Lead Quality Assurance Cell Therapy & GMP Compliance
Celularity, Inc.
Celularity Inc. is seeking a Lead, Quality Assurance to uphold clinical and commercial product quality through QA review of records, batch documentation, QC data, and donor eligibility records. You will support QMS processes, SOPs, training, and regulatory interactions to ensure Celularity quality standards are met. The role requires deep knowledge of cGMP/GTP, CAPA workflows, investigations, and audits, with a focus on ensuring inspection readiness across product areas and cross-functional #J-18808-Ljbffr
- ...will follow SOPs, work instructions, and batch records under supervision, ensuring quality and regulatory compliance. Role involves cross-functional collaboration, potential Team Lead duties, and training teammates on Source Governing Documents while maintaining ALCOA+...Suggested
- .... is seeking an Associate Director, GCP Quality Assurance to provide senior-level quality oversight... ...development activities, ensuring compliance with ICH, FDA, EMA, PMDA, MHRA and other global requirements. You will lead risk-based audits of investigator sites,...Suggested
- Scorpion Therapeutics is seeking a Manufacturing Team Lead for Liso-cel CAR-T cell therapy production, overseeing GMP manufacturing processes in a controlled cleanroom setting. The role involves a night shift (Wednesday-Saturday) onsite in New Jersey, guiding equipment...SuggestedNight shift
- Novartis in Morris Plains, NJ, seeks a Quality Team Leader QA Compliance to lead a fast-moving team ensuring robust quality systems and patient safety. You will guide QA activities, support regulatory inspections, and drive continuous compliance improvements across the...Suggested
- Role Manufacturing Team Lead for Liso-cel CAR-T cell therapy production, overseeing GMP manufacturing processes in a controlled cleanroom setting. Responsibilities... ...aseptic techniques record production data in compliance with GDPs support continuous improvement initiatives...SuggestedShift workNight shift
$69.67k - $84.43k
...Team Lead overseeing cryopreservation and cell therapy manufacturing operations at a CAR-T facility. Provides tactical leadership to specialists managing... ...material handling, liquid nitrogen systems, and regulatory compliance across multiple shifts in a regulated pharmaceutical...Shift work- ...innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to... ...from discovery to delivery.What you’ll do:Lead the Americas commercial business to achieve... ...biopharmaceutical manufacturing process flow, and GMP. Experience working with large...Hourly payFull timeRemote workWork from homeFlexible hours
$43 - $48 per hour
...dedicated team, ensure clinical excellence, and maintain 100% compliance with NJ regulations while delivering an exceptional patient experience... ...benefits underpin a culture focused on balance, growth, and quality care at our Verona clinic #J-18808-Ljbffr IV NutritionHourly payFlexible hours- ...is seeking a Manufacturing Associate in Summit, NJ to support cell therapy production in a cGMP cleanroom. You will operate equipment, follow... ...aseptic techniques and proper documentation. Onsite shift, safety, and quality are priorities. #J-18808-Ljbffr Bristol Myers SquibbShift workNight shift
- ...Shionogi Inc. in Florham Park, NJ is seeking a Senior Manager, Regulatory Affairs CMC to lead strategic CMC regulatory activities under the guidance of the Senior Director. You will coordinate with R&D, QA, manufacturing, and commercial teams to align regulatory plans...
- ...Affairs, Global Reg Strategy US & Canada. You will develop and implement strategic and tactical plans for US and Canada regulatory compliance, ensuring alignment with the GRPT and business needs. You will interface with FDA, prepare briefing packages, and coordinate...
$114.1k - $211.9k
...role in ensuring the highest standards of quality, compliance, and patient safety across our... ...Quality Team Leader QA Compliance, you will lead a team responsible for maintaining robust... .... At least 5 years of Quality Assurance or Quality Control experience within pharmaceutical...- ...A regional CPA and advisory firm is seeking a Tax Partner to provide sophisticated tax planning and compliance services for real estate clients. The ideal candidate will have at least 10 years of experience, strong leadership and mentoring skills, and a CPA qualification...Full time
$185.5k - $344.5k
...require up to 20% travel.Reporting into the ED, US Business Strategy Lead, this role leads day-to-day strategy engagements within US... ...stakeholder alignment, synthesis, recommendations, and handoff quality.Job DescriptionKey Responsibilities:Lead development of strategic...Full timeLocal areaRemote workRelocation- ...Schindler Group in Morristown, NJ seeks a Senior Paralegal with 4–6 years of paralegal experience to support a broad range of legal, compliance, litigation, and operational matters. You will work closely with attorneys and business stakeholders in a small, high-performing...
