- Globus Medical, Inc. (Audubon, PA)
- …, and Sterile Manufacturing Quality . This position ensures compliance with applicable regulatory requirements ( FDA QSR, ISO 13485, EU MDR, MDSAP, etc.) and ... will collaborate cross-functionally with Manufacturing, Supply Chain, R&D, and Regulatory teams to maintain a culture of quality...is needed within Medical Device Quality Assurance/ Quality Systems with experience in FDA and… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …Chain, Product Development, and Warehousing & Distribution teams to ensure robust quality oversight and regulatory compliance in the handling, storage, ... in compliance with Current Good Manufacturing Practices (CGMP) regulations, Otsuka Quality Standards and US/global (if applicable) regulatory requirements. **Key… more
- West Pharmaceutical Services (Williamsport, PA)
- …+ Directs and manages quality control, quality assurance, quality systems, metrology and/or regulatory affairs, personnel, department resources, and ... Senior Quality Manager Requisition ID: 71560 Date: Nov 26,...to the manufacture of West products. Ensure compliance with regulatory requirements and West procedures. Proactively develop, lead, and… more
- Datavant (Harrisburg, PA)
- …and traceability across all quality activities, systems, and changes in compliance with FDA 21 CFR Part 11 and ICH E6(R3). + Represent Datavant's quality ... Need to Succeed** + 8+ years of experience in quality , compliance, or regulatory roles within life...Strong working knowledge of relevant regulations and frameworks, including ** FDA 21 CFR Part 11, GAMP 5, ISO 9001,… more
- The Hershey Company (Hershey, PA)
- …QA programs and undertakes assignments of very high complexity. Serves as Quality Regulatory Compliance (QRC) representative for multiple Hershey Company ... system requirements. Examples include auditing and assessing internal and external quality programs; interaction with regulatory officials on behalf of Hershey;… more
- Merck (West Point, PA)
- …+ Knowledge of international GMPs and Quality Management requirements of various regulatory agencies (eg US FDA , EMEA, TGA, PMDA, etc.) as well as ... of work across Quality and above site groups. Responsibilities contain Quality , regulatory , and business elements. **The incumbent will be responsible for:**… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …within the pharmaceutical, biotech, or CRO industry. + In-depth knowledge of ICH-GCP, FDA , EMA, and other global regulatory requirements related to clinical ... The **Global Quality Audit Manager** is responsible for planning, executing,...data and ensuring patient safety by verifying adherence to regulatory requirements and internal standards. As a key member… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide ... global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality...requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience… more
- ThermoFisher Scientific (Pittsburgh, PA)
- … Regulatory Affairs, Finance, and Supply Chain. * Perform quality operations processes for the portfolio, including handling customer complaints, medical ... (CCG); RSD NA / HMD; Pittsburgh, PA **Discover Impactful Work:** As a Supplier Quality Operations Specialist, you'll ensure SKU accuracy and product quality by… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …**Compliance & Governance** + Ensure quality operations comply with global regulatory requirements (eg, FDA , EMA, PMDA) and internal standards. + Support ... Veeva, TrackWise). + Familiarity with digital transformation and data analytics in quality operations. + Prior involvement in regulatory inspections and audit… more