Global GMP Inspection Leader
Ultragenyx Pharmaceutical Inc.
Ultragenyx Pharmaceutical Inc. in Bedford, MA, is seeking a dynamic Senior Director of GMP Inspection Management to lead global inspection readiness across our manufacturing and testing network. This role shapes the program, partners with CMOs, and drives continuous improvement in regulatory inspections and quality systems. You will oversee inspection strategy, develop playbooks, and coordinate cross-functional teams to ensure readiness for FDA, EMA, and other authorities, while advancing #J-18808-Ljbffr Ultragenyx Pharmaceutical Inc.
- Ultragenyx seeks an Associate Director of Global Inspection Management to drive a comprehensive global GMP inspection readiness program. The role oversees inspections across internal operations and CMOs, ensuring proactive risk-based readiness and excellence in regulatory...Suggested
- Ultragenyx Pharmaceutical is seeking a dynamic Senior Director of GMP Inspection Management to lead the development of a global inspection readiness program. The role ensures proactive, risk-based readiness across internal operations and CMOs, directing strategic inspection...Suggested
- ...partner with IT for system improvements. The role demands 10+ years of biotech/pharma experience, strong GMP knowledge, and a track record in audits and inspections. The role is hybrid in Bedford, MA, with a move to Waltham, MA, and offers a comprehensive benefits package...Suggested
$144.5k - $195.5k
The Global Study Lead (Sr. Manager, Clinical Operations) is responsible for leading the... ...preparation for, and conduct of, Health Authority Inspections and internal QA auditsEnsure that the... ...website: About AlnylamWe are the leader in RNAi therapeutics - a revolutionary approach...SuggestedFull timeTemporary workLocal areaRemote workFlexible hours$178.1k - $244.86k
...requirements.OBJECTIVES/PURPOSELead development and advancement of Global Patient Access (GPA) strategies across programs, ensuring... ...requirements, internal policies, and SOPs, including supporting audit and inspection readinessMonitor and manage program budgets and resources,...SuggestedMinimum wageTemporary workLocal areaNight shift- CIRCOR International, Inc is seeking a Global Market Manager for Power Generation to drive growth across Industrial Pumps and Valves. The role involves managing OEM strategies, developing renewable energy markets, and ensuring alignment between business units to enhance...
- Keurig Dr Pepper is seeking a Senior Global Employer Branding Manager to shape how we attract and engage talent globally. Based in Burlington, MA, you will partner with Talent Acquisition, People, Communications, Marketing and regional teams to strengthen our EVP and drive...
$171.6k - $230.9k
EMD Serono, Inc. seeks a Director of Global Regulatory Affairs to define and execute regulatory strategy for oncology programs. This role is pivotal in ensuring compliance and timely approvals with health authorities, emphasizing a strategic, data-driven approach. Located...3 days per week- EMD Serono, Inc. is hiring an Inspection Management Lead to oversee GCP/GVP inspections for R&D projects and facilities. The role involves coordinating cross-functional teams, managing inspection preparations, and ensuring compliance with regulations. The successful candidate...
- Black Duck Software, Inc. seeks a Senior Manager, Global Payroll to lead and strengthen the company’s global payroll function for a PE‑backed cybersecurity SaaS business. You will oversee payroll execution, controls, vendor coordination, and audit readiness across Finance...Remote job
$221.6k - $305.4k
EMD Serono, Inc. is seeking a Senior Director, Global Regulatory Affairs to oversee regulatory strategy for multiple oncology programs. The role includes leading global submissions, managing a regulatory team, and aligning regional plans with program milestones. The ideal...$148.5k - $214.5k
...CMC dossier Sciences team as CMC dossier leader and you’ll contribute to the CMC... ...Dossier Sciences department within Sanofi R&D Global CMC Development organization has critical... ...consultation meetings with agency, site inspections, or written responses to Agency’s information...Full time$251.61k - $377.42k
...Global Product Leader, Late CVRM – Weight ManagementAre you an inspiring leader with extensive experience in late-stage drug development? Do you want to make a significant impact by developing life-changing medicines?At AstraZeneca, we transcend global boundaries to make...Hourly payFull timeTemporary work$100.05k - $156.49k
...This position will provide the opportunity to join a top caliber inspection team that currently works on several high-profile inspection... ...who meets the qualifications for a NBIS and NTIS inspection team leader. The primary responsibilities of this position are to lead and...Full timeLocal area- JMJ PHILLIP is seeking a Global Commodity Manager to lead sourcing strategies, supplier relationships, and cost optimization across a global supply chain. The role focuses on risk mitigation, continuity, and strategic procurement programs aligned with business objectives...
