- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to coordinate SOP Training and effectiveness beyond Read and Apply training in LMS. Inspection Readiness Provide support for audits, inspections and inspection ... Director , Development SOP Management Join a Legacy of...systems preferredExperience with requirements related to global health authority inspections , participation in inspection activities and finding… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …are in compliant and prepared for regulatory submissions and / or inspections Ensures that appropriate systems, processes are in place to enhance GLP/GCLP ... with key partners and collaborators.Review, define, develop SOPs, instructions, manuals, inspection readiness strategy for GLP/ research unit for global activities… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro Delaware seeks to add an Attending Veterinarian in the role of Associate ... Director .This position will have overall responsibility for oversight and...Federal regulatory agencies. Leadership for internal and external regulatory inspections (USDA, DEA, DNREC, etc.) of animal facilities and… more
- Merck & Co. (Rahway, NJ)
- …Molecule Analytical Research and Development (SMAR&D) group has an exciting opportunity for a Director role as GxP Strategic Lead based in Rahway, NJ. Join us and ... rigor. Proactively identifying and escalating operational risks. Partnering with director -level management to develop and execute operational and enterprise… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and due diligence activities for assigned product(s), as neededActs as audit/ inspection Subject Matter Expert (SME) for safety surveillance and risk management ... for assigned product(s), through inspection readiness preparation, and may serve as the primary or back-up SME, and may collaborate with team on CAPAs, including… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(liaison with PhRMA, USP, ICH, due diligence, regulatory authority inspections ). Additionally, this position has direct interaction with research laboratory ... members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some complexity. This position makes decisions with consultation. Responsibilities:Planning for Development :… more
- Merck & Co. (North Wales, PA)
- …preparing for numerous potential launches of our medicines and vaccines. As Associate Director , Launch Excellence, you'll play an important role in preparing for and ... to launch readiness across all strategic go-to-market launch components.Drive transparency, inspection and adaptation of launch plan progress - ensuring tactical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... EMA, and PMDA interactions, such as pre-submissions, end of phase 1/2, and inspections - May support the GCL, if applicable, in planning and executing the overall… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This position may require ... and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis and ensure actions are taken (at the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director of GMP Compliance will be a part of the Compliance Support and Remediation team within our company's Global Quality Compliance Support ... ingredients, biologics, vaccines, and devicessupport remediation activities and pre-approval inspection readiness activitiesprovide expert guidance and assistance to our… more
- Merck & Co. (Durham, NC)
- …Durham site.-- The successful candidate will report to the Associate Director , Laboratory Operations to lead start-up new laboratories for microbiological testing ... meet established delivery timelinesProvide active support during audits and inspections (regulatory, internal, safety)Assist regulatory groups by providing documentation… more
- Merck & Co. (Rahway, NJ)
- …of regulatory submissions. -Under the general scientific and administrative direction of Director in the CCFS group and working in conjunction with internal and ... principles. Experience supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA, EMA, JNDA, TGA).-Current Employees apply… more
- County of San Diego (San Diego, CA)
- …monitoring and tracking for assigned programs. Provides budget briefings to the Director . * Oversees survey support services for DPW Capital Improvement Projects and ... DPW's Land Development Division, which also includes Private Development Construction Inspection , Watershed Protection, Flood Control, and Solid Waste Planning &… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- We are currently looking to fill a Director of GMP Compliance & Inspections position. This position will work with cross-functional teams to drive activities ... on compliance awareness and ensure we are performing with in compliance. The Director will also provide support during regulatory inspections and internal audits… more
- BeiGene (San Mateo, CA)
- **General Description:** The Director , GCP Inspection Management, is responsible for: + Supervising activities related to inspection readiness, hosting and ... + Act as R&D Quality Delegate for the Executive Director , R&D Quality, as needed + Support development of...the GCP Inspection Management Team for other inspection types (eg GLP/GLP and PV inspections )… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …including but not limited to, establishing standards and processes for defining inspection readiness, the preparation and conduct of inspections , the integration ... training of Gilead R&D personnel on dossier collation and requirements pre-regulatory agency inspections , in partnership with the Inspection Lead. + Prepares and… more
- MTA (Brooklyn, NY)
- Director , Ultra Rail Flaw Inspection Job ID: 9141 Business Unit: New York City Transit Location: Brooklyn, NY, United States Regular/Temporary: Regular ... Date Posted: Nov 5, 2024 Description Job Information Title: Director , Ultra Rail Flaw Inspection First Date...be responsible for managing NYCT's internal rail flaw track inspection operations, including UT Inspections and other… more
- Transportation Security Administration (New Orleans, LA)
- …movement for people and commerce. Responsibilities This Assistant Federal Security Director - Inspections position is located in Louis Armstrong International ... to: Planning, developing, implementing, administering and evaluating critical transportation inspections programs for the compliance of persons and transportation… more
- MTA (New York, NY)
- Senior Director Project Management - Bridge Inspection Job ID: 9320 Business Unit: MTA Construction & Development Location: New York, NY, United States ... apply 30 days after their effective date of hire. JOB TITLE: Senior Director , Project Management - Bridge Inspection AGENCY: Construction & Development DEPT/DIV:… more
- City of New York (New York, NY)
- Job Description Under the direction of the Director , Forensic Engineering, the Deputy Director shall perform difficult, responsible, detail-oriented work in the ... related to the following responsibilities: - Manage and supervise the Proactive Inspection team technical staff and Supervising Inspector. - Manage the Predictive… more
