Global Quality Risk Lead — Hybrid (ICH Q9)
Biogen
Biogen in Cambridge, MA, is seeking an Associate Director for Global Quality Risk Management. This pivotal role focuses on developing the enterprise QRM framework and aligning with ICH Q9 standards. The ideal candidate will have strong leadership skills and at least 10 years of experience, particularly in quality risk management. The position offers a competitive salary and benefits, supporting employee well-being. #J-18808-Ljbffr Biogen
$177k - $278.08k
...Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part... ...executed on time with high quality, including major submissions... ...and strategies, including risk mitigation strategies.... ...is currently classified as hybrid following Takeda's Hybrid and...QualityRiskMinimum wageFull timeTemporary workLocal areaRemote workWorldwide$212k - $333.19k
...Takeda as a Senior Director, Global Regulatory Lead – Oncology, where you will... ...executed on time with high quality, including major submissions... ...solutions and strategies, including risk mitigation strategies.Must... ...is currently classified as hybrid following Takedas Hybrid and...QualityRiskMinimum wageTemporary workLocal areaImmediate startRemote workWorldwide$155k - $214k
...:As the Associate Director, Global Quality Risk Management, you will be at the... ...to quality excellence. Leading the charge in designing, implementing... ...is pivotal in aligning with ICH Q9 and global regulatory... ...-driven decisions.This is a hybrid role that can be based either...QualityRiskTemporary workLocal area- ...Senior Global Commercial Lead, Rare Neurology At Alexion, AstraZeneca Rare... ...tolerance on time, cost, and quality, working with functional management... ...plan for optimal virtual or hybrid sessions Run deep dives,... ...understanding of technical risks and the implications for the...QualityRiskHourly payTemporary workLocal area
$154.4k - $242.55k
...Takeda as Associate Director, Global Labeling Lead where you will be... ...Providers while minimizing the risk of write-offs. Independently... ...delivery, and adherence to quality standards. Continuous... ..."remote" following Takeda's Hybrid and Remote Work policy. Takeda...QualityRiskMinimum wageFull timeTemporary workLocal areaRemote workWorldwide- ...Advance, implement, and monitor risk mitigation plans and... ...with cross-functional partners Lead EBI/corporate compliance due diligence... ...processes Background managing global compliance initiatives... ...wellbeing benefits including high-quality healthcare, prevention and wellness...QualityRiskLocal area
$170k - $180k
...retired in accordance with global regulatory requirements... .... This is a full‑time hybrid position (3 days a week... ...Part 11, EU Annex 11, ICH Q9, ICH Q10, and FDA’s... ...retirement/archival plan, risk assessments, protocols,... ...safety, product quality, and data integrity. Own...QualityRiskFull timeWork at officeFlexible hoursShift work3 days per week$110k - $177.5k
...oversight of State Street’s global communication... ...communication surveillance and leads globally distributed teams... ...remediating financial crime risks. This role can be performed in a hybrid model, where you can... ...Capable of producing high quality and/or final work product...QualityRiskTemporary workWork at officeRemote workWork from homeFlexible hours$85 - $100 per hour
...Remote Job Description: Lead the end-to-end planning and... ...management, agency coordination, risk/issue management in close... ...data Ensure high scientific quality, alignment with medical strategy... ...simultaneous projects within a complex global matrix and align region and...QualityRiskContract workRemote work$178.5k - $257.83k
Job title: Global Regulatory Lead Location: Morristown, NJ / Cambridge, MA About the job As the Global... ...opportunities, take thoughtful risks, accept challenges, and making final decisions... ...and wellbeing benefits including high-quality healthcare, prevention and wellness...QualityRisk- ...focus on the following areas: global brand management and advertising... ...Financial Services Media Lead Accenture is looking for a dynamic... ..., responsible AI, risk management, cybersecurity and... ...deliverables and programs of the highest quality possible. Excellent communication...QualityRiskLive inLocal areaFlexible hours
$177k - $278.08k
...several innovative medicines globally. We are looking for a leader who... ...the Global Launch Excellence Lead, you will work with a Product... ...Business Unit to ensure an on‑time, quality launch. Additionally, you will... ...SPD functional tactics. Risk Management: Guide the team in...QualityRiskMinimum wageTemporary workLocal areaFlexible hours$185.37k - $308.95k
...Director, Medical Review Lead, MSRM At Agios,... ...join the Medical Risk Management... ...compliance, and high-quality safety data to support... ...partners closely with Global Safety Leads,... ...Solid knowledge of ICH and global regulations... ...remote in the US or hybrid in our Cambridge Headquarters...QualityRiskTemporary workRemote workWork from homeFlexible hours3 days per week$160k - $240k
...Delhaize USA, a division of global food retailer Ahold Delhaize,... ...brands, which also includes five leading omnichannel grocery brands -... ...value. Our flexible/hybrid work schedule includes 3 in-person... ...to guide decisions on scope, quality, risk, and total cost of ownership....QualityRiskFull timeWork experience placementWork at officeRemote workFlexible hours- Amentum is a global leader in advanced engineering and innovative technology... ...across all 7 continents. Lead, Supplier Performance & Global... ...that drives innovation, risk resilience, operational excellence... ...KPI architecture (OTIF, quality, cost, service, ESG, innovation...QualityRiskHourly payContract workLocal areaRemote work
