- Daiichi Sankyo, Inc. (Bernards, NJ)
- …updates Study Supply Plans in close communication with CSO project Management Lead .Responsible for the Clinical Label Development process which includes creation ... translations, and label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with… more
- Novo Nordisk Inc. (Durham, NC)
- …SOPs Lead improvement activities/improvement of standards within the assigned process Provide coaching to Site regarding quality & compliance related activities ... controls, review & approval of SOPs, QA presence & process confirmation on shop floor & improvement of Quality...the ability to train on Days. Relationships Manager, Quality Assurance . Essential Functions Ensure plant systems batch release &… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is in a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs), who are responsible for the delivery ... cross-functional meetings or other relevant activities.Support the External Partner Quality Lead (s) (EPQLs), who are responsible for delivering and executing Quality… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Will be a QA presence on the manufacturing floor. Relationships Quality Assurance . Essential Functions Reviews all manufacturing and support records to certify ... compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal audits… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe Quality Director is the senior leader and decision maker for the Quality Department and Quality Management System. This position is ultimately ... in design, validation, and ongoing manufacturing. Ensure strong and efficient process validations to ensure manufacturing success.Drive strong internal audit program… more
- Insmed Incorporated (San Diego, CA)
- …and Best Medium Workplaces™ lists.OverviewThe Senior Director, DSPV Gene Therapy Safety Lead will be the safety expert for Insmed's gene therapy products and ... pre-clinical, clinical trial data, post-marketing, literature) throughout the development process for assigned products and development compounds. Responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary The Non-Regulated Implementation Services Lead is responsible for the strategic oversight, planning, and execution of ... that all non-regulated global corporate systems, regional/global websites, portals, process automation, and related services are developed, implemented, tested, and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe QC Microbiology Group Lead will report directly to Microbiology management, (ie, QC-Microbiology Supervisor) and will provide both laboratory ... and cGLP.Develop and validate new test methods for raw material, in- process , and finished product samples (Sterility, Bioburden and Indicator Organisms, Endotoxin,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Process Excellence is accountable to collect information, analyze quality related process , define strategies to lead to the development and implementation of ... processes and systems organization-wide. Identify and implement best practices for process improvement and standardization. Lead cross-functional teams in the… more
- Merck & Co. (North Wales, PA)
- …with urgency, actively innovate and are supported through continuous learning and feedback process . The chosen candidate should be a leader that strongly ... - The individual in this role will be an independent contributor as well as lead a team and, together, will act as the Business Insight and Analytics partner for… more
- Merck & Co. (North Wales, PA)
- …to anticipate stakeholder requirements.Preferred Experience: Demonstrated success in the assurance of deliverable quality and process compliance. Strong ... deliverables for R&D projects (data, analyses, tables, graphics, listings)A project leader ; completes tasks independently at a project level; ability to collaborate… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Standard Operating Procedures (SOPs) in relation to the batch review/ release process .Contribute to process improvement.Ensure turnaround times are adhered to ... including preparation of documents, presentation to health authorities, and to lead actions in response to potential findings.Ability to utilize multiple electronic… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …project teams and leveraging available resources to deliver assigned project objectives. Lead efforts to analyze "as is" state, make recommendations for improvement ... on a day-to-day basis, and act as the central resource for team communication Lead project scope and deliverables definition in concert with project champion and key… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …development studies, clinical supplies, manufacturing scale up, equipment and process qualification, packaging and labeling. This position will interface with ... Operations, Regulatory, Quality Assurance , Finance, R&D, Project Management and Quality Control departments to complete the technology transfer for customers. This… more
- Genmab (Plainsboro, NJ)
- …will be responsible for owning the end to end Incentive Compensation process from design and implementation to payouts and leadership updates. The Associate ... candidate will have key responsibilities of leading the incentive compensation process for field teams at Genmab.Coordinates with other functions and stakeholders… more
- Tris Pharma (Monmouth Junction, NJ)
- …Test Results for Pharmaceutical ProductionStrong working knowledge of pharmaceutical investigation process and ability to conduct, lead and/or draft effective ... Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team to ensure manufacturing… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …implementing best practices for workplace safety and employee training.Quality Assurance : Maintain high standards of quality in production processes, implementing ... FDA regulations is a plus but not requiredProven experience in process improvement methodologies (eg, Lean, Six Sigma).Exceptional leadership, communication, and… more
- Cytiva (Miami, FL)
- …Filtration - Membrane Sites and leads both the Quality Control and Quality Assurance teams located in Pensacola, Florida. This is an on-site role. At Cytiva, ... & Advocacy: Collaborate with site and global leadership to address process changes, advocate for site-specific needs, and drive customer-centric solutions during… more
- Embraer (Macon, GA)
- …after finishing all designated operations. Submits completed/in-progress work to Maintenance Lead for review; submits to Quality Assurance for final/in-progress ... technical data, and work package instructions. Consults the Maintenance Lead if technical assistance is needed during the repair... if technical assistance is needed during the repair process . Inspects completed work before sign off to identify… more
- Embraer (Nashville, TN)
- …after finishing all designated operations. Submits completed/in-progress work to Maintenance Lead for review; submits to Quality Assurance for final/in-progress ... technical data, and work package instructions. Consults the Maintenance Lead if technical assistance is needed during the repair... if technical assistance is needed during the repair process . Inspects completed work before sign off to identify… more
