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- Branchburg, NJ

Job Description: QA/QC & Compliance Manager Responsibilities: Reporting to the VP of R&D, this position will oversee all operations to comply with the FDA, USDA, customer and company quality and food safety system standard. Specific responsibilities include:Design and implement food safety systemsMaintain and monitor all quality and food safety systems (GMP, Allergen Policy, Pest Control, Maintenance Plan etc.)Train all employees in food safety principlesAchieve SQF Level III....


Top Pharmaceutical company is looking for a Senior Clinical Data Manager Contractor in their Madison, NJ office one year contract and can renew up to 4 years at a time, benefits included Description: Position Summary The Senior Manager, Clinical Data Management is responsible for leading internal and outsourced Clinical Data Management activities in support of Clinical Research studies, managing the definition of Case Report Form (CRF) requirements, creation of the Data Management Plan,....


Principal Scientist GLOBAL PHARMACEUTICAL COMPANY is hiring a Technical lead to design and execute analytical related aspects of pharmaceutical drug product development. Has broad and in-depth understanding of analytical techniques to support testing of a range of small molecules and macromolecules. Understanding of biomolecules and bioanalytical techniques including test methods to support clinical studies such as pharmacokinetics studies is desirable. Has method development/validation....


Join a Global Company as the strategic North American (NA) Team Leader supporting Analytical/ Synthesis (Methods Development); Product Metabolism, Product Safety (registration); and Regulatory Compliance (EPA). Participate on the Global Leadership Team while developing a challenged, problem-solving analytical team responsible for performing/ delivering scientific studies to ensure a sustainable product safety and registration success. The successful candidate will have a strong background in....

- New Haven, CT

Overview Our client is seeking a Product Quality Assurance Team Leader who will provide quality oversight of new device and combination clinical products from introduction throughout the product and design control lifecycle. As the product quality expert, the Product Quality Engineer will build the strategy to proactively minimize product quality and design control risks through early detection and mitigation during product development, technology transfer, commercial operations, and product....

- Harrisburg, PA

WHY YOU MIGHT BE INTERESTED This position will lead all site quality in QA and QC. This company is a well know on the world stage and is growing everyday. You will have 4 direct reports and about 30 indirect. WHAT WILL YOU DO IN THIS ROLEWorking with the global requirements to keep the Quality Management System in line with the local team. Department budgeting, personnel, investment planning for long-term objectivesWill work on all ISO Certifications in regards to cGMP compliance and auditsSet


Pharmaceutical company in need of Director or Senior Director to join the Medical Affairs team. The Medical Director will provide support and expertise in the area of psychiatry either Schizo or Addiction as there are two needs In this newly created and high profile role you will serve as the medical affairs strategic lead for our combination oral schizophrenia treatment that is currently in phase 3 clinical development. The Medical Director is expected to establish key medical strategies for....


The Senior Manager Clinical Operations is responsible for developing operational strategy for one or more clinical studies, and leading the cross functional Study Management Team to align and deliver on study goals of data quality, timelines, budget and GCP compliance in support of overall program level plans. Responsibilities: The Senior Manager Clinical Operations Lead will independently plan all aspects of the clinical operations for one or more clinical studies and oversee the execution of


Position Overview The Director Real World Evidence Analytics ensures that real-world evidence (RWE) studies and queries are strategically designed and optimally executed to the highest standards. This research includes data management, programming, and statistical analysis of health claims, electronic medical records, and other observational data sources. The Director also keeps current with healthcare policies, RWE data trends Biopharmaceutical industry, and other developments with other....

- Greenville, SC

Reporting directly to the Quality Systems and Compliance manager, the Quality Auditor will have responsibility to audit scheduling, planning, execution and documentation of quality system audits of internal processes for the Greenville location. This position will also be responsible for maintaining a library of standards and for reviewing all applicable regulations, standards and communicating requirements to site leadership. This position will provide cGMP / GXP, technical and auditing....


We are looking for a Quality Assurance Document Control Associate to provide assistance with maintaining a GMP documentation system. Roles And ResponsibilitiesAssist in implementing information systems for managing document tracking, controlled document distribution (issuance) and records management.Oversee the issuance and maintenance of logbooks.Facilitate the final review of production batch records.Assist in administering the change control system (issuance, tracking, and....

- Palo Alto, CA

The Director is primarily accountable for nonclinical toxicology, working in collaboration with nonclinical pharmacology and pharmacokinetic scientists to drive the overall global nonclinical regulatory submission strategy and coordination for multiple company portfolio products, from research to registration and beyond. The individual has experience in evaluating and responding to inquiries from regulatory authorities addressing global nonclinical development issues in support of IND and....

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