- Novo Nordisk Inc. (Durham, NC)
- …SME to operate within compliance with a quality mindset that focuses on risk management & mitigation Lead the training & implementation of effective change ... us make what matters. The Position Serve as a Lead & Subject Matter Expert (SME) to provide technical...standards and always manage assignments within compliance with a Quality Mindset that focuses on risk management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …database release, data review and cleaning, database lock), to ensure data quality /integrity and regulatory complianceEnsures that Data Management Plans ... global data management strategy across regions and across studies/programs. Lead DM resource model internalization for both strategy and implementation in terms… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the Novo Nordisk US Operations (USO) AI Center of Excellence. The individual will lead and manage a team of data scientists, including AI/ML experts and ... methodologies and technologies to deliver actionable insights and propel data -driven decision-making.Promotes a culture of creativity and risk -taking,… 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. (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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM ( Risk Based Quality Monitoring) sets the vision and strategy for the RBQM ... in supporting RBQM activities.- Technical: Provides technical guidance in Quality by Design. Lead the team to... Surveillance, targeted source document verification and targeted source data review. Lead the team to develop… more
- Merck & Co. (Durham, NC)
- …and Financial audits, input to QSAT actions, to ensure compliance.Support the Master Data team with general Material Handling Steward tasksDrive safety, quality ... and process enhancements throughout the supply chain - Project Management Lead and sponsor all Supply Chain Logistics initiatives surrounding qualification support… more
- Merck & Co. (San Francisco, CA)
- …execution of our Company's DSCS Digital Strategy to enable a seamless data infrastructure that drives increased speed, capacity and robustness across organizational ... interdependent across our functional areas, Discovery, our Manufacturing Division Quality , and BARDS, to name a few, and with...with a strong background in the biotech industry to lead digital transformation initiatives. This role will focus on… more
- Merck & Co. (Durham, NC)
- …Review Meetings (with External Partner).-- Compliance:-Achieve compliance goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk ... investment requirements, and provide Operations input into Supply and Quality Agreements.- Launch Supply Risk Mitigation:-Ensure External Partner… more
- Formation Bio (New York, NY)
- …obligations to maximize service quality and efficiency. Partner with Legal, Quality Assurance and Data Governance teams to understand and monitor vendor ... ensuring cost-effective and value-driven vendor partnerships. This individual will lead vendor negotiations, implement procurement best practices, and collaborate… more
- Insmed Incorporated (San Diego, CA)
- …supporting clinical GMP drug substance and drug product production and quality control operations. This role combines technical leadership in equipment lifecycle ... and qualification of instruments and equipment for GMP manufacturing and quality control (QC), with the flexibility to support both large-scale production… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... across clinical, commercial, and enterprise domains. This role involves applying data interpretation and trend forecasting to identify market trends, leading a… more
- Merck & Co. (Upper Gwynedd, PA)
- …including assessment of the probability of regulatory success together with risk mitigation measures.- Lead development and execution of global product ... include, but are not limited to:Regulatory Responsibilities: Serve as a CMC Product Lead for assigned products and be accountable for the delivery of all regulatory… more
- Merck & Co. (Rahway, NJ)
- …background in analytical methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and ... accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for… more
- Merck & Co. (Rahway, NJ)
- …cross-functional team.-Ensures project results meet requirements regarding technical quality , reliability, schedule, and cost.Monitors performance and recommends ... the following: process characterization (PC), process performance qualification (PPQ), risk assessment (RA), control strategy, process comparability reports, and/or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …reviews CPI/KPI/GPI where applicableParticipates in the development of calibration data sheets, metrology job plans and associated master plansParticipates in ... programsAssists in the creation, tracking and completion of metrology related SOPs, quality events, CAPAs, Out of Tolerance (OOT) situations and other technical… more
- Merck & Co. (Rahway, NJ)
- …and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and commercial launch. The ... scientific excellence and compliance with our company's procedures for recording time, data entry, and trainings. The successful candidate will serve as a sounding… more
- USAA (Phoenix, AZ)
- …improve processes and systems to increase member conductivity, employee experience, risk mitigation, and operational efficiency. Directs the oversight of P&C ... Underwriting supplier programs leveraging available products to improve risk management and operational efficiency. Collaborates cross-functionally to identify/implement… more
- Citigroup, Inc. (New York, NY)
- …commitments and enhance risk management. Experience leveraging glossary, lineage, and data quality tools to drive governance Experience creating and being a ... The Data Risk Appetite Sr Group Manager,...Most Relevant Skills Constructive Debate, Data Governance, Data Management, Data Quality , Internal… more
- JPMorgan Chase & Co. (Plano, TX)
- …use cases and credit risk processes. Analyze datasets for completeness and data quality issues. Identify data automation opportunities using systemic ... to be best-in-class. As a key member of the Data Strategy Team within the Wholesale Credit Risk...and publish data lineage. Establish a robust data quality program to ensure data… more
