Global Quality Risk Lead — Hybrid (ICH Q9)
Biogen Inc
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
$154.4k - $242.55k
...Description About the Role: The Global Brand Lead, ITP (Associate Director) is... ...to ensure timely, high-quality execution of projects. How you... ...ownership; able to take calculated risk and allow others to take... ...is currently classified as "hybrid" in accordance with Takeda's...QualityRiskMinimum wageFull timeTemporary workLocal areaRemote work$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- ...Join us as a Senior Director, Global Program Lead- Neuroscience in our... ...and strong sense of the time/quality balance. Provides matrix management... ...up) or timelines change and risks to TA Unit or and Takeda... ...is currently classified as “ hybrid” in accordance with Takeda’s...QualityRiskMinimum wageFull timeTemporary workWork at officeLocal areaRemote work
- ...Pharmaceuticals, Inc is seeking a Head of Global Strategic Sourcing to lead the organization’s sourcing function.... ...strategic sourcing processes, risk management, and supplier relations. Ideal... ...in Boston, Massachusetts, under a hybrid work model. #J-18808-Ljbffr Rhythm Pharmaceuticals...Risk
$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- ...Position Summary You will lead Chemistry,... ...FDA expectations and global standards. Prepare... ...&D, manufacturing, quality assurance) to ensure... .... Identify risks and propose mitigation... ...including 21 CFR, ICH guidelines, and GMP... ...Model This role is hybrid. Employees are expected...QualityRiskLocal area
- 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
- ...translating it into a unified, governed global program. This role ensures:... ..., services, supply chain, quality) maintain ownership of execution inputs Customer Impact & Risk Oversight Maintain visibility... ...and reviews Account Enablement Lead onboarding for new account team...QualityRiskFlexible hours
- ...you will do: The Executive Director, Global Program Team Lead is responsible for providing strategic... ...necessary) as well as robust discussions of risk identification and mitigation... ...development candidate with adherence to quality, excellence and efficiency. Demonstrated...QualityRiskTemporary workWork at officeLocal areaWorldwide
$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$266.25k - $384.58k
Job Title Global Brand Lead, Oncology Location Cambridge, MA / Morristown, NJ About the Job Join... ...adapts with agility; takes calculated risks and anticipates potential issues. Strong... ...and wellbeing benefits including high‑quality healthcare, prevention and wellness programs...QualityRiskTemporary work$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$177k - $278.08k
...worldwide. Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the... ...submission types are executed on time with high quality, including major submissions (NDA/BLA/... ...solutions and strategies, including risk mitigation strategies. Takeda...QualityRiskMinimum wageFull timeTemporary workLocal areaWorldwide$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
$212k - $333.19k
...worldwide. Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part of... ...types are executed on time with high quality, including major submissions (NDA/BLA/... ...solutions and strategies, including risk mitigation strategies. Must work well...QualityRiskMinimum wageTemporary workLocal areaWorldwide- ...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
$160.6k - $240.8k
...performs advanced GCP Quality Assurance oversight... ...compliance risks and overseeing action... ...improvements. Develop and lead inspection... ...ensure compliance to ICH GCP, applicable regulations... ...R2 and applicable global regulations and... ...Flex Designation Hybrid-Eligible Or On-Site...QualityRiskSummer workWork at officeRemote workFlexible hours2 days per week$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$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$137.8k - $206.8k
...Manager, Clinical Study Quality Lead provides study‑level... ...Practice (GCP), applicable global regulations, study... ...assurance oversight, including risk‑based audit strategy,... ...Strong knowledge of ICH GCP E6(R3) and applicable... ...more. Flex Designation Hybrid‑Eligible or On‑Site...QualityRiskSummer workRemote workFlexible hours2 days per week$238k - $374k
...Executive Director, Global Regulatory Affairs... ...while ensuring product quality, patient safety and... .... Responsibilities Lead and develop a team... .... Anticipate risks and drive mitigation... .... Understanding of ICH guidance and regional... ...currently classified as “hybrid” in accordance with...QualityRiskTemporary workLocal areaRemote 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$237.2k - $372.79k
Job Description Join us as a Global Medical Lead, Dermatology in our Cambridge office. Takeda is a... ...Continuously updates knowledge of GCP, ICH guidelines, global regulations, and company... ...goals and dermatology portfolio needs. Risk management in clinical trials,...RiskTemporary workWork at officeLocal areaWeekend work$87.45 per hour
...MA or Morristown, NJ Hybrid 40 hours a week - 2 days... ...(P&HV) strategy within Global Project Teams (GPTs), developing... ..., the individual leads therapeutic area... ...preference, satisfaction and quality‑of‑life studies, real‑... ...strategies, benefit‑risk demonstration preferred...QualityRiskHourly payContract work$200k - $250k
Lead, Product Management Description: This role aligns... ...Management. Location: Hybrid (Hoboken, US | Raleigh,... ...development, content quality, measuring learning... ...direct authority, surface risks early, and tell a clear... ...About Pearson Pearson is a global learning company...QualityRiskFull time$220k - $300k
Supply Chain Lead - Critical Materials & Quantum Hardware... ...Full-Time Workspace Hybrid/Remote-eligible Job... ...Certification, you will de-risk and scale the most... ...partners Implement supplier quality systems, incoming... ...quantum hardware with global impact and defense advancements...QualityRiskPermanent employmentFull timeRemote work- Vertex Pharmaceuticals in Boston seeks a Senior Director, Quality Systems to lead quality management and systems across global operations. The ideal candidate will have a strong background in regulatory compliance, operational excellence, and quality oversight. This role...Quality
$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 AI projects... ...of Marsh (NYSE: MRSH), a global leader in risk, reinsurance...QualityRiskMinimum wageWork at officeLocal areaRemote workFlexible hours3 days per week1 day per week$238k - $374k
...Executive Director, Global Regulatory Affairs... ...while ensuring product quality, patient safety,... ...Leads and develops a team... ...strategy, impurity risk, raw material/supply... ...development CMC (e.g., ICH Q12/Q13/Q14/Q2(R2),... ...currently classified as “hybrid” in accordance with...QualityRiskMinimum wageFull timeTemporary workLocal areaRemote work
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