- 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
- Merck & Co. (Durham, NC)
- …" Quality Always" environment with participation in Site GEMBAs for Safety and Quality Compliance . Escalate and collaborate quality and compliance ... Quality Assurance Organization, will independently manage Shop Floor Quality Assurance team on second shift. Lead ...cGMP document review and approval. Strong background in cGMP compliance standards (QMS, EHS, and Site SOPs)… more
- Merck & Co. (Rahway, NJ)
- …implementing risk control measures, and performing overall device risk evaluations in compliance with ISO 14971 and other relevant standards . Ensure alignment ... relevant to device risk management activities, ensuring adherence to industry standards . Lead risk management workshops and training programs, facilitating… 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
- 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
- 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
- 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
- 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
