Regulatory Compliance Lead

Job Title: CSV SpecialistKatalyst Healthcares and Life Sciences is seeking a highly skilled CSV Specialist to join our team.Responsibilities:Provide leadership and oversight to project teams in the area of Computer System Validation, ensuring compliance with regulatory requirements.Ensure the quality oversight of GxP regulated computerized systems, including...

Job Title: Quality Compliance LeadLegend Biotech US is seeking a Quality Compliance Lead to join our Quality team based in Raritan, NJ.Job SummaryThe Quality Compliance Lead will be responsible for regulatory compliance supporting the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom...

Job SummaryThe Quality Compliance Lead will be responsible for ensuring regulatory compliance in the production of autologous CAR-T products for clinical trials and commercial operations in a controlled cGMP cleanroom environment. This role will support the implementation, execution, and improvement of the internal audit process, as well as coordinate front...

Key Responsibilities:* Develop and execute validation plans for FDA and Global regulated environments.* Ensure compliance with GxP standards and industry guidelines (e.g., GAMP).* Collaborate with cross-functional teams to design and implement validation strategies.* Create and review documentation for validation deliverables, including requirements,...

Job Title: Associate Director, Regulatory Affairs Labeling Product LeaderJohnson & Johnson Innovative Medicine is seeking an experienced Associate Director, Regulatory Affairs Labeling Product Leader to join our team in Raritan, NJ; Titusville, NJ; Horsham, PA; Toronto, Ontario (CA); UK (High Wycombe); Netherlands (Leiden); Belgium (Beerse); Allschwil, Bern,...

Job Title: Computer System Validation SpecialistOmni Inclusive is seeking a highly experienced Computer System Validation Specialist to join our team. As a Senior Level individual with GxP experience, you will lead our Computer System Validation efforts and ensure compliance with regulatory requirements.Key Responsibilities:Lead Computer System Validation...

Job Summary:Johnson and Johnson MedTech Surgery is seeking a highly skilled Director of Materials Science to support our entire Surgery portfolio of products. This role will be pivotal in building capabilities to accelerate innovation, ensuring product safety and regulatory compliance, guiding cross-functional teams in the integration of materials insights...

Job Title: Metrology SpecialistLegend Biotech US is seeking a highly skilled Metrology Specialist to join our Technical Operations team based in Raritan, NJ.Job Summary:The Metrology Specialist will be responsible for providing technical expertise in support of an effective calibration program that supports daily clinical production and strategically...

Job Title/Role: Senior Technical Leadlocation: Raritan, NJ/remoteMandatory skills: Mulesoft Integration, Healthcare/PharmaMulesoft Developer Skills:Manage and evolve the System Integration platform governance.Manage the System Integration platform and use case demands.Onboard and guide the System Integration use case team (on-demand basis).Participate and...

Johnson and Johnson MedTech Surgery is seeking a Director of Materials Science to support our entire Surgery portfolio of products.This role will work a Flex/Hybrid schedule; there is NO remote option for this role. Relocation assistance is available for qualified candidates.About Johnson & JohnsonWe believe health is everything. Our strength in healthcare...

Job Title: QA Document Control LeadLegend Biotech US is seeking a highly skilled QA Document Control Lead to join our Quality team based in Rarita, NJ.Job Summary:The QA Document Control Lead will be responsible for supporting the document management process within a cell therapy manufacturing facility to meet both clinical and commercial requirements in a...

Job SummaryJohnson and Johnson MedTech Surgery is seeking a Director of Materials Science to support our entire Surgery portfolio of products. This role will work a Flex/Hybrid schedule and is based in Raritan, NJ, with candidates within a commutable distance of Cincinnati, OH also being considered.Key ResponsibilitiesDevelop and implement robust toxicology...

Job Title: Metrology SpecialistLegend Biotech US is seeking a highly skilled Metrology Specialist to join our Technical Operations team based in Raritan, NJ.Job SummaryThis role will be responsible for providing technical expertise in support of an effective calibration program that supports daily clinical production and strategically prepares for commercial...

Job Title: Metrology SpecialistLegend Biotech US is seeking a highly skilled Metrology Specialist to join our Technical Operations team based in Raritan, NJ.Job SummaryThis role will be responsible for providing metrology support for cGMP Clinical and Commercial Cell Therapy Manufacturing. The successful candidate will partner with various Technical...

Job SummaryWe are seeking a highly skilled Cytotechnologist to join our team as a Team Lead in Raritan, NJ. As a Cytotechnologist Team Lead, you will be responsible for overseeing the daily operations of the cytology laboratory, ensuring the highest quality of patient care, and maintaining a fast-paced and customer-focused environment.Key...

SAP SD Lead ConsultantWe are seeking a highly skilled SAP SD Lead Consultant to join our team at Diverse Lynx LLC. As a key member of our team, you will be responsible for leading SAP SD implementation projects and providing expert guidance to our clients.Key Responsibilities:Lead SAP SD implementation projects from start to finishProvide expert guidance to...

Job SummaryWe are seeking a highly skilled Environmental Health and Safety Specialist to join our team at Laboratory Service Inc. As an EHS Specialist, you will play a critical role in ensuring a safe and environmentally responsible work environment and compliance with applicable regulatory requirements and company procedures.Key ResponsibilitiesDevelop,...

Job Summary:We are seeking a highly skilled SAP FICO Lead to join our team at Diverse Lynx LLC. As a key member of our finance team, you will be responsible for leading the implementation and maintenance of SAP FICO systems.Key Responsibilities:Lead the implementation and maintenance of SAP FICO systems, including FI-GL and FI-AP modules.Develop and...

Job Title: Metrology SpecialistLegend Biotech US is seeking a highly skilled Metrology Specialist to join our Technical Operations team based in Raritan, NJ.Job SummaryThis role will be responsible for providing metrology support for cGMP Clinical and Commercial Cell Therapy Manufacturing. The successful candidate will partner with various Technical...

Job SummaryWe are seeking a highly skilled Cytotechnologist to fill the role of Team Lead in our Raritan, NJ laboratory. As a key member of our team, you will be responsible for overseeing the daily operations of the cytology laboratory, ensuring the highest level of quality and accuracy in our testing and reporting.Key ResponsibilitiesAssist with data...