Global Quality Systems & Compliance Director
Scholar Rock
Scholar Rock is looking for a Director of Quality Systems and GxP Compliance in Cambridge, MA. This is a leadership role overseeing quality systems and regulatory compliance across commercial, clinical, and development activities. Candidates should have a BS/MS in a scientific discipline and 10-15 years of experience in the biotech industry, including expertise in GxP and quality systems. The successful applicant will drive quality management initiatives to prepare for commercial operations while supporting compliance and inspection readiness. #J-18808-Ljbffr Scholar Rock
$238k - $374k
...to patients worldwide. As Executive Director, Global Regulatory Affairs CMC Early Development... ..., device/combination where applicable, quality, clinical, and manufacturing) to ensure... ...global CMC content quality and compliance for early development submissions and lifecycle...SuggestedMinimum wageFull timeTemporary workLocal areaRemote workWorldwide$224.9k - $404.6k
A leading biotechnology company in Cambridge is seeking an Executive Director for R&D Quality Assurance. This leadership role involves overseeing GCP, GLP, GCLP, and GVP compliance and establishing a culture of quality and strategic risk management. Applicants should have...Suggested$193.3k - $253.3k
BeiGene, Ltd. is seeking a Director of Global R&D Compliance to act as a strategic compliance partner to science professionals in R&D. This role involves overseeing compliance policies and training, assessing risks, and ensuring adherence to regulations like the U.S. Anti...SuggestedRemote job- ...biopharmaceutical company in Cambridge, is seeking a Director of Vendor Quality Management to oversee vendor... ...industry, with a focus on vendor compliance and quality management. The candidate... ...in designing and optimizing quality systems and should be proactive in managing...Suggested
- ...patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you... ...the most up-to-date information and in compliance with labeling requirements to be provided... ..., timely delivery, and adherence to quality standards. Continuous Improvement...SuggestedLocal areaImmediate startWorldwide
$181k - $286.96k
Mass Digital Health in Cambridge, MA is seeking a Director of Quality for Internal Audit and Compliance Engineering. This leadership role is responsible for overseeing the global Internal Audit program and ensuring compliance with regulatory requirements. Candidates should...3 days per week$265k - $300k
...clinical-stage biotechnology company is seeking an Executive Director of Clinical Quality Assurance to oversee quality assurance for clinical... ...role requires expertise in GCP, GPvP, and GLP, ensuring compliance with regulations. Responsibilities include providing QA oversight...Remote work- ...to bring life-changing therapies to patients worldwide.The Director Global Regulatory Affairs, Neuroscience is responsible for developing... ...is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible....Local areaImmediate startWorldwide
$137k - $215.27k
...worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing... ...of regulatory success and regulatory compliance. Ability to draw from precedents and... ..., Analytical Development, Production, Quality Assurance can be considered. ~...Minimum wageFull timeTemporary workLocal areaImmediate startRemote workWorldwide- ...Head of Global Regulatory Advertising and Promotion About the Company Industry shaping biopharmaceutical company Industry... ...strategic direction and operational oversight for promotional compliance to ensure the alignment with commercial execution. The role involves...
$177k - $278.08k
...patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry... ...probability of regulatory success and regulatory compliance. Ability to draw from prior experience,... ..., Analytical Development, Production, Quality Assurance can be considered. Strong...Minimum wageTemporary workLocal areaImmediate startRemote workWorldwide$137.8k - $206.8k
...GENERAL POSITION SUMMARY: The Senior Manager, RDQ Compliance is responsible for leading quality assurance and compliance activities in support of... ...#LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation...Work experience placementSummer workRemote workFlexible hours2 days per week$177k - $278.08k
...patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry... ...of regulatory success and regulatory compliance. Ability to draw from prior experience,... ...Development, Analytical Development, Production, Quality Assurance can be considered....Minimum wageFull timeTemporary workLocal areaRemote workWorldwide$150.03k - $224.25k
...Provides critical support in developing global regulatory strategy, planning and execution... ...are accurate, compliant, and high-quality to allow for smooth and expeditious approvals... ...familiarity with electronic document management systems (EDMS). Competencies See OPDC...Temporary workWork at officeLocal areaFlexible hours- Akebia Therapeutics is seeking a Director of Regulatory Affairs - Labeling to lead the global labeling strategy across its portfolio. The position requires extensive... ...influence cross-functional teams while ensuring compliance with FDA regulations. The role involves...
