- Highmark Health (Harrisburg, PA)
- …team of specialists. Identify, develop, coordinate, and implement legislative, regulatory , sub- regulatory , and licensing / accreditation requirements.Perform ... ongoing monitoring and analysis of external regulatory and industry intelligence, collaborating with impacted stakeholders, and providing regular, executive… more
- Merck (West Point, PA)
- …with batch disposition (release) activities. + Background in quality control, quality assurance , auditing or regulatory affairs. + Effectiveness and creativity ... compliance with current Good Manufacturing Practices (cGMPs) regulations and relevant regulatory filing submissions. Areas of focus of this position revolve around… more
- Charles River Laboratories (Malvern, PA)
- …sites. ⦁ Serve as consultant to all company divisions on related quality and regulatory issues. ⦁ Provide regulatory guidance to internal departments for ... the importance of quality/compliance within the organization. Work directly with senior corporate operations management teams to ensure regulatory compliance… more
- Catalent Pharma Solutions (Philadelphia, PA)
- ** Senior Quality Assurance Document Control** **Position Summary** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) ... for patients annually. Catalent Pharma Solutions is hiring a Senior Quality Assurance Document Control. The ...Quality Operations department supports this by providing oversight and guidance on matters affecting the quality system or product… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …the health authority. - Represents GRA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- The Hershey Company (Hershey, PA)
- Job Location: Hershey, PA * Summary:* Under Minimal guidance , the Quality Assurance Specialist's primary role is to serve as a liaison between Quality ... quality system requirements. Some laboratory duties are required. In addition, the Senior Quality Assurance Specialist: * * Compliance:* Facilitates production… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …at Olympus (https://www.olympusamerica.com/careers) . **Job Description** The Clinical Quality Assurance Manager reports directly to the Executive Director of ... Clinical Quality Assurance and provides support to ensure the quality and...compliance with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards. + Lead… more
- Commonwealth of Pennsylvania (PA)
- …facts, and accuracy of the materials in accordance with engineering standards and regulatory guidance documents. + B. I have professional experience assisting ... Senior Civil Engineer (General) Print (https://www.governmentjobs.com/careers/pabureau/jobs/newprint/4908432) Apply Senior Civil Engineer (General) Salary… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …position reports to the Quality Assurance Manager and provides Quality Assurance guidance and support for activities related to Manufacturing and Packaging ... ** Senior Engineer, Quality Operations** **Position Summary** Catalent, Inc....operations at Catalent Philadelphia. Supports regulatory compliance with FDA cGMPs, DEA requirements, Clinical Supply… more
- ICON Clinical Research (Blue Bell, PA)
- Senior CRA/ CRA II (Midwest and West) ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive ... mission to shape the future of clinical development. We are currently seeking a Senior Clinical Research Associate (CRA) or CRA II to join our diverse and dynamic… more
- Lumen (Harrisburg, PA)
- …manager to bolster and drive our compliance programs. Reporting to the Senior Director Security for GRC and Business Enablement, the information Security Governance ... our external and internal obligations. This role will be expected to provide guidance and make determinations relevant on controls that govern the steps, methods, or… more
- Prime Therapeutics (Harrisburg, PA)
- …It fuels our passion and drives every decision we make. **Job Posting Title** Senior Internal Auditor - Remote **Job Description** The Senior Internal Auditor ... fostering strong cross-functional relationships and delivering risk-based insights, the Senior Internal Auditor helps drive informed decision-making and support… more
- Grant Thornton (Philadelphia, PA)
- Grant Thornton is seeking a Senior Director of Compliance to join the team. Approved office locations can be found below. + This role will focus on developing, ... to sanctions, AML, anti-bribery and conflicts of interest as well as other regulatory areas relevant to professional services firms. + In addition to laying the… more
- Edwards Lifesciences (Harrisburg, PA)
- …with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize ... and be part of our inspiring journey. As the ** Senior Specialist, Commercial Clinical Imaging** , you will be...and other imaging modality acquisition and interpretation and provide guidance on case planning strategy execution. + Responsible for… more
- Deloitte (Pittsburgh, PA)
- …with a well-respected team of proven innovators! Work you'll do: As a Senior , you will identify eligible federal C&I generating activities and manage and facilitate ... member firms - Tax, Advisory, Consulting, and Audit and Assurance . The ideal candidate is invested in the team's...process improvements and opportunities for new services. The Tax Senior will ensure accurate, timely completion of deliverables. The… more
- Cardinal Health (Harrisburg, PA)
- …on those requirements. + Uphold quality standards that adhere to company, regulatory , and HIPAA policies and procedures. + Collaborate across various functions, ... skills with a proven ability to develop and execute effective quality assurance programs. + Works independently within established procedures; may receive general … more
- Merck (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. The incumbant is responsible for… more
- Legrand NA (Canonsburg, PA)
- …to the quality policies, standards, and systems necessary for quality assurance and supplier quality efforts to ensure customer satisfaction, regulatory ... business. What Will You Do? + Develop and implement a global quality assurance strategy aligned with company objectives set to aid and improve business performance… more
- Bausch + Lomb (Harrisburg, PA)
- …B&L departments (eg, R&D/Project Management, Clinical/Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance , Pharmacovigilance/GPSS and Drug/Device ... completion of clinical studies according to applicable regulations and guidance , ICH and GCP, and Bausch & Lomb SOPs...are being met and provide the operations director and/or senior management with timely updates on progress and changes… more
- Guthrie (Sayre, PA)
- …research protocol involving human subjects can commence. + Advises The Guthrie Clinic senior leadership on HRPP regulatory issues. + Oversee FDA inspections, ... pairs the Executive Director of Research (physician leader-HPA) with a senior administrative executive to collaboratively lead the strategic, operational, and… more