- Sanofi Group (Swiftwater, PA)
- …in manufacturing systems. Your role will focus on maintaining high performance, regulatory compliance , and operational efficiency in our IMS environment. We ... and other cross-functional teams to ensure alignment with production goals and regulatory requirements. + ** Compliance & Risk Management:** Ensure that all… more
- Merck (West Point, PA)
- …Medical Devices, Packaging Engineering, Packaging Equipment, Packaging Processes, Pharmaceutical Packaging, Process Optimization, Regulatory Requirements, Risk ... packaging process and equipment issues, optimizing processes, and ensuring compliance . Effective collaboration with site-based and above-site based functional teams… more
- University of Pennsylvania (Philadelphia, PA)
- …teams and investigators he/she will prepare, and process all required regulatory documentation for NIH, pharmaceutical companies, contract research organizations ... regulatory staff meetings, research team meetings, and ongoing protocol training/ compliance meetings. The Regulatory Affairs Start-Up Specialist- is expected… more
- Sumitomo Pharma (Harrisburg, PA)
- …HRIS, timekeeping, benefits). + Lead audits, reconciliations, and reporting to maintain compliance with regulatory requirements and internal controls. + Oversee ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and… more
- Merck (West Point, PA)
- …Analytical Technology (PAT), Professional Networking, Project Portfolio Management (PPM), Regulatory Compliance , Regulatory Submissions, Results-Oriented {+ ... developing analytical methods, assay transfer to GxP laboratories, and supporting regulatory filings including INDs/IMPDs and BLAs.- The successful candidate will be… more
- Merck (West Point, PA)
- …stage and commercial drug product processes for vaccines, biologics, and sterile pharmaceutical products. It is the division's leader in sterile product and process ... transfer to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations. The group… more
- Brenntag AG (Reading, PA)
- …documentation, regulatory adherence, and internal audit processes to ensure compliance with industry standards and corporate policies. + Develop and monitor key ... and maintaining QA policies, procedures, and the quality manual to ensure compliance with evolving regulatory and industry standards. + Strong analytical… more
- Sumitomo Pharma (Harrisburg, PA)
- …data through review, cleaning, auditing, validation procedures and ensure data handling compliance with regulatory requirements, especially as it pertains to ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …Establish and maintain data integrity policies, procedures, and guidelines. Ensure compliance with regulatory requirements (eg, FDA, EMA) and industry ... candidate will have a strong background in quality management within the pharmaceutical industry and a proven track record of driving strategic initiatives. **Job… more
- Guthrie (Sayre, PA)
- …in a leadership role. Demonstrated expertise in clinical pharmacy services, regulatory compliance , and quality improvement. Must exercise judgment affecting ... + Participate in multidisciplinary rounds and committees to enhance patient care. + Regulatory Compliance : + Maintain compliance with all federal, state… more