Global Quality Director, R&D & Regulatory Readiness
Skills Alliance Enterprise
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 background in project management and quality systems, preferably within the pharmaceutical industry. The position offers a competitive salary and may require up to 15% travel. #J-18808-Ljbffr Skills Alliance Enterprise
$238k - $374k
...forward-looking, world-class R&D organization that unlocks... ...patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug... ..., combination product, quality, clinical, development and manufacturing... ...compliant, inspection-ready processes and documentation....SuggestedMinimum wageTemporary workWork at officeLocal areaRemote workWorldwide$212k - $333.19k
...forward-looking, world-class R&D organization that unlocks... ...worldwide.Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you... ...registration and launch readiness for high-impact oncology... ...executed on time with high quality, including major submissions...SuggestedMinimum wageTemporary workLocal areaRemote workWorldwide$90k - $115k
Associate Director, Global Quality (R&D) Pay Range: $90,000.00 - $115,000.00 per year Travel may be required. We are partnered... ...role ensures alignment with international regulatory standards while driving inspection readiness, vendor oversight, proactive risk governance,...SuggestedWork experience placementRemote workWorldwideShift work$247.2k - $334.4k
The Senior Legal Director, R&D and Regulatory Counsel is a strategic legal leader who enables efficient, high-quality decision-making on regulatory pathways... ...involving U.S. and global regulatory pathways, product... ..., inspection readiness, and human subject research...SuggestedFull timeTemporary workLocal areaFlexible hours- ...DescriptionGeneral Summary:The Associate Director, CMC Quality Compliance and Inspection Readiness, is responsible for inspection... ...and Skills:Knowledge of regulatory requirements and inspection expectations... ...InformationVertex is a global biotechnology company that invests...SuggestedFull timeSummer workRemote workFlexible hours2 days per week
$177k - $278.08k
..., we are a forward-looking, world-class R&D organization that unlocks innovation and... ...patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing &... ..., Analytical Development, Production, Quality Assurance can be considered. Strong understanding...Minimum wageTemporary workLocal areaRemote workWorldwide$238k - $374k
...the best of my knowledge.Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you looking for... ...accelerate development while ensuring product quality, patient safety, and inspection readiness.A key element of this role is advancing the use...Minimum wageTemporary workLocal areaRemote work- ...Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II) Global Regulatory Strategy is... ...related to pharmaceutical regulatory work (e.g., other R&D role or specialized training). Requires drug development...Temporary workWorldwide
- ...or Philadelphia, PA Key Responsibilities Represent Global Labeling on product-specific Global Regulatory Teams and other cross-functional product, development... ...and Operations and Supply Chain to ensure submission-ready labeling components comply with regulatory...Local area
$181k - $288k
Job TitleDirector, Quality & Regulatory- Mergers & Acquisitions (M&A)Job DescriptionThe Director, Quality & Regulatory M&A is an enterprise... ...management.Drive Day 1 readiness and Day 2 execution, partnering... ...data monitoring, and support to global market organizations.Support...Full timeWork at officeImmediate startWork visaRelocation package3 days per week$167k - $300.7k
...The Role:Moderna, Inc. is seeking a Director of Regulatory Strategy to support select programs within the rare, autoimmune and oncology portfolios... ...markets. The Director will be a strategic leader within Global Regulatory Science, responsible for developing and executing...Permanent employmentFull timeWork at officeWork from home$180k - $245k
...Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs,... ...third-party vendors and consultants to ensure high-quality submissions, and successful execution of regulatory...$163.5k - $281.6k
...driven by purpose and ready to bring your best... ...experienced and strategic Director/Senior Director, Regulatory CMC to lead and... ...compliance with global health authority requirements... ...and review of high-quality CMC sections for all... ...teams (e.g., R&D, Manufacturing, Quality...For contractorsWork at officeFlexible hours$196.7k - $353.4k
...is seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader... ...Challenges convention and drives innovation Makes high-quality decisions under ambiguity and pressure Builds and develops...Permanent employmentFull timeWork at officeWork from home- ...Pharmaceuticals Holdings, Inc. is seeking a Director/Associate Director, Quality Management Systems (QMS) to lead the global QMS scope, including document control,... ...operational execution to ensure inspection readiness and regulatory alignment. The ideal candidate will be...Work at office
- ...Companies in Cambridge, MA seeks an Associate Director to provide global, end-to-end nonclinical safety... ...the PCS authority on cross-functional R&D teams and interactions with global Health Authorities to ensure robust, regulatory-compliant safety strategies that enable...