$94.26k - $175.06k
...Ferring pioneers and delivers life-changing therapies that help people build families and live... ...shutdowns, ensuring safety, budget compliance, and timeliness. They coordinate planning... ...monitoring maintenance, validation, and quality tasks to address any issues promptly. Additionally...Full timeTemporary workLocal areaFlexible hoursShift work- ...Kite Pharma in the United States seeks a Director, Submission Project Management to lead strategic and operational planning for major regulatory submissions (BLAs, sBLAs, NDAs) across Clinical Development, Regulatory Affairs, Data Management, and Biostatistics. The role...
- ...prohibited by the laws that govern its operations. Senior Manager, Quality Assurance and Compliance | North America Claims, Claims Shared Services- AXIS is... ...and Compliance, Claims Shared Services, this role will lead, oversee, enhance and optimize the North America claim...Work at office
- Shionogi Inc. (U.S.) is seeking a GVP/GCP QA lead to support and maintain a global PV quality program, collaborating with Global QA teams to ensure regulatory compliance with FDA, EMA, MHRA, PMDA and ICH, including PV systems and PSMF. The role develops, implements, and...
$120k - $145k
A pharmaceutical company in New Jersey is seeking a Quality Assurance Manager to oversee cGMP compliance for contract manufacturers and manage quality systems. Ideal candidates should have a Bachelor's degree in a technical field, at least 10 years of experience in the...Contract workFlexible hours- ...device company, seeks a Senior Legal Counsel, Global Privacy, to lead the worldwide privacy program and advise on privacy, data... ...Parsippany, NJ partners with stakeholders to ensure regulatory compliance while enabling growth. 5+ years' privacy-focused legal experience...Worldwide
- ...'s Health in New Jersey seeks a Lab Director to oversee the clinical laboratory and multiple departments. You will ensure policy compliance, drive standardization, and engage with Corporate Laboratory Operations Leadership on instrumentation and LIS. The role requires...Full timeDay shift
- ...Sanofi is seeking a Medical Director, Pulmonary, to lead the US medical/scientific strategy for Pulmonary products within Immunology Medical Affairs. You will partner with Clinical, Commercial, Regulatory and Market Access to drive evidence generation and medical engagement...
- AXIS Capital is seeking a Senior Manager for Quality Assurance and Compliance in North America Claims. The role leads audit programs, oversees TPA oversight, and drives QA improvements across complex claim operations. Responsibilities include analytics, reporting, and...Work at office
- ...care, and personalized therapy.?At Children’s... ...solutions that enhance quality of life for all children... ...serve. Join Us as a Lead BCBA in our Social Connections... ...development, quality assurance, and implementation... ...families, addressing compliance issues and complex clinical...Hourly payTemporary workTraineeshipLocal areaMonday to Friday
$49.34 - $60.23 per hour
...Respiratory Therapist Lead Req #: 0000266898 Category: Respiratory... ...observe procedures in various units and assure the new employee's understanding. Completes... ...etc. Utilizes principles of continuous quality improvement in all work situations to assess...Hourly payFull timeTemporary workFlexible hoursShift workNight shift$185.5k - $344.5k
...up to 20% travel. Reporting into the ED, US Business Strategy Lead, this role leads day-to-day strategy engagements within US... ...stakeholder alignment, synthesis, recommendations, and handoff quality. About the Role Key Responsibilities: ~ Lead development...Full timeLocal areaRemote workRelocation- ...investigational and marketed products. You will prepare, review, and finalize Health Authority submissions and responses, ensuring compliance with local requirements. You will provide high-level expertise, oversee document control, and mentor teams while monitoring...Local area
- ...Schindler Elevator Corporation in Morristown, NJ is seeking a Customs & Trade Compliance Manager. This hybrid leadership role builds the global compliance framework and standardizes processes across regions, reporting to Finance. You will oversee customs brokers, manage...
- ...Head of Global Ethics and Business Integrity Principles, Learning and Communications to advance the EBI program worldwide. This role leads the Code of Conduct evolution, global learning programs, and communications that align with Sanofi’s standards and regulatory...Worldwide
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