- Legend Biotech USA, Inc. (Raritan, NJ)
- …scale cGMP manufacturing, operations management, tech transfer, process and equipment validation or quality management; with a preference for Cell/Gene ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan,… more
- Insmed Incorporated (San Diego, CA)
- …process development support testing function within analytical development. Will develop systems and processes to facilitate rapid, high throughput testing. As the ... on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take care of the… more
- Twist BioScience (South San Francisco, CA)
- …MES professionals, primarily software developers, who work in concert with Manufacturing Operations, Quality Assurance, and R&D. The Director will serve as the ... Sr. Director , Manufacturing Execution System (MES) (Hybrid in South...and data visualization capabilities to support operational decision-making and quality reviews.Compliance & Validation : Ensure our custom… more
- Eisai, Inc (Nutley, NJ)
- …out routine, complex and for-cause audits Knowledge of data integrity controls and systems quality for clinical area Strong analytical skills and report writing ... is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director...skills Experience with GxP systems including computer system validation and associated… more
- Merck & Co. (Rahway, NJ)
- …testing, and process validation , with a strong understanding of quality management systems and regulatory compliance.Exceptional project management skills ... products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The director will lead a team of engineers and technical… more
- Eisai, Inc (Exton, PA)
- … Director writes, reviews, and/or approves GMP documents, including validation protocols and reports, and SOPs, along with providing supporting documentation. ... Interact cross-functionally with Support Services, Facilities, Biologics Process Development, Quality Assurance, Quality Control, Validation , and… more
- Merck & Co. (San Francisco, CA)
- Job Description Position Description: Associate Director , DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS) ... interdependent across our functional areas, Discovery, our Manufacturing Division Quality , and BARDS, to name a few, and with...of the DSCS Digital Program Mgmt Lead, the Associate Director , DSCS Digital Project Manager, will be responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Implementation Services Lead plays a key role in overseeing the development, validation , implementation, and integration of GxP-regulated systems across the ... organization. This position ensures that all global systems , electronic records, validation processes, and regulated...4+ years of proven leadership experience managing technical and validation teams, preferably at Director or Senior… more
- Catalent Pharma Solutions (Harmans, MD)
- …Analysis, and validation impact evaluations. + Oversee computerized maintenance management systems (CMMS) and electronic quality systems for asset ... **Associate Director , Validation & Engineering** Catalent Pharma...validation policies and strategies that align with Catalent's quality standards, FDA/EMA requirements, and industry best practices. This… more
- Gilead Sciences, Inc. (La Verne, CA)
- …standardization and harmonization of Standard Operating Procedures, leveraging existing Gilead Quality Systems . **Basic Qualifications:** + Bachelor's degree in ... complex sterile product qualification activities. + Expertise in contamination control, cleaning validation and isolator systems . + Adopt best practices for… more
- Curia (Rensselaer, NY)
- …a cGMP regulated industry specific to computer systems validation + Validation experience in a cGMP quality control laboratory or sterile fill finish ... role is responsible for supporting Quality Management Systems and Computer System Validation efforts. Additionally,...Other duties as assigned by QA manager and/or QA director Education and Experience: + Bachelor's degree in Engineering,… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who we are?...more than 280 employees. Your role Reporting to the Quality Director , JOB SUMMARY: This is a ... and recertification of sterile processes. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: Computer Systems Validation Activities (50%) Reviews and aids in developing… more
- Bristol Myers Squibb (Indianapolis, IN)
- …to be the global leader in radiopharmaceuticals. The Sr. Manager, IT - GxP Computer Systems Validation & IT Process Lead is an integral part of bringing ... commercialization goals. **Job Responsibilities** + Manage and Deliver applicable risk-based Computer Systems Validation across RayzeBio Digital and IT teams. +… more
- Stantec (Rochester, NY)
- …stored in GMP conditions and distributed, including computerized and automated systems which require qualification and validation for compliance. The ... commissioning and validation of equipment, facilities, utility systems and computerized systems are intended to verify that they are designed, installed,… more
- PCI Pharma Services (Rockford, IL)
- …Validation Engineer - Medical Device Assembly (CDMO)** **Location:** [Rockford] **Department:** Quality **Reports To:** Director of Quality **Position ... welding, and other medical device assembly technologies. + Familiarity with software validation and PLC-based control systems . + Six Sigma certification or… more
- Actalent (Elwood, KS)
- …to define user requirements and establish an appropriate CQV strategy. + Support quality systems such as change control, deviations, CAPA, audits, quality ... consulting with site technical services for process and cleaning validation , while reporting to the Director of...and cleaning validation , while reporting to the Director of Manufacturing Engineering. Responsibilities + Lead all … more
- Abeona (Cleveland, OH)
- … (eg, LIMS, ELN) . Clinical trial management systems (eg, CTMS, EDC) . Quality systems (eg, QMS, Document Management Systems ) . Manufacturing systems ... Job Description JOB TITLE: Computer System Validation Engineer Department: Validation Reports to: Director of Validation As a Computer System … more
- Mount Sinai Health System (New York, NY)
- … and compliance with regulatory requirements. The CRM works in conjunction with the Associate Director and Director of DRG Validation to help develop coding ... methodology. ? Good working knowledge of electronic health records, registration and data systems . Non-Bargaining Unit, 618 - HSO Drg Validation - MSH, Mount… more
- ThermoFisher Scientific (Indianapolis, IN)
- …you make an impact:** Reporting directly to the Vice President, Quality , the Director , Quality - Digital Systems Compliance is responsible for ensuring ... quality system, partnering with IT, Operations and Quality teams to establish robust validation , electronic...team of Quality professionals committed to computer systems compliance and validation of critical business… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- QA Director - Site Investigations & Quality systems Department: Quality Plant Head Location: Monroe, NC START YOUR APPLICATION ... with respect to investigation related observations. Serve as site representative for Quality Systems during regulatory inspections and corporate audits + To… more