- ...leading oncology biotech company in Boston seeks an Executive Director of Global Regulatory Affairs. This crucial role involves providing... ...strategic regulatory leadership for oncology programs, ensuring compliance, and overseeing global regulatory strategies. The ideal...
$200k - $260k
A leading consulting firm in health strategy seeks a Senior Director of Regulatory Strategy Consulting in Boston. In this role, you will utilize your substantial regulatory experience to shape global strategies and lead cross-functional teams. The ideal candidate possesses...Flexible hours$211.85k - $317.78k
AstraZeneca GmbH in Boston is seeking a Senior Regulatory Affairs Director to lead the global regulatory strategy for rare disease programs. The... ...leadership skills, and experience with regulatory documentation systems are key. This position offers a salary range of $211,854.4...$148k - $206k
A global private markets firm is seeking a Director of Tax Compliance in Boston. The ideal candidate will oversee U.S. and global tax compliance processes, lead ASC 740, and manage external advisors. Strong knowledge of private market funds and at least 10 years of tax...Remote work$211.85k - $317.78k
Job Title: Senior Director, Global Regulatory Strategy - Early Development & Business Development Location: Boston, MA At AstraZeneca, we... ...world evidence) while ensuring the highest standards of GxP compliance. Build regulatory team capabilities in due diligence and...Hourly payTemporary workWork at office3 days per week$196.7k - $353.4k
Senior Director, Global Regulatory Strategy, Oncology page is loaded## Senior Director, Global Regulatory Strategy, Oncologylocations: Cambridge, Massachusetts: Clinical Developmenttime type: Full timeposted on: Posted Todayjob requisition id: R19032**The role**Moderna...Work at officeWork from home- Initial Therapeutics, Inc. is seeking a seasoned regulatory leader to develop and execute global regulatory strategy for its oncology portfolio. The role requires extensive experience in regulatory strategy with a focus on oncology, strong stakeholder engagement, and a...
$211.85k - $317.78k
.... This is what you will do: The Senior Regulatory Affairs Director (Sr RAD), Global Regulatory Strategy, leads the development and implementation... ...information. Experience with regulatory documentation systems (e.g., Veeva). We would prefer for you to have: Multi‑regional...Hourly payTemporary workWork at officeFlexible hours3 days per week- 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...
- A leading BioPharmaceutical company seeks a Senior Director, Global Regulatory Strategy, to lead regulatory efforts for early-stage products and ensure alignment with health authority expectations. The role demands extensive regulatory experience in the pharmaceutical...
- ...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...
- ...Cambridge, Massachusetts, is seeking a Vice President of Quality to lead their quality organization. The role involves developing a quality strategy, overseeing compliance with regulations, and ensuring quality assurance systems for clinical and commercial products. Candidates...
$177k - $278.08k
...Purpose: Defines, develops and leads global strategies to maximize global regulatory... ...maintenance of programs, while ensuring compliance with applicable regulatory requirements.... ...counterparts. Accountabilities: The Director will be responsible for complex or...Minimum wageFull timeTemporary workLocal areaImmediate startRemote work$212k - $333.19k
...lasting impact on patients worldwide.Join Takeda as a Senior Director, Global Regulatory Lead – Oncology, where you will be part of the global... ...ensuring all submission types are executed on time with high quality, including major submissions (NDA/BLA/MAA)For the project(s)...Minimum wageTemporary workLocal areaImmediate startRemote workWorldwide$131.9k - $161.2k
About Us SharkNinja is a global product design and technology company, with a diversified portfolio of 5-star rated lifestyle... ...and offline, and through distributors around the world. Quality System Compliance Manager, Medical Devices As the Quality System Compliance...Full timeTemporary workLocal areaFlexible hours
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