- Eisai, Inc (Nutley, NJ)
- …is your profile, we want to hear from you.The Director, Global IT Governance, Risk & Controls Management Lead is responsible for overseeing the entire portfolio ... process.Team Leadership: Lead the global teams in the execution of Risk and Compliance initiatives and support professional growth. Risk Management: Develop… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Cell Therapy Manufacturing Plant. In addition, the candidate must have Quality Risk Assessment experience in the pharmaceutical industry.Primary responsibilities ... and implement modifications to risk assessment plans.Key Responsibilities Follow QRM ( Quality Risk Management) process per ICH Q9, identify the risk… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary The Oncology Early Development Center (OEDC) Program Lead , who directly reports to the Head of the OEDC, supports the OEDC ... innovative, science-driven portfolios with an equally robust and agile infrastructure. The Program Lead plays a central role in supporting OEDC to drive strategy and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Validation policies and procedures in collaboration with global DX and global Quality departments. Evaluates key performance indicators and participates in SDLC ... expertise and solutions to CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer systems… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and participate in manufacturing documentation such as Protocols, Batch Records and Risk Assessments.Review and participate in quality event records, such as ... Aseptic Manufacturing LeadPosition Summary:The Aseptic Manufacturing Lead plays a critical role in overseeing aseptic manufacturing activities. A strong background… more
- Tris Pharma (Monmouth Junction, NJ)
- …implement improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in the design (and resolution) ... needs and activities in to accurately, effectively, timely and compliantly achieve quality goals and key performance metrics across multiple quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Leadership: Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including ... CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, Operations… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Operations and Sourcing (GOS) lead is responsible for owning supplier relationships, executing sourcing strategy, developing, and managing ... plans, creating and driving supplier savings roadmap, understanding and managing risk impacting supply nodes while partnering with other procurement areas to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …External Alliance Committee. b. Quality leadership team c. Develop/ chair or co- lead quality council as necessary.Ensure the vision is in place to build ... reporting purposes are readily available for presenting at senior leadership meetings.Ensure and lead the establishment of the Quality Systems for the Research … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of corrective and preventive actions, as necessary.Supports internal/external audits.Supports Quality risk assessment teams.Review/approve documents as a ... a QA Shop Floor Supervisor as part of the Quality Operations team based in Raritan, New Jersey. Role...directly supervising employees is preferred.Ability to work with and lead others in a team environment.Demonstrated ability to develop… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …review investigations, interpret results and generate technical conclusion consistent with Quality risk management principles.Must be able to effectively prepare ... cGMP manufacturing experience preferredSupport writing of SOPs for Manufacturing and Quality Risk Assessments for existing and new/changed processes.Ability to… more
- Merck & Co. (Rahway, NJ)
- …a cross-functional team.-Ensures project results meet requirements regarding technical quality , reliability, schedule, and cost.Monitors performance and ... authoring technical documentation in support of the following: process performance qualification, risk assessment, control strategy, process comparability… more
- Aequor (Thousand Oaks, CA)
- …change control records. Site performance monitoring: Report contract site performance metrics to site lead ; identify improvement opportunities for site ... degree is preferred, practical experience in GMP environments and managing quality records takes priority. Strong team leadership and facilitation skills are… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at the ... with alignment to Global Procedures.Act as a Site MES SME to support Quality Investigations, Corrections, and QMS records.Build the Site Readiness of MES for FDA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …list of congresses that would best support the company and brand objectives.- Lead planning and execution weekly meetings with Global and/or National Congresses key ... corporate awareness.- Drive collaboration and partnerships between DS Regional Congress lead (DSE, DBR ) to align on expectations, ensure global participation… more
- Aequor (Louisville, KY)
- …Operations during project planning, execution, and closeout Monitor systems to identify performance risks and implement risk reduction strategies Support new ... What stands out on resumes - Experience working with a quality assurance organization, facilities engineering, a warehouse/factory environment, experience with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsibilities. Leads complex supplier negotiations and commercial contracts for quality and value creation. Enhances the procurement capability by helping ... policies and methodologies are understood and utilized. Serve as the lead "relationship manager" to proactively deliver strategic sourcing insights, optimal value… more
- Molina Healthcare (NE)
- **Job Description** **Job Summary** The Lead Risk and Quality Performance Manager supports Molina's Risk & Quality Solutions (RQS) team by ... overseeing large programs and multiple projects supporting Molina's Risk Adjustment and Quality performance ....completeness and accuracy of EHR/HIE and supplemental data. * Lead activities and tasks across multiple teams and departments.… more
- Bank of America (Charlotte, NC)
- CFO Risk & Data Quality Testing Lead Charlotte, North Carolina **Job Description:** At Bank of America, we are guided by a common purpose to help make ... Regulations + Quality Assurance + Reporting **CFO Risk & Data Quality Testing Lead...or any other factor that is irrelevant to the performance of our teammates. To view the "EEO is… more
- BeiGene (San Mateo, CA)
- **General Description:** The Risk Based Quality Management Lead will create risk assessments for any entity (study, process, vendor, etc.) in clinical ... others as needed to analyze risks and issues using quality performance data, to identify follow up...assessments in the pharmaceutical industry + Prior experience deploying risk -based quality management programs across clinical development… more