$185.37k - $308.95k
...Director, Medical Review Lead, MSRM Who we are At... ...join the Medical Risk Management... ...compliance, and high-quality safety data to support... ...partners closely with Global Safety Leads,... ...Solid knowledge of ICH and global regulations... ...remote in the US or hybrid in our Cambridge...QualityRiskTemporary workRemote workWork from homeFlexible hours3 days per week- ...STANLEY Morgan Stanley is a leading global financial services firm providing... ...role is part of Parametric's hybrid working model, which includes... ...of a consistent, high-quality client service experience across... ...efficiency, and reduce operational risk Partner with technology and...QualityRiskContract workTemporary workWork at officeRemote workWorldwide3 days per week
$346k
...the Vice President, Global Pharmacovigilance... ...Pharmacovigilance and risk management... ...Vice President will lead and provide medical... ...ensure delivery of high-quality pharmacovigilance services... ...regulations, ICH Guidelines, EU GVP... ...you to apply. #LI-Hybrid #LI-ES1 This position...QualityRiskFor contractors$160k - $220k
## Associate Director, Global Labeling LeadApplyremote type: Hybridlocations... ...documents are of high quality and compliant for the safe and... ...the labeling strategy, leading the development and update of... ...product claims representing the risks and opportunities to the project...QualityRiskTemporary workLocal area$150k - $200k
Medical Writing Lead, Global Clinical Operations, Orion Pharma Cambridge... ..., United Kingdom and 3 more (Hybrid) Job Description Orion... ...regulatory submissions, ensuring quality and compliance through leadership... ...and ensure alignment with ICH, GCP, and internal SOPs. Partner...QualityWorldwide- ...Site and Monitoring Health Lead (SMH Lead) will apply... ...monitoring to safeguard the quality of clinical trial... ...but not limited to site risk analysis, site contacts,... ...Good Clinical Practices (ICH-GCP) regulations Leads... ...Remains current with global regulatory requirements,...QualityRiskLocal areaRemote work
$316k
...Medical Safety and Risk Management will oversee... ...within the Vertex Global Patient Safety (GPS... ..., specifically leading safety content of key... ...and Product Quality sources. Reviews... ...knowledge of GCP, ICH and Global regulations... ...Designation: Hybrid-Eligible Or On-Site...QualityRiskWork experience placementSummer workLocal areaRemote workFlexible hours2 days per week- ...Executive Director, Global Regulatory Affairs... ...where applicable, quality, clinical, and manufacturing... ...: Leads and develops a team... ...strategy, impurity risk, raw material/supply... ...development CMC (e.g., ICH Q12/Q13/Q14/Q2(R2),... ...classified as "hybrid" following Takeda's...QualityRiskRemote workWorldwide
$133.5k - $192.83k
...Experience Strategy & Research Lead ~ Location:... ...resources and mitigating risks under tight deadlines.... ...strategist at a large global enterprise experience,... ...benefits including high-quality healthcare, prevention... ...#LI-SA #vhd #LI-Hybrid Pursue progress...QualityRiskFor contractorsShift work$216k - $324k
...Manufacturing Technical Sciences Quality Assurance (Hybrid) page is loaded##... ...identifying quality risks and mitigations... ...programs.The role will lead a team of process and... ...Knowledge/Skills*** In-depth global regulatory agency... ...therapy and/or Biologics (ICH/EU/FDA/etc.).* Quality...QualityRiskSummer workRemote workFlexible hours2 days per week3 days per week$154.4k - $242.55k
...Lead, Contract Management As a member of Takeda... ...types, delivering high-quality, timely contract solutions... ...complex or high-risk decisions to leadership... ...work. Certified as a Global Top Employer, Takeda offers... ...currently classified as "hybrid" in accordance with...QualityRiskMinimum wageOngoing contractFull timeContract workTemporary workLocal areaRemote work$150k - $180k
...& Response - Blue Team Lead New York or Boston KKR is a leading global investment firm that offers... ...to creating high-quality, impactful solutions that... ...week. KKR operates in a hybrid environment today; however... ..., clearly communicating risk, impact, tradeoffs, and...QualityRiskWork at officeLocal area$146.2k - $261.4k
...Research Lead - AI Cyber Testing & Evaluation RAND's Center... ...(CAST), part of the Global and Emerging Risks (GER) Division conducts cutting... ...built on our commitment to high-quality, rigorous analysis and objectivity... ...and Boston, MA. We offer a hybrid work arrangement, combining...QualityRiskWork experience placementRemote workWork from home$94k - $150k
...Global Supplier Quality (GSQ) QMS Leader (Global) We are seeking an experienced leader to define and... ...medical device environment. This role will lead cross-functional programs focused on AI... ...validation, lifecycle management, and risk control. Drive global harmonization...QualityRiskFull timeWork at officeLocal areaWork visaRelocation package3 days per week$115k - $140k
...work alongside the world’s leading experts across risk, reinsurance and capital, people... ...improvements. This is a hybrid role that requires 3 days... ...workstreams and ensure quality of deliverables. Lead... ...business of Marsh (NYSE: MRSH), a global leader in risk, reinsurance...QualityRiskMinimum wageWork at officeLocal areaRemote workFlexible hours3 days per week1 day per week
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