- Treeline in Watertown, MA seeks a Head of Quality Assurance to provide strategic and operational... ...scalable QMS and governance, collaborate with CMC, Regulatory, Clinical Operations, and Supply Chain, and ensure compliance with global regulations to protect patient safety and...
- Akebia Therapeutics seeks a Director, Regulatory Affairs - Labeling to shape global labeling strategy across our portfolio. You will serve as the enterprise expert on labeling, partnering with Clinical, Medical Affairs, Commercial, Legal, Safety, and CMC to ensure robust...
- Join to apply for the Associate Director, R&D Quality role at BioSpace We are seeking a highly motivated... ...candidate will strengthen inspection readiness, harmonize processes and job aids, and... ...work. That’s why our US benefits and global well-being resources are designed to...Work from home
- ...validated targets.Reporting to the Executive Director, R&D Quality, the Sr. Manager, R&D Quality is... ...aligned with: ICH E6(R3), FDA regulations, global requirements, and GxP industry standardsInspection Readiness and Regulatory SupportParticipate in inspection readiness...Temporary workWork at officeLocal areaImmediate start3 days per week
$245k - $305k
Cambridge, MADevelopment - Global Quality /Full-Time /HybridScholar Rock is a late-stage global... ...and CMC teams to support method readiness, control strategy development, and phase... ...corporate goals, customer expectations, and regulatory obligations (FDA, EU, and other global...Full timeContract work- Associate Director, Global Regulatory Affairs, Advertising and Promotion Job Description At Takeda, we are a forward‑looking, world‑class R&D organization that unlocks innovation and delivers transformative therapies to patients worldwide. The Associate Director, Global...Full timeRemote workWorldwide
- Biogen, Inc. is seeking a Head of Global Product Quality for Biologics to lead the PDQ team and drive strategy, governance, and quality across the portfolio. The role emphasizes regulatory alignment, audits, and continuous improvement across an international matrix. Hybrid...
$142.5k - $256.5k
The Role:The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory... ...responsible for preparation of CMC and Quality related agency correspondence and... ...projectsReview documents for submission-readiness, to ensure that all submissions...Permanent employmentFull timeWork at officeWork from home- GLOBAL TRADE COMPLIANCE MANAGERWhy join Aptiv? You'll have the opportunity... ...greener, and more connected. Ready to shape the future of... ....• Support customs audits, regulatory inquiries, and trade-related... ...Customer Focus - Delivers high-quality support to internal...Full timeTemporary work
- # Director, Portfolio Strategy - Global InitiativesFlagship PioneeringDirectorVenture CapitalHealthcare, Biotech... ...a differentiated BioMedicines R&D portfolio from early discovery through... ...clinical development and commercialization readiness.The role partners closely with...
$172k - $236.5k
...differentiated BioMedicines R&D portfolio from early discovery... ...development and commercialization readiness. The role partners closely... ...R&D, Clinical Development, Regulatory, CMC, Finance, Commercial,... ...initiatives with the Head of Global Initiatives and SVP, Global Initiatives...- Alnylam Pharmaceuticals is seeking a Senior Legal Director, R&D and Regulatory Counsel responsible for providing strategic legal counsel on regulatory pathways and product development. This role supports key pipeline assets and collaborates across teams to manage legal...
$251.77k - $307.72k
...Digital Compliance Senior Director to lead transformational change within our quality compliance... ...maintain a comprehensive global QMS governance framework... ...ensuring compliance with regulatory requirements, industry... ...expert for inspection readiness and directly interact...Full time- ...DescriptionGeneral Summary:The CMC Quality Compliance Director is responsible for inspection readiness and compliance of internal and... .... Monitor and interpret cGMP regulatory guidelines and trends in the... ...Skills:Expert knowledge of global GMP requirements and experience...Full timeWork experience placementSummer workRemote workFlexible hours2 days per week
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