BioPharma Consulting JAD Group

πŸ‘₯ 51-100TherapeuticsConsultingπŸ’Ό Private Company
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BioPharma Consulting JAD Group is a consulting firm specializing in validation, engineering, and compliance solutions for the biotechnology and pharmaceutical industries. We help our clients navigate the complexities of regulatory compliance, ensuring the quality and safety of their products. Our expertise spans the entire product lifecycle, from development to manufacturing and beyond. We differentiate ourselves through a deep understanding of GxP regulations, a commitment to process excellence, and a collaborative, client-focused approach. Our team leverages a robust technology stack including Google Analytics, WordPress, Microsoft Exchange Online, Microsoft Azure DNS, and ASP.NET, ensuring efficient and secure operations. We foster a collaborative and supportive environment, valuing continuous learning and professional development. Our fully remote work model allows us to attract top talent from across the United States and promotes work-life balance. We are a growing company with 51-100 employees established in 2010, headquartered in Cambridge, Massachusetts. Our commitment to quality and compliance is reflected in our strong client relationships and our success in helping companies achieve their regulatory goals. We provide comprehensive support for critical quality processes, including deviations, CAPA, change control, regulatory intelligence, and training. BioPharma Consulting JAD Group offers a rewarding career path for individuals passionate about advancing quality standards within the biopharmaceutical sector. We prioritize a positive work environment and offer competitive benefits to support our employees' growth and well-being. Our team’s diverse backgrounds and experiences enhance our ability to serve a global client base.

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πŸ“ United States

🧭 Full-Time

πŸ” Biotechnology or pharmaceutical

  • Bachelor's degree in Life Sciences, Engineering, or a related field.
  • 2+ years of experience in Quality Systems within biotechnology or pharmaceutical industries.
  • 1+ years of experience in manufacturing, operations, or related business areas.
  • Demonstrated experience in process ownership and quality systems management.
  • Strong understanding of GMP, GLP, GCP regulations, and ICH guidelines.
  • Experience with electronic quality management systems, specifically Veeva.
  • Serve as global process support for Deviation, CAPA, Change Control, Regulatory Intelligence, and Training processes.
  • Facilitate analysis of Quality Systems metrics and performance periodically.
  • Manage Quality Systems deviations and CAPAs, ensuring proper investigation, resolution, and preventive measures.
  • Oversee Regulatory Intelligence assessments and maintain associated documentation.
  • Facilitate the Change Control Review Board and maintain associated documentation.
  • Partner with subject matter experts to identify GxP training content needs and modify curricula.
  • Support development of Quality related training content.
  • Support quality systems audits and regulatory inspections.
  • Provide guidance and support to site quality teams in process implementation.

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