Global Quality Systems Director — Strategy & Compliance
Vertex Pharmaceuticals Incorporated
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 across global operations. The ideal candidate will ensure effective oversight and drive continuous improvement initiatives within the Quality organization, setting strategic direction and managing stakeholder relationships effectively. Join Vertex to contribute to innovative practices within a supportive, flexible environment and explore market-leading benefits. #J-18808-Ljbffr Vertex Pharmaceuticals Incorporated
$196.7k - $353.4k
...seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader will... ...leaderChallenges convention and drives innovationMakes high-quality decisions under ambiguity and pressureBuilds and develops...SuggestedPermanent employmentFull timeWork at officeWork from home- Rhythm Pharmaceuticals, Inc. in Boston, MA is seeking an Associate Director of Benefits to lead global benefits strategy, design, and administration. The role collaborates with HR, Finance, Legal, and leadership to deliver scalable programs and an excellent employee experience...Suggested
- ...LinkedIn and Tik Tok. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II) Global Regulatory Strategy is responsible for developing and implementing... ...and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages...SuggestedTemporary workWorldwide
$167k - $300.7k
...Moderna, Inc. is seeking a Director of Regulatory Strategy to support select programs... ...a strategic leader within Global Regulatory Science,... ...policies and practices in compliance with Federal and international... ...and to ensure that report systems are maintained and compliant...SuggestedPermanent employmentWork at officeWork from home$189k - $246k
...Therapeutics, located in Boston, is seeking a Director of Regulatory Affairs Strategy. The role involves developing and executing global regulatory strategies for Phase 2 and... .... As the regulatory lead, you will ensure compliance, manage interactions with global health authorities...SuggestedRemote job$210k - $235k
Vor Bio is looking for a Director of Regulatory Strategy in Boston, MA. This role involves global leadership in regulatory strategy for developmental programs in immunology... ...closely with cross-functional teams to ensure compliance and effectively engage regulatory authorities....Remote jobFlexible hours- A global biopharmaceutical company is seeking a Director of Regulatory Affairs to lead the Global Regulatory Strategy. This role involves developing strategies for securing market approval, ensuring compliance with regulatory requirements, and mentoring team members. Candidates...
- MBX Biosciences is seeking a Director of Regulatory Affairs to lead global regulatory strategies for its clinical stage programs, including INDs and CTAs, in alignment with health authority expectations. The role provides strategic regulatory leadership across early development...
- Vertex Pharmaceuticals Inc is seeking a Director of Chemistry Manufacturing Controls (CMC) to lead a Regulatory CMC team responsible for global regulatory strategies and submissions across small molecule programs. The role emphasizes strategic leadership, Health Authority...
- ...professional to join our labeling strategy team. This team is... ...closely with labeling operations, compliance teams, and various internal stakeholders... ...Responsibilities Represent Global Labeling on product-specific... ...and help design/build systems and processes. This role is hybrid...Local area
- ...States is seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities and ensure compliance with applicable laws and guidelines.... ...hands-on role will influence regulatory strategy, prepare and manage submissions, and navigate...
- 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
- ...pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic... ...authorities like the FDA, and ensure compliance with relevant laws and regulations. Qualified... ...role is vital for supporting ongoing global clinical studies. #J-18808-Ljbffr Noema...
- ...biotechnology organization is seeking an Associate Director, Global Quality to oversee global quality compliance across R&D. This role involves leading compliance... ...strong background in project management and quality systems, preferably within the pharmaceutical industry....
$211.5k - $258.5k
...mediated diseases can live life fully. Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and... ...tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include,...Local areaFlexible hours2 days per week- ...Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within the oncology... ...RNA technology in the US and other global markets. Responsibilities Serve as... ...filing activities and ensure reporting systems are maintained and compliant....
- ...company in Cambridge, MA, seeks an experienced Associate Director of Regulatory Strategy to lead oncology therapeutic programs. This role requires... ...particularly in oncology, to ensure alignment between US and global strategies. Exceptional communication skills and...
$200k - $265k
...opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.The OpportunityLeads the global regulatory strategy, submission planning, and health authority engagement for Nemolizumab across all approved and development-stage...Full timeTemporary workWork experience placementWork at officeWorldwide- ...Takeda is looking for a Director, Global Regulatory Lead Oncology in Boston, MA. This role encompasses setting the global regulatory strategy and overseeing all regulatory activities for high... ...teams to ensure timely and quality submissions to the FDA and other agencies...
$212k - $318k
...patients faster than ever before.The Director, T1D will serve as a T1D Market... ...Gene Therapy (CGT) portfolio in the Global Value and Access Strategy (GVAS) team.The individual will be responsible... ...of both US and ex-US healthcare systems required, experience in comparable...Full timeSummer workRemote workFlexible hours2 days per week- Genetix Biotherapeutics in Somerville is seeking an Associate Director of Quality Compliance to oversee regulatory submissions and lifecycle management of GTX products. This full-time hybrid role demands strong expertise in quality assurance, with responsibilities including...Full time
- Discover International is seeking an Associate Director or Director to lead Global Regulatory Affairs on an initial contract. You will drive regulatory strategy, lead FDA interactions and manage submissions for multiple development programs, with potential conversion to...Remote jobPermanent employmentContract work
- ...Cambridge, MA is seeking a motivated regulatory professional to join their dynamic team. You will support innovative regulatory strategies and manage global submissions including IND, CTA, NDA, and MAA. The ideal candidate has a B.S./M.S. with 2+ years of experience in drug...
- ...Incorporated in Boston, MA, is seeking a Regulatory Strategy Associate Director to oversee the global regulatory strategy for development programs and marketed... ...communications, advising teams, and ensuring compliance of submissions. Vertex offers a hybrid work model and...
- Moderna, Inc. is seeking a Director of Regulatory Strategy to lead global regulatory plans for assigned programs in rare, autoimmune and oncology portfolios. You will shape strategy, communicate risks and opportunities, and negotiate with health authorities in the US and...
$200k - $300k
A biopharmaceutical company in Cambridge is seeking a Director or Senior Director of Regulatory Strategy. This role involves developing and implementing global regulatory strategies for clinical programs and leading interactions with regulatory authorities. Candidates should...- Beeline Medicines is seeking an Executive Director, Regulatory Affairs to lead global regulatory strategy for multiple programs. The role oversees IND/CTA/NDA/MAA submissions, health authority interactions, and lifecycle management. Hybrid work with on-site days is expected...
- Beeline Medicines in Boston is seeking a Director, Regulatory Strategy - Global Regulatory Lead to shape integrated global regulatory plans for early-stage immunology and inflammation programs, including lupus. You will guide development teams and coordinate across FDA...
- Monte Rosa Therapeutics, Inc is seeking a Director of Regulatory Affairs based in Boston. This strategic role involves developing and executing regulatory strategies to support global product development, particularly in immunology. The successful candidate will have at...
$153k - $185k
...leader to shape how Meltwater shows up around the world.As Director, Global Brand Strategy, you’ll be the strategic steward of the Meltwater brand... ...by humans. We remain committed to evaluating candidates fairly, consistently, and in compliance with all applicable lawsLocal areaFlexible hours
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