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
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Global Quality Director, R&D & Regulatory Readiness in Cambridge, MA vacancy
$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- ...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...SuggestedMinimum 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- ...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
- ...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
$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$196.7k - $353.4k
The Role:Moderna Therapeutics is seeking a Sr. Director of Regulatory Strategy to support oncology programs to be based in its Cambridge headquarters... ..., will be relied on to articulate clear and compelling global regulatory strategies, highlighting risks and opportunities...Permanent employmentFull timeWork at officeWork from home$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... ...leaderChallenges convention and drives innovationMakes high-quality decisions under ambiguity and pressureBuilds and develops high...Permanent employmentFull timeWork at officeWork from home- ...Pharmaceuticals Holdings, Inc. is seeking a Director/Associate Director, Quality Management Systems to lead global QMS initiatives. The role ensures inspection readiness, oversees document control, CAPA,... ...in eQMS, validation, and regulatory interactions. #J-18808-Ljbffr...
$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...- ...Moderna Therapeutics in Cambridge seeks a Sr. Director of Regulatory Strategy to lead global regulatory plans for oncology programs, guiding filings and interactions... ...knowledge, and a collaborative approach across R&D, clinical development, and business teams. You will...
Moderna
Cambridge, MA18 hours ago $196.7k - $353.4k
The Role Moderna Therapeutics is seeking a Sr. Director of Regulatory Strategy to support oncology programs to be based in its Cambridge headquarters... ..., will be relied on to articulate clear and compelling global regulatory strategies, highlighting risks and opportunities...Permanent employmentWork at officeLocal areaWork from home- Akebia Therapeutics in Cambridge, MA is seeking a Director of Regulatory Affairs - Labeling. This high-visibility role shapes global labeling strategy and partners cross-functionally to ensure labeling complies with FDA and global requirements. You will influence senior...Work at officeRelocation
- 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...
$163.5k - $281.6k
...you’re driven by purpose and ready to bring your best to work that... ...and implement comprehensive global regulatory CMC strategies for assigned... ...authoring, and review of high-quality CMC sections for all regulatory... ...development teams (e.g., R&D, Manufacturing, Quality, Clinical...Full timeFor contractorsWork at officeFlexible hoursInitial Therapeutics, Inc.
Boston, MA2 days ago$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...Full timeFor contractorsWork at officeFlexible hoursEli Lilly
Boston, MA4 days ago- 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
$190k - $210k
...paradigm and access a $15 billion global market opportunity. Our... ...single day. If you’re ready to be part of a tenacious,... ...About the Role Associate Director, Global Regulatory Affairs, Compliance As the... ...management and compliance of high‑quality regulatory submissions—...Work at officeFlexible hours2 days per week- 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
$200k - $240k
...MATechnical Operations - Quality Control /Full-Time /On... ...Rock is a late-stage global biopharmaceutical... ...experienced and motivated Director of Global Quality... ...to support commercial readiness and ongoing commercial... ...post-approval changes, regulatory commitments, and global...Full timeContract 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...
- ...well-validated targets.Reporting to the Director, R&D Quality, the Sr. Manager, R&D Quality is responsible... ...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
$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- ...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
$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- Overview Moderna Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within the oncology franchise in one... ...vaccines based on messenger RNA technology in the US and other global markets. Responsibilities Serve as the global regulatory...
- ...biotech company in Cambridge, MA, seeks an experienced Associate Director of Regulatory Strategy to lead oncology therapeutic programs. This role... ...in oncology, to ensure alignment between US and global strategies. Exceptional communication skills and leadership...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Quality Director, R&D & Regulatory Readiness. Be the first to apply!
Related searches
- director global quality Cambridge, MA
- quality regulatory manager Cambridge, MA
- training and quality manager Cambridge, MA
- director supplier quality Cambridge, MA
- director quality assurance regulatory affairs Cambridge, MA
- global quality manager Cambridge, MA
- director quality assurance Cambridge, MA
- quality supervisor Cambridge, MA
- senior manager quality engineering Cambridge, MA
- quality manager Cambridge, MA