Global GMP Inspection Strategy Director
Ultragenyx
Ultragenyx is seeking a Senior Director of GMP Inspection Management to lead a global inspection readiness program across its manufacturing and testing operations, including CMOs. The role requires deep GMP compliance expertise, regulatory inspection experience, and a collaborative leadership style. The position involves on-site work with potential domestic and international travel, and reports to Global Quality/Regulatory Affairs teams. #J-18808-Ljbffr Ultragenyx
$178.1k - $244.86k
....OBJECTIVES/PURPOSELead development and advancement of Global Patient Access (GPA) strategies across programs, ensuring alignment with enterprise priorities... ...policies, and SOPs, including supporting audit and inspection readinessMonitor and manage program budgets and...SuggestedMinimum wageTemporary workLocal areaNight shift- Stoke Therapeutics is seeking a Director, Global Regulatory Strategy to lead regulatory planning across Stoke's portfolio, ensuring alignment with corporate strategy and health authority requirements. You will partner with cross-functional teams and report to the Exec...Suggested
- EMD Serono, Inc. is hiring an Associate Director of Global Labeling in Billerica, MA. This hybrid position requires 3 days in the office. The role involves ensuring globally harmonized product labeling and managing cross-functional labeling teams. The ideal candidate will...SuggestedWork at office
- Werfen is looking for a Director, Strategic Programs & Business Operations to support the COO in enhancing business processes. The role... ...excellent communication skills. This role demands travel and strategic oversight within a global organization. #J-18808-Ljbffr WerfenSuggested
$229.8k - $381.7k
...for personal development and career advancement across the globe.Your role: In your role as Global Program Head (GPH), you hold final accountability for the overall vision, strategy, execution, and development deliverables of one or more highly complex and/or partnered...SuggestedFlexible hours3 days per week- ...ready to meet you.MCR is a fast-growing global company headquartered in McLean, VA that... ...PM and staff at major program reviews, inspections, conferences, program evaluations and major... ...Integration (HSI) team and Acquisition Strategy teamREQUIREMENTSBA/BS degree and 15...For contractorsWork at office
$165.1k - $247.7k
...applicants must be eligible to work in the US. Your Role:As the Director of Global Strategic Projects, you are responsible for the... ...0b USD Life Science sector. Reporting to the Head of Global Strategy and Market Intelligence, you will independently seek out and...Work at officeLocal areaImmediate start- Werfen is seeking a Director of Strategic Programs & Business Operations to support the COO... ...Hemostasis and Acute Care units and global Technology Centers. The role requires a... ...’s degree (MBA preferred), 10+ years in strategy or operations within regulated industries...
- ...Moderna, Inc. seeks a Director of Regulatory Strategy to lead global regulatory programs across rare, autoimmune and oncology portfolios, shaping plans for US and international markets. You will coordinate cross-functional teams, negotiate with health authorities, and...
$134.2k - $202.2k
...: Sarah EllisThis information is for internals only. Please do not share outside of the organization.Your Role:The Associate Director of Global Labeling / Labeling Product Lead (LPL) ensures globally harmonized product labeling in close collaboration with cross-functional...Local areaImmediate startWorldwide- GlaxoSmithKline in the United States seeks a Senior Director, Global Regulatory Strategy - Oncology to lead regulatory strategies for asset development and lifecycle plans. The role collaborates with Early Development, Clinical, Safety, and Commercial teams to shape submissions...
- Moderna, Inc. seeks a Director of Regulatory Strategy to drive regulatory plans for select programs within rare, autoimmune, and oncology portfolios. The role is a strategic leadership position within Global Regulatory Science, shaping submissions and advising on regulatory...
- Pfizer is seeking a Global Medical Evidence Strategy Lead for the COVID-19 vaccine franchise. The role focuses on epidemiologic methods, real-world evidence, and rigorous study design to support regulatory submissions and public health needs. Responsibilities include leading...
- AstraZeneca GmbH is seeking a Strategy and Commercial Executive Director for Cell Therapy Strategy and Commercial. You will shape end-to-end strategy across a defined indication, lead global commercial initiatives, and partner with Therapeutic Areas on clinical strategy...
