- Merck & Co. (Rahway, NJ)
- …compliance and operational excellence in the laboratories. Maintains a state of inspection readiness . Performs proactive resourcing planning and risk assessment ... Chromatographic Techniques, Decision Making, Dosage Forms, GMP Compliance, Immunochemistry, Inspection Readiness , Learning New Concepts, Microbiological Analysis,… more
- Bayer (Whippany, NJ)
- …and diverse minds to make a real difference, there’s only one choice. Senior Director , Digital Governance & LMR Lead The Senior Director , Digital Governance & ... YOUR TASKS AND RESPONSIBILITIES The primary responsibilities of this role, Senior Director , Digital Governance & LMR Lead, are to: Oversight of External… more
- Eisai, Inc (Nutley, NJ)
- …governance frameworks, and compliance with ICH/GCP guidelines and local regulations, ensuring inspection readiness and adherence to corporate standards.As a key ... Oversees global outsourcing activities, and collation of documentation to ensure inspection readiness .Provides guidance to Eisai affiliated companies in… more
- Eisai, Inc (NJ)
- …the Director drives operational excellence, risk mitigation, and inspection readiness while fostering cross-functional collaboration and innovation.The ... your profile, we want to hear from you. The Director of Clinical Outsourcing is responsible for leading the...outsourcing team and oversees collation of documentation to ensure inspection readiness on a regional Provides guidance… more
- Merck & Co. (Rahway, NJ)
- …& quality requirements on GCS equipment and infrastructureSupport Permanent Inspection Readiness and Continuous Improvement expectations.Manage global small ... Engineering Standards, Establishing Contacts, Estimation and Planning, GMP Compliance, Inspection Readiness , Integrated Product Teams, Intercultural Collaboration,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diligence assessments of GMP facilities and or CMOs as deemed necessary. Ensure inspection readiness are adequately performed and may support and/or lead ... GxP related functions in best auditing practices in order to ensure the inspection readiness level of each site and maintain a capacitation program for GMP staff… more
- Insmed Incorporated (NJ)
- …closely with our QA organization to implement and manage a process for Inspection Readiness .Contributes to the development and review of regional/global policies ... 1-2 indications within one compound, in collaboration with the Senior Director , Clinical Operations. Ensures consistent and successful execution of operational… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …sites. In addition, this role will support Compliance initiatives, such as inspection readiness , metrics implementation and review, overall regulatory compliance ... landscape to stay informed of regulatory trends and developmentsAssist with inspection readiness efforts and program implementation across all sites.Manage… more
- Caris Life Sciences (Tempe, AZ)
- …bigger than yourself, Caris is where your impact begins.** **Position Summary** The Director of Diagnostic Quality Analytics & Reporting will build and lead the ... closely with Quality, Lab Operations/Management, and Executive Leadership, the Director will architect the dashboards, automated alerts, and narrative reporting… more
- BeOne Medicines (San Mateo, CA)
- …identify potential risks to clinical operations related to process and inspection readiness ; operationalize mitigation strategies in collaboration with key ... stakeholders/leadership** **Strategically evaluate and implement solutions to address any operational geographic gaps related to ensuring clinical operations process team is set up for optimal execution** **Optimize current state clinical operations processes… more
- Merck & Co. (Durham, NC)
- …commercial product teams Supports and continually enhance the ongoing site Permanent Inspection Readiness status Obtain and maintain cutting-edge knowledge and ... Job DescriptionThe Quality Associate Director /GMP Lead Site Auditor will have leadership responsibility...risk communication related to the totality of audit and inspection findings at the site.- Ability to lead an… more
- MISTRAS Group, Inc. (Houston, TX)
- …feasibility and mitigate inspection risks. + Make informed decisions on inspection readiness , tool runs, and operating parameters. + Provide real-time ... and bonus eligibility. + Maintain minimum inventory levels and ensure tool readiness . + Support workflow optimization and remove operational bottlenecks. + Lead… more
- Northrop Grumman (Plymouth, MN)
- …of what's possible. From global defense to sustainment and modernization to mission readiness , your experience and ability will make it a reality. Our programs are ... , we have an exceptional opportunity for a **Test Inspection Manager** to support our Armament Systems business site...share in company results. Employees in Vice President or Director positions may be eligible for Long Term Incentives.… more
- Air National Guard Units (Peoria, IL)
- …to assist commanders in identifying areas of risk and allocating resources. Construct inspection and exercise plans that assess unit readiness , compliance, and ... reports that document compliance status, deficiencies, recommendations, and strengths. Utilize inspection and readiness systems such as MICT, IGEMS, IGEMS-C,… more
- Lilly (Pleasant Prairie, WI)
- …consumability of data to drive process improvements. This role ensures compliance and inspection readiness of the data integrity and data management program at ... the site and align with corporate objectives. The Associate Director , Quality Assurance, will also provide computer system quality...to drive process improvements. This role ensures compliance and inspection readiness of the data integrity and… more
- Morehouse School Of Medicine (Atlanta, GA)
- …monitoring plans, risk assessments, and execute Operations-assigned CAPAs; maintain inspection - readiness checklists, eReg/ CTMS documentation quality, and ... Clinical Trials Operations (CTO) Director - Clinical & Operational Implementation Bookmark this...site execution, MCA , research billing workflows, and audit readiness from an operations standpoint. * Facility with CTMS… more
- Lilly (Raleigh, NC)
- …standardized global business processes. + As the subject matter expert, ensure inspection readiness , directly interact with Health Authorities during inspections ... provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly… more
- Vitalief (Philadelphia, PA)
- …funded (NIH) research. The role emphasizes executive partnership, performance accountability, inspection readiness , and service excellence across a complex, ... competency frameworks, and succession planning. + Quality, Compliance & Inspection Readiness : Maintain enterprise-wide responsibility for regulatory compliance,… more
- Lilly (Lebanon, IN)
- …procedural interpretation and training, regulatory agency inspections and maintenance of inspection readiness . This role may also support external manufacturing ... to prioritize + Demonstrated problem-solving and decision-making skills + Previous regulatory inspection readiness and inspection execution experience +… more
- Air National Guard Units (Moffett Field, CA)
- Summary This DIRECTOR OF INSPECTIONS is located in an Air National Guard (ANG) Wing Inspector General (IG) Office and is part of the CA 129 RQW. Responsibilities ... funding becomes available or position becomes unencumbered. The primary purpose of the DIRECTOR OF INSPECTIONS, GS-1801-12, is to serve as the focal point for… more
