- BioAgilytix (Durham, NC)
- …compliance protocols.Define standards, build quality assurance processes, and monitor data integrity to meet regulatory requirements, including HIPAA, GxP, ... data sharing between systems, with a focus on operational efficiency and data integrity . Data Quality & Compliance Automation: Use Robotic Process… more
- Insmed Incorporated (San Diego, CA)
- …leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical development team, and collaborates on ... observations and development of adverse trends) to ensure patient safety and data integrity .Supports strategic direction with cross functional working groups to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …expertise in GxP regulations, CSV, 21 CFR Part 11, Annex 11, GAMP 5, and data integrity - Required Deep understanding of IT system architecture, cloud solutions, ... meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for...best practices, and internal quality standards. The Lead is responsible for defining and driving the methodology,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …technological and data innovation, maintaining our facilities and assuring the integrity and completeness of all business transactions. At Novo Nordisk, you will ... Operations (USO) AI Center of Excellence. The individual will lead and manage a team of data ...strategic alignment.Effective in fast-paced environments with a focus on quality and documentation.Skilled in change management and guiding teams… more
- Merck & Co. (Rahway, NJ)
- …integrity principlesCoach and mentor staff on analytical techniques, problem solving, and data integrity as needed.Share best practices across the company to ... mindset.Exhibit exceptional leadership abilities and strong knowledge of cGMP and Data Integrity .Uphold strong values essential to fostering and contributing… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …Team, the Vice President of Preclinical Research & Development will develop and lead the all of the Institute's Contract Research activities and functions to ... fostering innovation across Lovelace's scientific functional areas, specifically:Operational Leadership: Lead the seamless daily operations of Lovelace's research facility.… more
- Twist BioScience (South San Francisco, CA)
- …MES solutions across our biomanufacturing operations. This critical role will drive efficiency, quality , and robust data integrity within a highly automated ... LIMS, QMS), and ensure compliant data flow across the biomanufacturing ecosystem. Data Integrity & Reporting: Architect and ensure the accuracy, integrity… more
- Merck & Co. (Durham, NC)
- …products. For over a century, our success has been propelled by ethical integrity , forward momentum, and an inspiring mission to achieve new milestones in global ... and Financial audits, input to QSAT actions, to ensure compliance.Support the Master Data team with general Material Handling Steward tasksDrive safety, quality … more
- Insmed Incorporated (San Diego, CA)
- …is necessary, as is knowledge of regulatory guidelines like cGMP and ICH, and data integrity principles such as ALCOA. Strong data analysis, problem-solving, ... our core values of collaboration, accountability, passion, respect, and integrity , we aim to foster an inclusive, diverse, and...(internal or external QC). May act as a program lead on a PDT as required by the business.ResponsibilitiesThe… more
- Merck & Co. (Rahway, NJ)
- …develop the next medical breakthrough. Our Company's success is backed by ethical integrity , forward momentum, and an inspiring mission to achieve new milestones in ... Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and… more
- Merck & Co. (North Wales, PA)
- …cross-functionally to monitor clinical data to ensure quality , completeness, and integrity of trial conduct.Providing tactical/scientific ... clinical/scientific execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring… more
- Merck & Co. (Rahway, NJ)
- …Collaborating cross-functionally to monitor clinical data -to ensure quality , completeness , and integrity of trial conduct. Providing ... execution of clinical protocol(s) . This may include: Serving as the lead clinical scientist on the clinical trial team. Leading medical monitoring team… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …technological and data innovation, maintaining our facilities and assuring the integrity and completeness of all business transactions. At Novo Nordisk, you will ... AI Center of Excellence (AI CoE). The individual will lead and manage a team of data ...AI/GenAI technologies and developing AI/GenAI products to deliver high quality insights with speed and efficiency Promotes a culture… more
- Genmab (NJ)
- …drug development and be part of a dynamic, collaborative team that values innovation, quality , and scientific integrity ? At Genmab, we are seeking a passionate ... our Global Medical Writing team, you will drive the development of high- quality clinical documents to support operational, medical, and regulatory activities across… more
- Merck & Co. (Durham, NC)
- …Mindset - Demonstrated ability to deliver compliant supply and achieve highest quality , lowest cost, and shortest lead -time. Strategic Thinking - Ability ... Vaccine Products. Our team works with a "Safety First, Quality Always" mindset.-As the primary point of contact for...and Activities include but are not limited to : Lead an Integrated Cross-Functional Team in Delivery of Reliable… more
- Twist BioScience (South San Francisco, CA)
- …a proven ability to scale accounting operations, and the determination to lead the department through growth and continuous improvement.Position is Hybrid - Tuesday, ... close process and reconciliationsThe account reconciliation process, safeguarding the integrity of our significant accounts that support our financial records… more
- Twist BioScience (South San Francisco, CA)
- …Senior Director of Business Development (title commensurate with experience) to lead business development initiatives across our NGS and Synthetic Biology ... and M&A prospects in line with company objectives.Deal Structuring & Execution: Lead deal negotiations from inception to close. Structure innovative, value-creating… more
- Wayne State University (Detroit, MI)
- … procedures. Oversee the resolution of data issues identified. 15% Assemble and lead the division's data integrity task force to identify data ... Alumni Affairs. Lead and manage priority initiatives related to data governance, management, clean-up, validation, enhancement, and integrity . Represent the… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Data Integrity Inspection Readiness Lead uses advanced ... quality standards, cGMP, and external agency regulations to lead preparedness for regulatory inspections and audits at AbbVie...resources needs at each site, and provide guidance on quality concerns *Ensures data integrity … more
- ThermoFisher Scientific (Greenville, NC)
- …strict compliance with 21CFR Part 11, Annex 11, and other regulatory guidelines. + Lead and support Data Integrity initiatives, proactively improving the ... our Greenville site. This outstanding opportunity allows you to lead a multidisciplinary team, ensuring the highest standards of...degree, or 6 years with an advanced degree, in quality and data integrity . +… more