$226k - $339.7k
...This role involves driving modernization of cybersecurity capabilities, guiding emerging technologies, and collaborating with global leaders. The ideal candidate will have extensive experience in cybersecurity, strong executive presence, and a proven record in managing...$140k - $223k
...JOB DESCRIPTION Job Title Global Launch Leader Azurion Eye (Cambridge, MA) Job Description Global Launch Leader Azurion Eye (Cambridge, MA) Global lead for successful launch of Azurion Eye, our AI enabled interventional system. Your role: Lead the...Temporary workWork at officeImmediate startWork visaRelocation package3 days per week- ...seeking a Sr. Director, Assistant General Counsel to act as a senior leader within the Legal Department and a principal deputy to the GC.... ..., contracting, litigation, governance, and operations for a global public company. You will lead labor and employment, compliance,...
- ...AstraZeneca GmbH is seeking a Global Product Lead for Immunology Research and Development based in Cambridge, Massachusetts. This role focuses on driving strategy for early stage immunology programs, where you'll influence key stakeholders and lead cross-functional teams...
- ...TriNetX is seeking a Chief Commercial Officer (CCO) in Cambridge, MA. This hybrid, global role leads marketing, commercial operations, HCO network operations, and sales to drive revenue growth. The CCO will report to the CEO and engage with the Board to align strategy...
- Moderna is seeking an Associate Director, Global Regulatory Advertising and Promotion to ensure compliance across promotional materials. You will liaise with Regulatory Affairs, Legal, Medical, and Commercial teams, providing strategic guidance on advertising and promotional...
- Formlabs in Somerville, MA is seeking a senior leader to drive operations strategy and transformation for a scaling world-class supply... ...translate executive vision into scalable fulfillment systems, optimize global distribution, and lead cross-functional initiatives across...
- Ipsum is seeking a Director of Epidemiology and Real-World Evidence Sciences to lead the global evidence strategy for Ipsen’s oncology assets across the product lifecycle. You will guide RWE generation and regulatory support, collaborating with Asset Teams, Biostatistics...
- ...activities in ERP systems. • Reviews and verifies GMP documentation, including batch records,... ...functions as the on-shift operational leader responsible for coordinating... ...• Experience supporting internal audits, inspections, or quality system assessments. • Experience...Full timeWork at officeImmediate startAll shiftsFlexible hoursShift work
- Alnylam Pharmaceuticals in Cambridge, MA is seeking a leader to own global pricing and market access for its Rare Disease portfolio and select pipeline assets. You will shape strategy, partner with commercial, medical, and policy teams, and ensure consistent access across...
$202.5k - $337.5k
Global CMC Automation and Robotics Leader 2 weeks ago Be among the first 25 applicants This range is provided by Sanofi. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $202,500.00/yr - $337,500.00/yr...Full timeLocal area- Anika is seeking a Senior Complaint Specialist to manage global medical device complaints in a highly regulated environment from Bedford, MA. You will oversee intake, investigation, MDR determinations, and regulatory reporting to ensure compliant, timely, and well-documented...
- Sanofi, a leader in biopharma and AI-powered science, seeks a Global Lead for Health Ecosystem & Innovation to build external partnerships with startups, academia, and digital health players. You will shape the external innovation strategy, broker collaborations, and guide...
- ...employees world-wide. The Research Finance Manager is a senior leader at the intersection of finance, clinical operations, and sponsor... ...contracting, and financial performance across Iterative Health's global research network — overseeing a team of Budget Specialists while...Contract workTemporary workFor contractorsFor subcontractorH1bWork at officeLocal areaWork visa2 days per week
- Tulip, headquartered in Somerville, MA, seeks a senior marketing leader to own the company’s marketing strategy end to end. You will... ...strategic thinking with hands-on leadership in a fast-growing, global B2B SaaS environment. You will lead an AI-native marketing organization...
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