- ThermoFisher Scientific (WV)
- …biopharmaceutical, and optionally, omics, markets. You will deliver high value, high quality marketing collateral to support our go-to-market strategies. You ... biopharma including, impactful customer-facing marketing collateral, sales and support trainings for product positioning to internal and external customers and… more
- AbbVie (Worcester, MA)
- …We are seeking a highly motivated candidate to join our team as the Biopharma Investigation Author. The Sr Specialist Quality Systems is responsible for ... providing quality assurance support for some or all of the following manufacturing...in as many of the following areas as possible: Quality , Regulatory , Process Sciences, Manufacturing Operations. +… more
- Astellas Pharma (Westborough, MA)
- …AIRM is headquartered in Massachusetts. Astellas is announcing a **Technical Biopharma Manufacturing Scientist I** opportunity at their **Astellas Institute for ... candidate will work closely with Process Development, Manufacturing, Engineering and Quality Assurance teams to ensure successful introduction of new processes (NPI)… more
- Kedrion Biopharma, Inc. (Melville, NY)
- …information and trends. **Other:** + Support audits conducted by clients or regulatory / agencies. + Support regulatory submissions if applicable. + ... Kedrion Biopharma is a biopharmaceutical company specializing in the...quality and production related documentation and procedures in support of internal manufacturing operations. The position advises … more
- Kedrion Biopharma, Inc. (Melville, NY)
- …repository to capture and apply insights from past project risks and mitigations. ** Regulatory Compliance and Quality Assurance** + Ensure that all capital ... Kedrion Biopharma is a biopharmaceutical company specializing in the...Collaborate with cross-functional teams, including engineering, operations, finance, and regulatory affairs, to conduct in-depth feasibility studies, risk assessments,… more
- Kedrion Biopharma, Inc. (Fort Lee, NJ)
- …adhere to agreed-upon timelines and budget, while ensuring patient safety and data quality . To support and contribute to ongoing process improvement workstreams. ... Kedrion Biopharma is a biopharmaceutical company specializing in the...assigned clinical trials to agreed timelines, budgets and data quality standards. Activities include but are not limited to… more
- Kedrion Biopharma, Inc. (Fort Lee, NJ)
- …and mailing or shipments from the site, ie new employee onboarding or offboarding, support of regulatory or quality documents, scheduling interviews, org ... Kedrion Biopharma is a biopharmaceutical company specializing in the...in this role include: + Executive and VP level support for travel arrangements, expense reports, calendar management, … more
- Catalent Pharma Solutions (Bloomington, IN)
- **We're hiring for a Senior Regulatory Affairs Specialist to support compliance and regulatory affairs in Bloomington, Indiana!** Catalent is a global, ... update facility drug master files. + Prepare accurate and quality documentation for client regulatory submissions. +...documentation for client regulatory submissions. + Provide regulatory guidance and support for development and… more
- Cardinal Health (Columbus, OH)
- …Discovery + Investigational New Drug Application + Label Expansion + State Licensing + Regulatory Training & Ongoing Support + Salvage Services Cardinal Health ... **Position Summary** For nearly five decades, Cardinal Health Regulatory Sciences' industry-trained regulatory consultants have provided expertise and guidance… more
- Merck (Boston, MA)
- …to design and implement data management systems, tools, and infrastructure to support biopharma research activities. + Identify opportunities for system ... pipeline. We are seeking a Senior Information Architect with expertise in biopharma research to support our organization's target and biomarker discovery,… more
- Lilly (Indianapolis, IN)
- …of Engineering and CSV will work across the POINT organization to provide Quality support to all Engineering activities and Computer Systems, including oversight ... life better for people around the world. **About POINT Biopharma :** POINT Biopharma Global Inc. is a...Lilly and Company. **Position Summary:** The Associate Director of Quality Engineering and Computer System Validation (CSV) is responsible… more
- Catalent Pharma Solutions (San Diego, CA)
- …Senior QA Manager include activities related to GMP (Good Manufacturing Practices) and regulatory oversight, quality support to operations and coordination ... Quality performance, Operational Excellence, continuous improvement, error reduction, regulatory compliance, and sound fiscal responsibility. The primary responsibilities… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …compliance as pertains to Catalent SOPs, regulatory , and customer requirements + Support Corporate and local Quality policies and initiatives. Support ... hiring a QA Supervisor. The QA Supervisor will provide Quality Assurance support for the Quality...of materials at Catalent-Philadelphia. Assist in the enforcement of regulatory compliance through state, FDA, DEA, CDC, and USDA… more
- Catalent Pharma Solutions (Harmans, MD)
- … Control and is the most responsible person for batch disposition. The Head of Quality will provide project guidance and support while working with customers to ... as the site's primary contact (with both customers and regulatory agencies) for the site Quality Unit....growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to… more
- Catalent Pharma Solutions (Harmans, MD)
- …Senior Management on a periodic basis. Track action items for completion + Support client projects and provide quality oversight of manufacturing operations and ... **Position Summary** The Director, Quality Systems is responsible for the management and...release of drug substance and/or final drug product to support Phase I/II clinical trials + Work with clients… more
- Cardinal Health (La Vergne, TN)
- **_Job Summary_** The Director, Quality Management provides strategic oversight, leadership and direction to the Quality function and will be accountable for the ... bulk up) business unit within the Cardinal Health Pharmaceutical Segment. **_What Quality Management contributes to Cardinal Health_** Quality Management is… more
- Randstad US (Rocklin, CA)
- …Specialist will be part of the Quality team and responsible for providing quality support for the site quality management system. This position ensures ... future products and current product and process improvements. The position may represent Quality on cross-functional teams to support business needs driving a… more
- Catalent Pharma Solutions (Bloomington, IN)
- …in compliance with GxP regulations + Possess a strong background in regulatory compliance, expertise in quality management systems and document control ... **Position Summary** The Director of Quality Systems is responsible for managing pharmaceutical ...functions ensuring alignment with company goals and objectives + Support GxP functions by developing and implementing policies, procedures,… more
- Boehringer Ingelheim (Athens, GA)
- …/ GMP standards at suppliers and contractors to meet FDA/EU and other relevant regulatory requirements, and to prevent and mitigate quality risks.As an employee ... **Description** Leads and conducts internal audits to assess the quality / compliance of current Good Manufacturing Practice (cGMP), applicable regulations, and… more
- PCI Pharma Services (Rockford, IL)
- …understanding of tasks, responsibilities, business goals, and customer demands. + Provide 24-hour support for Quality related issues either by phone or email. + ... improvement/harmonization initiatives across multiple facilities. + Ensure Performance Metrics (Safety/ Quality / Regulatory /Delivery), goals, and objectives are on track… more