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
- ...Job Description As Executive Director, Global Regulatory Affairs CMC Early Development you will... ..., device/combination where applicable, quality, clinical, and manufacturing) to ensure... ...ensuring global CMC content quality and compliance for early development submissions and...SuggestedTemporary workLocal area
- ...Manager, Pharmacovigilance (PV) Compliance supports the development,... ...implementation, and oversight of the global PV compliance program to... ...Safety, Regulatory Affairs, Quality Assurance, and external... ...improvement activities across the PV system. Position Responsibilities:...SuggestedLocal area
- ...Mechanical Group, Inc. is looking for an Executive Director of Regulatory Operations and Submission Management. This strategic role oversees the global regulatory processes ensuring high-quality submissions and compliance across the product lifecycle. The ideal candidate...Suggested
$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$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...Suggested3 days per week$131.9k - $161.2k
...Quality System Compliance Manager, Medical Devices As the Quality System Compliance Manager, Medical Devices, you will lead the design, implementation... ...and scale. Key Responsibilities Own and evolve the global Medical Devices Quality Management System (QMS), ensuring sustained...Temporary workLocal areaFlexible hours- ...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...
- ...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...
$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 business...Hourly payTemporary workWork at office3 days per week- ...JobRx, Inc. is looking for a Director of Global Regulatory Affairs specializing in Neuroscience. This role involves developing innovative global regulatory strategies and leading Global Regulatory Teams. The ideal candidate will have 10+ years of experience in the pharmaceutical...
- ...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...
$177k - $278.08k
...worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy... ...-to-date information and in compliance with labeling requirements... ...delivery, and adherence to quality standards. Continuous... ...principles and regulatory/quality systems relevant to drug development...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide- **Job Description**The Director, Global Regulatory Affairs Process Excellence & Transformation... ...that enhance efficiency, consistency, and quality across GRA processes. As a key member... ...priorities.* Knowledge of regulatory processes, systems, and requirements is preferred.*...Summer workRemote workFlexible hours2 days per week3 days per week
$177k - $278.08k
...Initial Therapeutics, Inc. is seeking a Director Global Regulatory Affairs in Boston. The successful candidate will develop global regulatory strategies and lead complex projects within the Neuroscience Therapeutic Area. Candidates should possess over 10 years of experience...$238k - $374k
...JobRx, Inc. is seeking an Executive Director of Global Regulatory Affairs in Boston, MA. This leadership role requires over 20 years of industry experience, with significant expertise in regulatory submissions for medical devices and combination products. You will oversee...- ...A leading security technology firm in Massachusetts is looking for a Director of Global Product Compliance. This director-level role demands ownership of regulatory compliance for hardware products globally. The right candidate will create a compliance framework that aligns...
$270k - $330k
...Position Overview The Senior Director, Global Regulatory Affairs, Oncology is accountable for providing regulatory strategic leadership... ...all activities are conducted in line with Ipsen’s ethics and compliance policies. Knowledge & Experience (Essential) Minimum 15 years...Temporary workWorldwideFlexible hours- ...Massachusetts, is seeking a Regulatory Affairs leader to oversee global regulatory strategy for medical devices and drug-device... ...role requires extensive experience in regulatory submissions and compliance with FDA and EU MDR regulations. Applicants should possess an advanced...
$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 areaRemote workWorldwide- ...YouTube, LinkedIn and Tik Tok. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is... ...interface with the AST and supporting teams. Ensures compliance with global regulatory requirements. Manages compounds through...Temporary workLocal areaWorldwide
- ...data integrity, and regulatory compliance, supporting life sciences... ...worldwide. We are seeking a Head of Quality & Regulatory Compliance (QRC)... ...and services align with global regulations and standards relevant... ...g., 21 CFR Part 11, Computer System Validation, ICH GCP, HIPAA,...Work at officeWorldwide
$245k - $300k
Merida Biosciences in Cambridge, MA is seeking a Sr. Director, Regulatory Affairs to lead and execute global regulatory strategies. The ideal candidate will oversee health authority interactions, regulatory submissions, and strategic guidance for innovative therapeutics...- 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...
- ...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...
- ...A leading global biopharmaceutical company is seeking a Director of Global Regulatory Affairs. This role is pivotal in developing innovative regulatory strategies... ...teams, managing FDA submissions, and ensuring compliance across multiple projects in a hybrid work environment...
$137k - $215.27k
...patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry... ...probability of regulatory success and regulatory compliance.Ability to draw from precedents and... ..., Analytical Development, Production, Quality Assurance can be considered.Understanding...Minimum wageTemporary workLocal areaImmediate startRemote workWorldwide$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- ...IPSEN is seeking a Senior Director, Global Regulatory Affairs, Oncology to provide regulatory strategic leadership and implement activities across assigned regions. The ideal candidate will have extensive experience in managing complex global projects and a proven track...
- ...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
- ...Vertex Pharmaceuticals Inc (US) is seeking a Director for Global Regulatory Affairs Process Excellence & Transformation in Boston, MA. This... ...operational excellence initiatives, driving efficiency and quality across the Global Regulatory Affairs processes. The ideal candidate...
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