- Merck & Co. (Rahway, NJ)
- …and sample testing) in line with the established quality standards and timelines.Collaborate with the audit team in the writing of audit summaries of issues ... Job DescriptionOur company's Audit and Assurance Services primary purpose is to...our company.On occasion, the incumbent will be expected to lead small teams of auditors audits with limited management… more
- Aequor (Tampa, FL)
- 100% on-site The Site IT lead is responsible for effective collaboration between IT and the business functions at the locations under his assignment. Ensure ... key contact & escalation point towards site business leadership team for any IT related matters. The Site IT... for any IT related matters. The Site IT lead is responsible for effective collaboration between IT and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …seeking Manufacturing Lead Operator as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position is responsible for performing ... (1:00pm - 12:30am/1:00am)Key Responsibilities Be part of the manufacturing operations team responsible for production of autologous CAR-T products for clinical and… more
- vaco (Addison, TX)
- …risk-based internal audit plan.Build and manage the Internal Audit team , including recruitment, training, and development of staff. Lead the company's SOX ... Audit ManagerDallas, TX - hybridVaco is working on... Manager to assist in the build-out of an audit team after a recent spinoff. Will...assist in the build-out of an audit team after a recent spinoff. Will be instrumental in… more
- vaco (Atlanta, GA)
- …ResponsibilitiesManage and lead in the development of the operational audit team .Support continuous improvement activities related to overall internal ... Our large, publicly traded client is seeking a Manager of Operational Audit to join their team . They are looking for someone to help shape and grow their… more
- vaco (South Windsor, CT)
- … activitiesIdentify and assess risks; develop mitigation strategiesLead and mentor the audit team , ensuring high performanceEnsure timely completion of audits ... We are working with a regional CPA firm seeking an Audit Senior to lead and enhance their auditing operations, ensuring the accuracy and compliance of their… more
- vaco (Dunedin, FL)
- …client is seeking a detail-oriented and proactive Internal Auditor to join our team in Tampa, Florida. This role will be instrumental in strengthening our internal ... with regulatory standards, including Sarbanes-Oxley (SOX). The Internal Auditor will lead and execute financial, operational, and compliance audits, assess risk, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Continuous Improvement: Lead effective communication efforts within the Medical Affairs team , ensuring collaboration with other GxP QA functions (eg, GMP/IMP QA, ... local inspections by providing adequate systems and process support, ensuring seamless execution. Lead lessons learned efforts based on audit findings, inspection… more
- Aequor (South San Francisco, CA)
- …experienced and strategic Senior Taxonomist to support our Content Review and Management team . This is a 6-month contract role with the possibility of extension up ... reuse, search and discovery, lifecycle management, performance tracking, and audit readiness. You will work cross-functionally with content strategists, regulatory… more
- Merck & Co. (Lower Gwynedd, PA)
- Job DescriptionThe PDMB Regulated Bioanalytics Department is seeking a Director to lead the Compliance team within the Late Development (AdVAnce) Vaccines ... Park facility in Lower Gwynedd Township, PA.-The successful Compliance Director candidate will lead a team that focuses on the development, oversight, and… more
- Merck & Co. (Lower Gwynedd, PA)
- …at least 4 years, or Ph.D. with hands-on experience in related field -Responsibilities- Lead technical writing efforts for the compliance team that involve ... Department is seeking a Compliane Senior Specialist and Technical Writer team within the Late Development (AdVAnce) Vaccines bioanalytical group located at… more
- Eisai, Inc (Nutley, NJ)
- …and execution of the global Clinical Quality Assurance (CQA) strategy including audit and inspection management, issue management and oversight of the Quality ... Clinical Quality Assurance (CQA) strategy for the country/region in scope (including audit and inspection management, issue management, and oversight of the quality… more
- Genscript USA Inc. (Piscataway, NJ)
- …Manager Overview: The role is responsible for leading the direct procurement team , managing end-to-end sourcing and procurement of direct materials and consumables ... supply continuity, compliance with quality and regulatory standards, and readiness for audit requirements. The estimated salary range is $80,000 - $100,000, based on… more
- Merck & Co. (Durham, NC)
- …Director, Electrical & Utilities Engineer is a member of the Plant Engineering team providing direct hands on technical support to the Durham Site.- The site ... and schedules project/work meeting the criteria established by site objectives.Support & lead Utility equipment related projects, scope including but not limited to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …site personnel as neededStudy-specific subject matter expert (ME) for internal audit or Health Authority (HA) questions related to medical monitoringFor studies ... when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionIn partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM is accountable for the execution of operational quality ... The CQOM will facilitate and oversee the responses to audit and inspection observations as appropriate.- In addition, the...levels of knowledge and skill in order to effectively lead and support GCP inspections, worldwide.- Under the guidance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the incumbent may be expected to serve as Program level Delivery Lead on large and/or complex programs, including those involving co-development (Alliance) partners. ... The Early Development (ED) Asset Lead will provide operational expertise for early oncology studies including FIH trials and will possess the scientific knowledge to… more
- Insmed Incorporated (San Diego, CA)
- …leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical development team , and collaborates on ... a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who...inspections and vendor audits.Ability to ensure that a strategic audit plan is developed, designed and implemented, and that… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …seeking Director of Manufacturing Execution System as part of the Global MSAT team based in Raritan, NJ. Role OverviewThe Director of Manufacturing Execution System ... (MES) will be part of Manufacturing Science and Technology (MSAT) Leadership Team and will be responsible for the development of a best-in-class MES organization at… more
- Twist BioScience (South San Francisco, CA)
- …You'll be DoingResponsible for the management of an assigned Twist facility.Hire, lead , coach, performance manage, develop and discipline members of the Facilities ... team , including Supervisors and Sr Supervisors.Primary point of contact...as necessary. Manage vendor services at local facility and inspect/ audit facility for cleanliness and proper 5S efforts. Work… more
