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
- ...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
- ...patients worldwide. As Executive Director, Global Regulatory Affairs CMC Early Development... ..., device/combination where applicable, quality, clinical, and manufacturing) to ensure... ...ensuring global CMC content quality and compliance for early development submissions and...SuggestedRemote 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 work$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- ...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...
- ...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...
$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$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$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...Hourly payTemporary workWork at officeFlexible hours3 days per week- ...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...
$196.7k - $353.4k
...The role Moderna is seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader will shape regulatory pathways for novel, first‑in‑class therapeutics and drive successful global development...Permanent employment- ...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...
- ...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...
- ...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
- 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...
- ...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...
- 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...
- ...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
$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$196.8k - $295.2k
...Director, Global Regulatory Affairs Process Excellence & Transformation The Director, Global... ...that enhance efficiency, consistency, and quality across GRA processes. As a key member... ...Knowledge of regulatory processes, systems, and requirements is preferred. Experience...Summer workRemote workFlexible hours2 days per week3 days per week$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$177k - $278.08k
...worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing... ...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- ...MP Training and Recruitment is seeking a Privacy Compliance Director to oversee global privacy compliance efforts. This role involves managing a variety of vendor and asset assessments, and requires extensive experience in the privacy compliance and risk management field...
$270k - $330k
...The Senior Director, Global Regulatory Affairs, Oncology is accountable for providing regulatory strategic leadership to assigned program... ...and manage performance and all applicable processesEthics and Compliance: Be accountable for ensuring all activities are conducted in...Temporary workLocal areaWorldwideFlexible hours- ...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
- ...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...
$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- ...Initial Therapeutics, Inc. is seeking a seasoned professional for a role in Global Regulatory Affairs, focusing on Chemistry Manufacturing & Controls. The successful candidate will lead the development of regulatory CMC strategies and manage submissions critical to product...
$193.3k - $253.3k
## Director, Global R&D ComplianceApplylocations: Remote (US)time type: Full timeposted on: Posted... ...:** The Director, Global R&D Compliance will serve as the strategic compliance... ...Partner with Global Internal Audit and Quality by preparing documentation and coordinating...Hourly payLocal areaRemote work
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