applying expertise in data integrity and regulatory systems; manage...Work experience placementRemote workWorldwideShift work$160.6k - $240.8k
General Summary The Clinical Study Quality Lead (SQL), Associate Director is responsible for... ...communicating compliance risks and overseeing action plans... ...and well‑being as well as integrity and credibility of data generated... ...and applicable global regulations and guidance...Work experience placementSummer workWork at office$200k - $245k
...Scholar Rock is a late-stage global biopharmaceutical company focused... ...Support global Quality Management System (QMS) transition... ...systems are fit-for-purpose, integrated, and capable of supporting commercial... .... Build and mature a risk-based supplier quality management...- Flywire is seeking a Fraud Risk Director based in Boston, Massachusetts to architect a proactive global fraud prevention strategy. In this key role, you will lead efforts to balance customer experience with rigorous fraud prevention, oversee the fraud assessment process...
- A biotechnology organization is seeking an Associate Director, Global Quality to oversee global quality compliance across R&D. This role involves leading compliance projects, ensuring inspection readiness, and embedding quality processes. Candidates should have a strong...
- ...commerce, and commercial channels. We are seeking a Product Integrity & Quality Manager to ensure our products consistently meet consumer... ...Philadelphia, Laskohas evolved for over a century to become the global leader in air solution products. From our roots in small...Flexible hours
- Join Manulife in Boston as a leader in the Global Wealth & Asset Management Investment Operations. This role offers the opportunity to... ...-enabled operational excellence, ensuring governance and data integrity across investment operations. The ideal candidate will have over...
$160k
...Become a FlyMate! Passion, excitement & global collaboration are all core to what it means... ...a mission to deliver t... Full‑time Lead Risk Analyst, Payment Fraud at Snaplii At... ...$160,000.00 yearly Full‑time Fraud Risk Director – Flywire Ecosystem As our Fraud Risk Director...Hourly payFull timeContract workTemporary workPart timeWork at officeLocal areaRemote workWorldwideVisa sponsorship$192.6k - $260.6k
Overview Director, Clinical Quality Risk & Portfolio Oversight leads enterprise-wide quality intelligence,... ...risks, and operational trends across studies, vendors, computerized systems, audits... ...tracks high-level threats to the global clinical pipeline. Partner with inspection...Local areaRemote workShift work$90.63k - $181.25k
We are looking for a hands‑on Senior Systems Integration QA / Team Lead to oversee end‑to‑end quality assurance for our live sports video capture and multi‑angle... ...nationalities and cultures, and to build your global awareness. We value improvement and development. We...- Vertex Pharmaceuticals Incorporated is seeking a Senior Director, Global Quality Systems to lead and enhance the Quality Management System. This role requires substantial leadership experience, strong regulatory compliance expertise, and a commitment to quality culture...Flexible hours
- Columbia Threadneedle in Boston seeks a Director, Thought Leadership, responsible for developing and executing the firm's content... ...position offers extensive growth opportunities within a global team committed to quality and client success. #J-18808-Ljbffr Columbia...
- Columbia Threadneedle Investments is seeking a Director for Global Thought Leadership to shape content strategy and develop differentiated investment... ...role involves managing editorial projects and creating high-quality investment content across various formats. The ideal...Full timeWork at office
$252k - $269k
...Clinical Quality Assurance Senior Leader provides strategic... ...compliance across global clinical trials. This leader... ...implements and manages risk-based quality systems,... ...teams, sub teams, and study teams. Clinical Quality... ...subject safety, data integrity, compliance and...Local areaWorldwide$160k - $187k
...driven work style where integrity and grit drive all... ...Reporting to the Executive Director of Quality Assurance, the Senior... ...with clinical study teams to provide GCP compliance... ...and application of Global regulations and guidance... ...plans that mitigate risks to study subjects, data...Summer holidayWork at officeHome office- Korro Bio, Inc. in Cambridge, Massachusetts is seeking a Director, CMC QA responsible for quality oversight in drug manufacturing and testing. The role... ...candidate will thrive in a lean QA environment and support global clinical development programs through robust quality...
- Director, Quality Control (QC) Location: Cambridge, MA (Hybrid... ...through IND-enabling studies and early clinical development... ...raw materials under global GMP standards.... ...platforms), and LIMS and data integrity systems. Ensure... ...product lifecycle planning, risk assessments, fusion...
$245k - $335k
...people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor... ...Scholar Rock is seeking an experienced and motivated Senior Director of Global Quality Control. Reporting to the Head of Global Quality, this position...Contract work$109.2k - $174.6k
...medicine. Work with exceptional global teams on a broad pipeline and... ...worldwide.As Manager, Quality Control - Automation & Digital... ..., liquid handling platforms, integrated digital workflows, and laboratory... ..., resourcing plans, risk mitigation strategies, and stakeholder...Work at officeWork from homeWorldwide- A global biopharmaceutical company based in Boston seeks a Director, Safety Scientist to lead risk management and mentor junior scientists. Responsibilities include managing safety evaluations, preparing regulatory documents, and representing global safety at inspections...
$137.8k - $206.8k
General Summary The Senior Manager, Clinical Study Quality Lead provides study-level quality... ...Good Clinical Practice (GCP), applicable global regulations, study protocols, and Vertex... ...oversight for clinical trials, including risk‑based audit strategy, quality risk identification...Summer workRemote workFlexible hours2 days per week$156.6k - $234.8k
...Summary The Associate Director, GMP Operational Quality is responsible for oversight... ...‑being as well as the integrity and credibility of data... ...identify operational risks and collaborates with study team in development of... ...in-depth knowledge of global GMP requirements and managing...Work experience placementSummer workRemote workFlexible hoursDay shift2 days per week$71.25k - $161.7k
...around the world. We are a global healthcare leader... ...seeking a Senior Associate, Quality Control Internal... ...and support the clinical studies of gene editing medicines... ...information related to risk management, timelines,... ...Understanding of data integrity, ALCOA+ principles, and...Permanent employmentFull timeH1bWork at officeVisa sponsorshipWork visaFlexible hours- ...Description Summary Location: Cambridge MA; Internal: Director; LI#-Hybrid. This role oversees the Study Quality and Compliance team within the Toxicology line... ...Problem Solving Regulatory Compliance Researching Risk Assessments Toxicology Training Waterfall Model...
$245k - $335k
A biopharmaceutical company in Cambridge is seeking a Senior Director of Global Quality Control. The role involves leading the global QC function across an outsourced model, ensuring compliance with regulatory standards, and providing strategic oversight for QC activities...
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