- BioAgilytix (Durham, NC)
- …that boost lab productivity and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data ... build quality assurance processes, and monitor data integrity to meet regulatory requirements, including HIPAA, GxP, GDPR, and FIRPA.Design data quality KPIs… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …member of the Technical Operations team, responsible for ensuring adherence to regulatory requirements and internal quality standards across cell and gene therapy ... continuous improvement.The Compliance Auditor will conduct internal audits, support regulatory inspections, and lead investigations to ensure process integrity and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …project portfolio and prioritize and drive projects from inception through regulatory approval to global implementation.Requirements BS required, Ph.D. preferred in ... network and drive change management process from inception through regulatory approval to global site implementation.Candidate must have extensive experience… more
- BioAgilytix (Durham, NC)
- …ISO 27001).Oversee governance, risk, and compliance activities, including policy development, regulatory alignment (GxP/CLIA, GDPR, Part 11), and global data privacy ... vendor and third-party security risk, ensuring adherence to contractual and regulatory obligations.Define guardrails for AI and new technologies, including M365… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various ... talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and other...of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company… more
- Merck & Co. (North Wales, PA)
- …Legal Case Management, Legal Research, Legal Strategies, Negotiation, Pharmaceutical Law , Regulation Enforcement, Regulatory Compliance, Team Play-Preferred ... and support for US litigation matters and data subject requests.Support global regulatory scanning efforts and, with respect to the US, evaluate potential changes… more
- BioAgilytix (Durham, NC)
- …than two (2) years' experience in a scientific laboratory environmentKnowledge of regulatory guidance and industry best practices for LC/MS, and other large molecule ... than four (4) years' experience in a scientific laboratory environmentKnowledge of regulatory guidance and industry best practices for LC/MS, and other large… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in driving consistent statistical approaches and defending them to regulatory authorities is desirableExperience in collaborating with internal technical SMEs ... comparabilityIndustry leading knowledge in technology transfer, process comparability, CMC regulatory guidelines and manufacturing in cell therapyAbility to think… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …that all GMP documents are cutting edge and incorporate all latest regulatory and quality requirements.Track relevant KPIsEnsure periodic review of all GMP documents ... industry.Pharmaceutical GMP's - strong knowledge of Good Manufacturing Practices and regulatory knowledge is a requirementProficient in MS Office applications and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …clean space walkthroughs to ensure GMP compliance.Actively participate in all regulatory and internal audits of the facility.Participate in the hiring, development, ... to ensure quality of work and compliance with all company policies and regulatory guidelines.Help improve metrics performance to drive team results in areas of EHS,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will include but not limited to tasks mentioned above.Support regulatory inspections and audits as needed.Consistently perform tasks in adherence ... requirements, as well as according to state and federal regulatory requirements.Other duties will be assigned, as the need...of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …resulting in the delay of investigation closure and product release.Support regulatory inspections and audits by ensuring inspection readiness within facility and ... serving as an SME during the execution of regulatory inspections and audits as needed.Support compliance activities for...of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in a heavily regulated pharmaceutical environment with adherence to strict regulatory guidelines and internal compliance policies.In depth understanding of cleanroom ... early and mature stages of technology development.Thorough knowledge of regulatory requirements such as 21 CFR Parts 210, 211,...of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and documented in accordance with all cGMP, company policies, and appropriate regulatory standards.Performs work review, approval and close out of work orders, ... (CMMS)Quality Management knowledge, including Change control, Deviation, and CAPA's.EHS and regulatory standards (eg EPA, OSHA and DEA)Candidate to have experience… more
- Merck & Co. (Rahway, NJ)
- …you interested in the intersection of scientific innovation and property law , especially how to efficiently capture innovation with intellectual property, ... of the business including discovery, development, manufacturing and supply, regulatory , business development, commercial groups, and other legal functions.Responsibilities… more
- BioAgilytix (San Diego, CA)
- …in a supervisor role and leading teams Knowledge and application of regulatory guidance to experimental planning and design Experience working in GxP environments ... BioAgilytix's hiring range for this positionBENEFITS AND OTHER PERKSMedical Insurance (HDHP with HSA; PPO), Dental Insurance ,...results of genetic testing, service in the military, or any other group protected by federal, state, or local law… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …any supply disruptions or material quality related issues.Support Quality, Regulatory and Financial audits.Provide timely responses to business units' ... of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company...veteran status, or any other characteristic protected by applicable law .Employment is at-will and may be terminated at any… more
- Legend Biotech USA, Inc. (Detroit, MI)
- …franchise.Fully understand and apply MSL SOP's/guidelines and company HCC/ Regulatory /Legal guidelines.RequirementsAdvanced terminal degree (PharmD, PhD, MD, DO) OR ... of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company...veteran status, or any other characteristic protected by applicable law .Employment is at-will and may be terminated at any… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …any supply disruptions or material quality related issues.Support Quality, Regulatory and Financial audits.Provide timely responses to business units' ... of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company...veteran status, or any other characteristic protected by applicable law .Employment is at-will and may be terminated at any… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …attitude under some supervision.Comfortable with speaking and interacting with regulatory inspectors.This position may require occasional travel to partner sites ... of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company...veteran status, or any other characteristic protected by applicable law .Employment is at-will and may be terminated at any… more
