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
...therapies to patients worldwide. As Executive Director, Global Regulatory Affairs CMC Early... ..., device/combination where applicable, quality, clinical, and manufacturing) to ensure... ...ensuring global CMC content quality and compliance for early development submissions and lifecycle...SuggestedFull timeTemporary workLocal areaWorldwide- ...Therapeutics in Boston is seeking a leader to oversee the global Quality Management System (QMS) ensuring its integrity and effectiveness across... ...relevant experience, and strong knowledge in GMP or GCP compliance. This role requires strategic leadership and a deep understanding...Suggested
- ...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
- ...Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing... ...anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds...SuggestedWorldwide
- ...AstraZeneca is seeking a Senior Regulatory Affairs Director in Boston, MA to lead global regulatory strategy for oncology programs. The role involves overseeing a Global Regulatory Strategy Team and ensuring competitive labeling. The ideal candidate has an advanced degree...SuggestedWork at officeRemote work
$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 employmentWork at officeWork from home$130k - $180k
...Pharmacovigilance Compliance and Oversight Manager Apr 23, 2026 $130K - $180K Galderma is the emerging... ...overseeing and maintaining the local PV quality management system (QMS) to ensure compliance with applicable U.S. and global pharmacovigilance regulations, company...Contract workTemporary workWork experience placementLocal areaShift work- ...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...
$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...$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 Improvement... ...and regulatory/quality systems relevant to drug development...Full timeTemporary workLocal areaWorldwide- Join Takeda as the Director of Global Regulatory Labeling Strategy, based in Boston, MA. You will be responsible for developing and implementing... ...and strategic regulatory thinking, focused on ensuring compliance and alignment with business objectives. Takeda offers a hybrid...
- ...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...
- 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...
- 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...
- Vertex Pharmaceuticals Inc. is seeking a Regulatory Labeling Director to lead strategic development of global labeling for marketed products, including CCDS and regional labeling (PI, PIL, IFU) across US, EU, GB, and CA. The role interfaces with FDA, EMA, and Health Canada...
- Initial Therapeutics, Inc. is seeking a Senior Director to lead global regulatory strategies in Boston. This role requires extensive experience... ...and cross-functional collaboration to ensure project compliance. Attractive compensation and benefits provided, including...
$212k - $333.19k
Takeda is seeking a Senior Director to define and lead global regulatory strategies in Boston, MA. This role requires over 12 years of experience in... ..., with a strong emphasis on regulatory submissions and compliance. The ideal candidate will have proven leadership skills,...$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- ...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...
$137k - $165k
...Overview The Senior Manager, Global Trade Compliance – Export Compliance is a... ...In partnership with the Sr. Director of Global Trade Compliance,... ...screening program, including system oversight, list updates,... ...and oversee classification quality across global teams. Prepare...Full timeTemporary workPart timeWork at officeLocal area$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- Allergan is seeking a Director of Regulatory Affairs to develop and implement global regulatory strategies to secure product approvals. The role involves leading the Global Regulatory Product Team and requires strong leadership experience within the pharmaceutical sector...
- ...About the Role 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...Full timeLocal areaWorldwide
$170k - $190k
HarbourVest Partners (U.K.) Limited in Boston is seeking a Director in the Tax Compliance function. This role involves overseeing management company tax compliance, including income tax provisions and global initiatives such as OECD Pillar Two. The ideal candidate will...Remote job- ...seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our... ...other major agencies. Ensure compliance with global regulatory requirements... ...and consultants to ensure high-quality submissions, and successful...
$177k - $278.08k
...to bring life‑changing therapies to patients worldwide. The Director Global Regulatory Affairs, Neuroscience is responsible for... ...strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible....Minimum wageFull timeTemporary workLocal areaRemote workWorldwide$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...- 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...
- Job Description Director Global Regulatory Affairs, Neuroscience responsible for developing innovative global regulatory strategies and... ...regulatory regional leads, other functions, and vendors to ensure compliance with local regulations. Oversee vendor responsibilities for...Local area
- Merck & Co. is seeking a Regulatory Affairs Headquarters Principal Scientist responsible for developing global regulatory strategies in the Vaccines and Infectious Disease therapeutic area. The candidate will lead the Global Regulatory Team, ensuring optimal timelines...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Quality Systems & Compliance Director. Be the first to apply!
- global quality manager Cambridge, MA
- director quality assurance Cambridge, MA
- quality manager Cambridge, MA
- corporate quality manager Cambridge, MA
- director of quality Cambridge, MA
- director of quality & patient safety Cambridge, MA
- quality manager healthcare Cambridge, MA
- senior manager quality engineering Cambridge, MA
- director quality assurance regulatory affairs Cambridge, MA
- director quality management Cambridge, MA

