- Legend Biotech USA, Inc. (Raritan, NJ)
- …daily production schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and ... investigations, support and manage change controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility… more
- BeOne Medicines (San Mateo, CA)
- **General Description** **:** The Manager , Regulatory Compliance Readiness will report to the Senior Director of Regulatory Compliance and play a key role in ... analytics and reporting, leveraging systems such as Veeva RIM to strengthen inspection readiness , deliver actionable compliance insights, and support risk-based… more
- BeOne Medicines (San Mateo, CA)
- …excellence on regular basis. + Collaborate with QA counterparts to ensure audit readiness and process control for all import and export activities, participate in ... logistics audits as needed. + Support SCL on FDA inspection , internal audit and external audit as needed on...Depot vendor's performance and report Depot metrics (KPIs) to senior management. + Ensure the requirements and business process… 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 ... including client facing meetings. + Collaborate with Sales, Project Managers, Shop Manager , and Data Analysis to meet project requirements. + Ensure all inspections… more
- Parexel (Des Moines, IA)
- …approach. The CQOM will be responsible for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow up ... provide real-time, proactive advice and guidance. + Escalate potentially significant inspection findings/compliance risks/impact to Client Senior Management. +… more
- Bristol Myers Squibb (Devens, MA)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . ** Senior Manager , Inspection Readiness (2)** **Position Summary** ... Reporting to the Director, Inspection Readiness , the Snr. Manager , Inspection Readiness plays a critical role in advancing the organization's … more
- Sanofi Group (Framingham, MA)
- **Job Title:** Audit and Inspection Manager **Location:** Framingham, MA **About the Job** We deliver 4.3 billion healthcare solutions to people every year, ... + Reviewing the internal audit reports before submission to senior management to ensure accuracy and consistency + Ensuring...management to ensure accuracy and consistency + Ensuring an inspection readiness process is in place to… more
- BeOne Medicines (Emeryville, CA)
- **Position Summary:** + Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget + Acts as ... regular updates on study progress in the region to senior management and Global Clinical Study Manager ...SOPs, ICH/GCP and all other relevant regulations + Ensures inspection readiness for study in region at… more
- Bristol Myers Squibb (Princeton, NJ)
- …Summary** Reporting to the Senior Director, Operations & Performance, the Senior Manager , Audit Intelligence Coordinator, is responsible for planning audits ... , Directed or For Cause, acquisitions, regulatory/agent distributors, labeling and inspection readiness . + Responsible for enhancing efficiency and simplifying… more
- Amgen (Thousand Oaks, CA)
- …us and transform the lives of patients while transforming your career. **Quality Assurance Senior Manager - B23 Drug Substance Mfg** **What you will do** Let's ... do this. Let's change the world. As a Quality Assurance Senior Manager , you will lead our B23 Drug Substance QA team and will serve as the Quality Leader for… more
- ThermoFisher Scientific (Plainville, MA)
- …MA | 100% Onsite** **Position Summary:** We are in search of a forward-thinking Senior Manager for Quality to lead all aspects of the Quality Operations ... therapies. You'll provide operational quality oversight and ensure compliance and inspection readiness in-line with global regulatory standards-while shaping the… more
- BMO Financial Group (Chicago, IL)
- …to join our US AML Office. This role partners closely with senior leadership and regulators to ensure AML programs meet evolving regulatory expectations. ... chance to shape regulatory strategy, build leadership presence, and partner with senior executives in a high-impact AML governance function. Ideal for professionals… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …are delivering per the scope of work + Ensure clinical project audit and inspection readiness through the study lifecycle + Supports internal audit and external ... The ** Senior Clinical Study Lead** (CSL) is expected to...study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study... inspection activities and contributes to CAPAs as required +… more
- Amgen (Holly Springs, NC)
- …waste, as part of Amgen's plan to be a carbon-neutral company by 2027. ** Senior Manager Manufacturing - Deviation Investigations** **What you will do** Let's do ... investigation quality and consistency, overseeing documentation for accuracy, compliance, and readiness for regulatory inspection . + Establish best practices,… more
- Bristol Myers Squibb (Madison, NJ)
- …of the markets related to specified asset(s) in WWMH. **Key Responsibilities** The Senior Manager of Medical Communications is accountable for the following: ... as mentor to other leads. + Ensure preparation for audit and inspection readiness + Ensuring diversity and inclusion in decision making, organization and talent… more
- Saint-Gobain (Mankato, MN)
- "This Job Matters" **_What's the job?_** The Senior Quality & Process Control (Q&PC) Manager is a strategic and operational leader responsible for driving ... - Leads the Plant Quality Council to align with strategic goals. - Ensures audit readiness via structured reviews and root cause analysis. - Acts as SME for ISO… more
- Bristol Myers Squibb (Devens, MA)
- …no better place than here at BMS with our Cell Therapy team. The ** Senior Manager Quality Systems, Site Data Integrity Lead** is responsible for ownership ... room support for Health Authority Inspections and Drive site DI Inspection Readiness solutions. + Oversight of Data Integrity Risk Assessment (DIRA) program… more
- Compass Group, North America (Ames, IA)
- …Derby, and NHL, MLB, NBA, NFL, and MLS All-Star Games. **Job Summary** As a Senior Concessions Manager , you will be responsible for leading and motivating our ... beer line cleaning * Re-stocking of concessions and bars to maximize event readiness * Ensuring all appropriate alcohol service signage is placed and that… more
- Amgen (Washington, DC)
- …us and transform the lives of patients while transforming your career. **Global Safety Senior Manager , Hematology Oncology** **What you will do** Let's do this. ... as detailed in the PV system master file and maintain a state of inspection readiness . + Represent and be the point of contact for health authority inspections… more
- GE HealthCare (MA)
- …supply. + Support internal audits and regulatory inspections, including documentation and inspection readiness . 2. Operational Framework Development + Design and ... implement a structured operational model for managing research alliances and outreach programmes. + Define governance structures, decision-making processes, and performance metrics to support alliance lifecycle management. + Identify and implement process… more
