- 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 processes within… 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)
- …a foundational data governance framework, with hands-on responsibility for data quality , access control, and compliance protocols.Define standards, build ... with a focus on operational efficiency and data integrity. Data Quality & Compliance Automation: Use Robotic Process Automation (RPA) tools like UiPath or… 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 ... ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role… more
- Repligen (Waltham, MA)
- …audit schedules; serve as host for site auditsMaintain risk-based strategy for overall Quality compliance across the organization and in support of the ISO ... OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham, MA facility which has proven experience in the biotechnology… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …strict adherence to cGMPs, established manufacturing practices and procedures, and compliance with quality regulations and guidelines. This position carries ... your potential? The Position This position has primary responsibility to support Quality Control operations in the microbiology, analytical or inspection area. This… more
- Merck & Co. (Durham, NC)
- …a team of individual contributor production direct reports including safety, quality , and daily operations;Ensure that Shift(s) objectives are achieved while ... reliably supplying quality product at a competitive cost consistent with our...- that impact the efficiency and effectiveness of own unit; Compliance - Responsible for creating and sustaining a culture… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile ... size.Responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics; these metrics will… more
- Merck & Co. (Rahway, NJ)
- …The role is on-site and reports to the Sterile Pharm Ops Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS)The ... and Original Equipment Manufacturers (OEM) and vendors.Provide engineering and quality engineering (QE) support, ensuring facility, utilities and equipment are… more
- Merck & Co. (Rahway, NJ)
- …launch in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Strategic Leadership ... of team members, fostering a collaborative and innovative team environment.Regulatory Compliance and Quality Assurance:Ensure that all activities are conducted… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and ... Manufacturing Division / our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… more
- Merck & Co. (Durham, NC)
- …routine internal and external GMP and Financial audits, QSAT actions, to ensure compliance .- This is a fast-paced and multi-faceted role that provides leadership and ... external GMP and Financial audits, input to QSAT actions, to ensure compliance .Support the Master Data team with general Material Handling Steward tasksDrive safety,… more
- Merck & Co. (Durham, NC)
- …leadership skills to empower teams, solve complex technical challenges, and ensure compliance with industry standards while making a tangible impact on our ... make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant… more
- Novo Nordisk Inc. (Durham, NC)
- …improvement, & project management Serve as the Lead and SME to operate within compliance with a quality mindset that focuses on risk management & mitigation ... us make what matters. The Position Serve as a Lead & Subject Matter Expert (SME) to provide technical...team's Change Management standards and always manage assignments within compliance with a Quality Mindset that focuses… more
- Aequor (Thousand Oaks, CA)
- …Engaging with Quality and Regulatory teams to ensure alignment and compliance across the network and with various agency submissions while delivering NPI ... This "Specialist Manufacturing" role will serve as a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems, and Digital… more
- Merck & Co. (Rahway, NJ)
- …Data-Driven Decision Making, Drug Product Development, Estimation and Planning, GMP Compliance , Management Process, Manufacturing Quality Control, Medical Supply ... its' Performance Qualification and Process Simulation execution, the selected candidate will lead and contribute to the launch and regulatory certification of the… more
- Merck & Co. (Durham, NC)
- …vaccine manufacturing facility in Durham, North Carolina.- The Durham EHS Lead influences site leadership ensuring compliance with regulatory requirements, ... projects.Responsibilities:Plan, develop and implement EHS programs to assure continuous compliance with local, state and federal legislation, Company standards and… more
- Merck & Co. (Durham, NC)
- …sites.- This includes Energy Center, Vaccine Bulk and Manufacturing Facilities, Quality Labs, Material Management Storage Facility (MMSF) and projects. At times, ... problem solving sessions to support investigations and develop appropriate CAPAs which lead to program improvements.Review and approve out of tolerance (OOT) records… more
- Merck & Co. (Durham, NC)
- … compliance goals through a risk-based approach (Safety Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control).- ... Mindset - Demonstrated ability to deliver compliant supply and achieve highest quality , lowest cost, and shortest lead -time. Strategic Thinking - Ability… more
- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings .- Working independently, the ... to: - - Interacts closely with key partner organizations ( as a lead GCS Planning program representative ) such as clinical development, regulatory, quality… more
