- Catalent Pharma Solutions (Kansas City, MO)
- …including equipment, instruments, and software systems, as applicable. Perform support compliance activities such as risk assessments, data integrity effects, ... **Senior Validation Specialist I, BioAnalytics Computer System Validation (CSV) & Compliance ** **Position Summary:** Catalent, Inc. is a leading global contract… more
- Sumitomo Pharma (Providence, RI)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo ... Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in...with PV and cross-functional team members to manage the benefit/ risk profile of assigned products and ensure patient safety.… more
- Sumitomo Pharma (Indianapolis, IN)
- Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the US (Sumitomo Pharma America, Inc.), focused on addressing ... to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo- pharma .com or follow us on LinkedIn. **Job Overview** We are currently… more
- W. R. Grace (Columbia, MD)
- Category Manager - Pharma Chemicals and CDMO Apply now " Date:Nov 20, 2025 Location: Columbia, MD, US, 21044 Company: W. R. Grace & Co. Annual Wage Range:$103,975.20 ... Columbia, MD and locations worldwide. Job Description The Category Manager - Pharma Chemicals and CDMO is responsible for leading strategic sourcing initiatives for… more
- Ascendis Pharma (Palo Alto, CA)
- …and ready to help lead a fast-paced, global pharmacovigilance organization? Ascendis Pharma is seeking an experienced Program Safety Lead to champion safety ... excellence, drive compliance , and shape strategy across our growing portfolio. We...CA and Princeton, NJ. Come join us at Ascendis Pharma , where our core values Patients, Science & Passion,… more
- Astellas Pharma (Northbrook, IL)
- …of America), FDA, EMA, PMDA, ACCME and OIG. Is able to apply legal and compliance knowledge to Medical Affairs activities + Experience in managing large budgets ... ** Medical Affairs Global Strategic Brand Lead, Ophthalmology** Do...of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in… more
- ThermoFisher Scientific (Bedford, MA)
- …Office **Job Description** **Job Description: Director, Quality - Purification & Pharma Analytics (PPA)** **How You'll Make an Impact** Leading quality efforts ... - Develop and implement the Quality strategy for Purification and Pharma Analytics (PPA), guaranteeing consistency with Bioproduction Group and Company objectives.… more
- Ascendis Pharma (Princeton, NJ)
- …including purchase requisitions, purchase orders, and ACH funding for copay programs. Compliance and Risk Management: Ensure compliance with regulatory ... Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company...developing new and potentially best-in-class therapies to address unmet medical needs. Our culture fosters a place where skilled,… more
- Catalent Pharma Solutions (Morrisville, NC)
- …healthier lives. Catalent is dedicated to delivering unparalleled service to pharma , biotech, and consumer health customers, supporting product development, launch, ... commercial manufacturing for pMDI, DPI and Nasal Sprays. Catalent Pharma Solutions in Morrisville, NC is hiring a Senior...Patient First culture through excellence in quality and** ** compliance , and to the safety of every patient, consumer,… more
- AssistRx (Orlando, FL)
- …consultation to internal leadership, commercial teams, and clients regarding risk , opportunity, and strategic response frameworks. Cross-Functional Collaboration + ... Partner with Product, Marketing, Client Services, Compliance , and Data teams to forecast impact and align...of US healthcare delivery, financing models, reimbursement, and specialty pharma . + Proficiency with data analysis tools (Excel required;… more
- Guidehouse (Chicago, IL)
- …course of study. + 10 years of Life Sciences (Pharmaceutical, Biotech, Specialty Pharma and/or Medical Technology) consulting experience or blend of consulting & ... program design, implementation, and monitoring services to pharmaceutical, biotechnology, and medical device, companies. We support our clients across the lifecycle… more
- PCI Pharma Services (Rockford, IL)
- …the future of PCI. As a Project Engineer II - Drug Delivery at PCI Pharma Services, you will take ownership of complex technical projects that directly support the ... and develop SOPs, production line layouts, and visual diagrams. Compliance , Documentation & Validation - Support Validation during OQ...of Design Controls (CFR 820.30 / ISO 13485) and Risk Management (ISO 14971). - High proficiency in data… more
- PCI Pharma Services (Rockford, IL)
- …+ Apply engineering best practices to optimize manufacturability, reliability, and regulatory compliance . + Conduct risk assessments (eg, FMEA, pFMEA) and lead ... vendors and review project documentation to ensure timely completion and compliance with specifications. + Lead projects involving high-speed assembly and packaging… more
- PCI Pharma Services (Rockford, IL)
- …the future of PCI. **Job Title: Senior Validation Engineer - Medical Device Assembly (CDMO)** **Location:** [Rockford] **Department:** Quality **Reports To:** ... **Senior Validation Engineer** to support the validation activities associated with medical device assembly lines within a fast-paced Contract Development and… more
- Ascendis Pharma (Princeton, NJ)
- …cross-functional initiatives and influence senior stakeholders + Proven ability to manage compliance risk in a dynamic and regulated environment + Exceptional ... Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company...developing new and potentially best-in-class therapies to address unmet medical needs. Our culture fosters a place where skilled,… more
- Astellas Pharma (Westborough, MA)
- …want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around ... world. We are committed to turning innovative science into medical solutions that bring value and hope to patients...Medicine (AIRM)** is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization… more
- PCI Pharma Services (Bedford, NH)
- …Develop and recommend science-based solutions with a focus on continuous improvement and compliance . + Perform risk assessment and mitigation steps to achieve ... array of well-defined validation activities in support of cGMP pharmaceutical/ medical device contract manufacturing across multiple PCI facilities. In collaboration… more
- Ascendis Pharma (Princeton, NJ)
- …a commercial biotech or pharma environment. + Proven ability to manage compliance risk in a dynamic and regulated environment. + Exceptional analytical, ... Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company...developing new and potentially best-in-class therapies to address unmet medical needs. Our culture fosters a place where skilled,… more
- PCI Pharma Services (Bedford, NH)
- …an array of well-defined validation activities in support of cGMP pharmaceutical/ medical device contract manufacturing across multiple PCI facilities. + The ... protocols for installation, operation, performance of equipment, functional requirements, risk assessments, and IQ/OQ/PQ. + Review commissioning, qualification and… more
- PCI Pharma Services (Rockford, IL)
- …Analyst II** is responsible for overall validation project ownership of moderate risk project(s) under mild supervision. Responsible for the generation and execution ... duties may be assigned. Performs validation activities to ensure compliance with government and customer requirements. Prepares validation protocols, validation… more