- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based ... in Raritan, NJ. Role OverviewThe Quality Systems Lead role is an exempt level position with responsibilities for supporting the quality systems … more
- Actalent (Irvine, CA)
- Job Title: Quality Systems Engineer Job Description As a Quality Systems Engineer, you will own and lead the execution of quality plan actions ... of compliance while meeting business needs. Responsibilities Own and lead execution of quality plan actions and...plans and QMS build-out. Proficiency in Windchill and ETQ systems . Strong knowledge in compliance, quality assurance,… more
- Beacon Engineering Resources (Wethersfield, CT)
- Quality Systems Manager Position Overview: We are seeking a Quality Systems Manager to lead the development and oversight of our Quality ... Chain to ensure consistent quality outcomes. Deliver training on quality systems , procedures, and best practices across departments. Required Qualifications:… more
- BridgeBio Pharma (San Francisco, CA)
- …focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM). What You'll Do The Sr. Manager, Quality Systems Management will report to the Vice President of ... responsible for overseeing the development, implementation, and continuous improvement of the quality management systems (QMS) to ensure compliance with GxP… more
- Merck & Co. (Rahway, NJ)
- …products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The director will lead a team of engineers and technical ... proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems .Qualifications:Bachelor's degree in Mechanical Engineering, Biomedical… more
- Aequor (Houston, TX)
- …the most likely cause of the deviation investigation o Familiarity with cGMP quality systems , and demonstrates ability to read and comprehend GMP documents ... cause of the deviation investigation Knowledge Familiarity with cGMP quality systems , and demonstrates ability to read...processes for investigations Willing to pursue opportunities that can lead to substantial benefit, even if there are risks… more
- Aequor (Thousand Oaks, CA)
- …Drug Product Formulation and Vial/Syringe Filling operations Experience with various quality systems including change control, deviations, corrective and ... Lead within the New Product Introduction, Manufacturing Execution Systems , and Digital team at ATO B20. The NPI...value to the network: Manufacturing, Process Development, Supply Chain, Quality , and Facilities & Engineering. A high degree of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …working within an aseptic manufacturing facility, preferably in training/system applications, quality systems , or learning management systems .Knowledge of ... curriculum in areas of general use, foundational and core skills, systems , unit operations and aseptic processingPrepares and maintains training lab, materials… more
- Merck & Co. (Rahway, NJ)
- …Standard Operating Procedures (SOP) and current GXP documents.Experience with quality systems .Excellent organizational skills.Desire and willingness to learn, ... its' Performance Qualification and Process Simulation execution, the selected candidate will lead and contribute to the launch and regulatory certification of the… more
- Repligen (Clifton Park, NY)
- …will play a key role in delivering the site expansion programs, implementing quality management systems and maintaining ISO certification. The individual will ... OverviewThe Operations Leader role for Repligen is a senior position...involved, collaborating with headquarters functions for harmonization for matrixed roles. Lead all operations at the site, including Planning, Procurement,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …help the team, in a manner consistent with safety policies, quality systems , and cGMP requirements.Support manufacturing investigations, create/revise ... a team-based environment, on an assigned production shift schedule.Key Responsibilities Lead and supervise multiple units within the CAR-T process operations (ie… more
- Eisai, Inc (Indianapolis, IN)
- …If this is your profile, we want to hear from you. The Area Business Leader (ABL) will engage with assigned health systems for Eisai's oncology portfolio and ... (S-suite, C-suite, KOLs, Pathway and PandT committee members). Each ABL will lead account responsibility for a defined number of potential strategic accounts and… more
- Merck & Co. (Durham, NC)
- …pharmaceutical manufacturer? If so, then this is the opportunity for you! The Lead Tech, Engineering is a member of the Engineering team providing technical support ... an inclusive team culture including significant interaction with operations, quality , automation, technology, and other groups as required.Key Duties:Ability to… more
- BioAgilytix (Durham, NC)
- …That means hands-on work designing Azure Data Factory and API integrations, automating data- quality checks, and setting up clear governance so everyone knows who can ... keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data governance framework, with hands-on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and ... around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation,… more
- Boston Scientific (St. Paul, MN)
- …and compliance of Legacy Medical Electrical Equipment. This role will serve as quality lead in maintaining the design, development, verification, validation, and ... particularly proven experience with complex, multi-site problem-solving Acts as an effective leader or team member in supporting quality disciplines, decisions,… more
- Generac Power Systems, Inc. (Trenton, SC)
- … Quality Engineering Specialist works with suppliers and personnel to improve quality systems and performance. This position is responsible for ensuring that ... personnel with the establishment of supplier expectations and objectives. Lead the resolution of supplier quality issues.... Metrics. Conduct and manage audits/assessments of processes and quality systems (ISO, internal audit, etc). Gather… more
- Anduril Industries (Costa Mesa, CA)
- …Master's degree in a technical field 5-7 years of experience with developing quality systems for low volume, high complex manufacturing environments and ... Systems Analysis (MSA), Automotive Industry Action Group (AIAG) quality improvement techniques, and Geometric Dimensioning and Tolerancing (GD&T). A strong… more
- Randstad (Georgetown, KY)
- …procedures. Oversee the testing and repair of all incoming and outgoing systems , ensuring functionality and quality before deployment. Develop and refine ... uphold high- quality standards to enhance the overall quality of systems and parts within inventory....3 years Experience level: Experienced Randstad is a world leader in matching great people with great companies. Our… more
- Taco Family of Companies (Cranston, RI)
- …Responsibilities include but are not limited to: Supports development and maintenance of quality systems by writing quality plans, including dimension ... positive mental attitude that helps us to be a leader in the industry A commitment to building strong...a manufacturing environment Proficiency with Enterprise Resource Planning (ERP) systems (Epicor a plus) and quality management… more