$200k - $300k
A biopharmaceutical company in Cambridge is seeking a Director or Senior Director of Regulatory Strategy. This role involves developing and implementing global regulatory strategies for clinical programs and leading interactions with regulatory authorities. Candidates should...- Moderna, Inc. is seeking a Director of Regulatory Strategy to lead global regulatory plans for assigned programs in rare, autoimmune and oncology portfolios. You will shape strategy, communicate risks and opportunities, and negotiate with health authorities in the US and...
- EMD Serono, Inc. in Massachusetts is seeking a Global Program Head to guide complex, partnered global programs from vision to delivery... ...development, regulatory, and commercial functions to shape strategy and ensure program success. The role will require advanced scientific...
- ...Role: As Associate Director, AS&T Projects & Strategy, you will play a key role... ...Good Manufacturing Practice (GMP), as well as compendial... ...intercultural, cross-functional, and global team environments. •... ..., such as Pre-licensing Inspection (PLI) readiness, BLA...Hourly pay
- AbbVie is seeking a Director Regulatory Affairs Global Regulatory Lead (GRL II) in Cambridge, MA. This role entails developing and implementing global strategies for product approvals while leading the Global Regulatory Product Team (GRPT). The ideal candidate will possess...
$167k - $300.7k
The Role:The Director, Training Strategy & Process Enablement is responsible for the strategic design,... ...operational excellence, compliance, inspection readiness, and workforce effectiveness... ...Quality Management System (QMS) programs, global policies, change controls, and...Permanent employmentFull timeFor contractorsWork at officeWork from home$187k - $253k
...Overview:The Director of Technical Operations and Quality (TOQ) Strategic Sourcing has responsibility... ...ecosystems and developing sourcing strategies that support programs from early... ...Human Resources, and other peers within the Global Strategic Sourcing organization....Full timeContract workTemporary workLocal areaFlexible hours$134.2k - $202.2k
...culture, presenting great opportunities for personal development and career advancement across the globe. Your Role The Associate Director of Global Labeling / Labeling Product Lead (LPL) ensures globally harmonized product labeling in close collaboration with cross‑...Local areaWorldwideFlexible hours- Takeda's Plasma-Derived Therapies (PDT) R&D Organization in Cambridge, MA is seeking a Global Regulatory Labeling Strategy Lead (Associate Director) to steer labeling strategy across US and EU. You will work with Clinical, Pharmacovigilance, Legal, and Commercial teams...
- Charles River Development, a State Street company, seeks a Chief Product Officer to lead global product strategy across the Alpha Platform and client services. You will oversee product management and product marketing, partnering with the CTO and Sales to drive market adoption...
$167k - $300.7k
...The Role:Moderna, Inc. is seeking a Director of Regulatory Strategy to support select programs within the rare, autoimmune and oncology portfolios... ...markets. The Director will be a strategic leader within Global Regulatory Science, responsible for developing and executing...Permanent employmentFull timeWork at officeWork from home$178.5k
Posting Description MANAGING DIRECTOR, GLOBAL STRATEGIC ALLIANCES, Computer Science and Artificial Intelligence, will establish the goals, strategic vision, structure, business models and organization of the Alliances department for CSAIL; develop the department’s budget...Full timeVisa sponsorshipNight shift$232.5k - $335.83k
...Job title: Head of Strategy and Management Office, Global Clinical DevelopmentLocation: Swiftwater, PA, Waltham, MAAbout the Job As Head of Strategy and Management Office within our Global Clinical Development team, you'll lead the transformation of how we deliver our...Full timeWork at office- ...process control, combining global scale with an expanded portfolio... ...interconnects; macro defect inspection of wafers and packages;... ...management and communication strategies for major initiatives.Oversee... ...U.S. Department of State - Directorate of Defense Trade Controls. As...Permanent employmentFull timeWork at office
$107.5k - $204.5k
...world. Join us and help shape the future of aerospace and defense.As a Material Program Manager (MPM), you will be accountable for all Global Supply Chain (GSC) activities on Global Patriot International Programs. This is a high-profile and high-impact assignment, and the...Contract workTemporary workWork experience placementWork at officeRemote workRelocation packageFlexible hours$210k - $245k
Ipsen is seeking a Director, Global HR Business Partner in Cambridge, MA. You will drive people strategies aligned with business priorities and foster a strong culture of collaboration. The role involves guiding senior leadership and evolving organizational practices based...
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