- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of Medical Affairs QA is ... Affairs programs. This role involves deputizing for the Sr. Director , representing the Quality organization at senior levels. The... plays a pivotal role in regulatory inspections, external audits , and high impact projects, fostering s culture of… more
- Eisai, Inc (Nutley, NJ)
- …the Quality management system. This role is responsible for Good Clinical Practice ( GCP ) and for assuring the compliance of projects, products and programs with ... issue management, and oversight of the quality management system).Conduct complex audits of sites, vendors and internal process.Train junior auditors and participate… more
- Insmed Incorporated (San Diego, CA)
- …Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Associate Director , EDC Programming will lead and oversee EDC programming, and ... automation, reporting, and data exchange solutionsEnsure all programming solutions comply with GCP , 21 CFR Part 11, and CDISC ODM StandardsData Quality &… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director , Clinical Quality Assurance position is ... Quality management system. This role is responsible for Good Clinical Practice ( GCP ) oversight, and for assuring the compliance of projects, products and programs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily ... compliance with applicable domestic and international regulations and applicable ICH/ GCP guidelines to ensure patient safety for company's products.Provide oversight… more
- Insmed Incorporated (San Diego, CA)
- …and maintain a risk-based and scientific-based quality system to support GCP .Oversee regulatory agency inspections and vendor audits .Ability to ensure ... for Millennials™, and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Executive Director , Data Management (Head of Global Data Management) sets the vision, ... for projects/studies. This individual has sufficient understanding of regulations and GCP requirements for drug development, advanced knowledge of Electronic Data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oversight groups for case processing activities and reports to the Director of PV Case Management.Responsibilities:ICSR Processing: Oversees QC activities, supports ... guides. Participates in inspection preparation activities and internal and external audits and audits CAPA preparation.Case Processing Training: Identifies case… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** The Associate Director , Good Pharmacovigilance Practice (GVP) Audits , serves as a key ... Patient Safety, and other relevant departments. In partnership with GCP and E-System Audit groups, this role helps shape,...Annual Audit Program. Reporting to the Head of GVP Audits , the Associate Director contributes to the… more
- Amgen (Washington, DC)
- …for continuous improvement. + Provide hands-on support to the Senior Manager/Associate Director in ensuring procedural compliance with GCP standards and other ... team. Join us and transform the lives of patients while transforming your career. ** GCP Quality Compliance Manager** **What you will do** Let's do this! Let's change… more
- GRAIL (Menlo Park, CA)
- …Events and CAPAs; and participating in risk management activities. + Conducting GCP audits of internal processes, clinical investigator sites, and clinical ... from inspections, audits , and emerging clinical compliance trends, in both GCP and CDx domains. + Contribute to, implement, and continuously improve quality… more
- SMBC (Charlotte, NC)
- …a competitive portfolio of benefits to its employees. **Role Description** The Director of Cloud Security Architecture will ensure bank's cloud infrastructures are ... surfacing, driving down, and reporting on cloud security issues across our AWS, GCP , and Azure environments. This role is responsible for identifying secure cloud… more
- BAYADA Home Health Care (Pennsauken, NJ)
- **POSITION SUMMARY:** The Division Director , Infrastructure Services, is a critical and trusted leadership role, leading and expanding our technology infrastructure ... that aligns with our mission and long-term goals. The Division Director is responsible for crafting a transformative cloud strategy. This role oversees the design of… more
- Ascendis Pharma (Palo Alto, CA)
- …offer a dynamic workplace for employees to grow and develop their skills. The Director , Head, ICSR Management Team reports to the Head, Global PV Operations within ... the direction of the Head, Global PV Operations, the Director , ICSR Management Team is responsible for the oversight...in the safety database and are reported according to ICH- GCP guidelines, Healthy Authority regulations and company SOPs, Work… more
- Ascendis Pharma (Palo Alto, CA)
- …a dynamic workplace for employees to grow and develop their skills. The Associate Director , PV Vendor Management Team reports to the Director , Head, PV Vendor ... supporting implementation of CAPAs as necessary + Work Closely with Ascendis GCP /PV Compliance team and Commercial organization as required to ensure oversight of… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- **Job Summary** We are seeking an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will be responsible for ... a leadership position in the conduct of clinical facility and system audits at all relevant facilities, investigator sites, and vendors (including contract research… more
- Insight Global (Coppell, TX)
- Job Description Insight Global is looking for a Director of e-Commerce on behalf of one of the world's leading casual dining restaurant companies with over 1600 ... global restaurants. The Director of e-Commerce and Engineering drives the development and.... Experience with cloud computing services - AWS and GCP . Experience working collaboratively with Product Teams Exceptional… more
- University of Pennsylvania (Philadelphia, PA)
- …health and wellness programs and resources, and much more. Posted Job Title Associate Director C, Research Job Profile Title Associate Director C, Research Job ... cognitive aging, and lifelong brain health. We are seeking an Associate Director of Clinical Research Operations to oversee the operational aspects of our… more
- College of American Pathologists (Northfield, IL)
- …at the CAP (https://www.cap.org/careers-at-the-cap) for more details Brief Description The Director , IS - Technology Delivery Advancement is a senior leadership role ... solution architects, technical leads, cloud architects, and application architects. The Director will ensure that the technology delivery processes are optimized for… more
- Takeda Pharmaceuticals (Boston, MA)
- …CPMQ team on quality compliance activities. + Provide guidance and support to GCP , PV Health Authority inspections including logistics. + Present insights to the ... Breach, Change Control, Risk Register, Regulatory Intelligence, Gap Assessment, Audits , Inspections, CAPA, SOP management, training assignment etc) **EDUCATION,… more
