- Merck & Co. (Durham, NC)
- …Inspection Management programs based on new regulations, guidance documents, and industry standards Lead company and site preparation activities for support of ... Job DescriptionThe Quality Associate Director/GMP Lead Site Auditor...Sciences, cGMP Training, Customer-Focused, Detail-Oriented, Driving Continuous Improvement, Ethical Standards , GMP Compliance , Immunochemistry, Internal Auditing, IS… more
- Merck & Co. (Rahway, NJ)
- …review of process questions and issues related to submission content management, quality and standards complianceEngage across functional areas to identify ... ONSITE 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including 3rd party vendors to achieve study milestones and deliverables according to agreed quality standards and timelines and that quality of data is ... implementation in the clinical and regulatory environment across participating regions, provide quality data and ensure timely study delivery- Lead the CRO and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …inspections and audits as needed.Support compliance activities for site Quality Operations in accordance with Legend standards , procedures and ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ.… more
- Christus Health (Taft, TX)
- …of standards and associated clinical procedures Analyzes policy and standards documentation and ensures organizational compliance Provides feedback for ... needs. Documenting daily staffing, operational, and administrative records; maintaining compliance with governmental policies and procedures. Providing direction and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... continuous improvement in collaboration with other QA functions and/or applicable stakeholders. Support/ lead and or co lead due- diligence assessments of GMP… more
- Christus Health (San Antonio, TX)
- …audits to enhance the effectiveness of lactation support services. Ensure compliance with regulatory requirements, patient safety standards , and accreditation ... Santa Rosa Family Health Center. Summary: The Registered Nurse Lactation Consultant Lead is responsible for overseeing and providing expert lactation support and… more
- Insmed Incorporated (NJ)
- … Quality Management System to ensure alignment with regulatory and internal quality standards .Work closely with Quality Assurance, Regulatory Affairs, ... such as Deviations, Change Controls and CAPAs.Ensure all documents meet established standards for accuracy, consistency, compliance , and formatting, while also… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …complaint product supply.Key Responsibilities Support compliance activities for site Quality Operations in accordance with Legend standards , procedures and ... quality indicating data and identifying trends.Provide oversight for trending of quality compliance metrics.Job duties performed routinely require exposure to… more
- Merck & Co. (Rahway, NJ)
- …medical device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- ... products and processes are developed in accordance with applicable regulatory, quality , company, and customer requirements.-This position will lead … more
