- Tris Pharma (Monmouth Junction, NJ)
- …trials.Oversee and manage the qualification and auditing process and other GCP QA inspectional activities.Responsible for inspection readiness related to ... Junction, New Jersey, Tris has an immediate opening for a full-time permanent Director /Senior Director , Clinical Quality Assurance. This is a hybrid position.… more
- BeiGene (San Mateo, CA)
- **General Description:** The Director , GCP Inspection Management , is responsible for: + Supervising activities related to inspection readiness, ... + Act as R&D Quality Delegate for the Executive Director , R&D Quality, as needed + Support development of...+ Promote continuous improvement + Provide support with the GCP Inspection Management Team for… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …together. **Job Description** You will act as a primary point-of-contact for R&D Quality inspection management and act as an inspection readiness ambassador, ... maintenance of a comprehensive and connected framework for continually improving inspection management , supporting R&D personnel with the readiness, preparation,… more
- Taiho Oncology (Princeton, NJ)
- …or CRO any quality issues + Ability to conduct any level of PAI GCP Inspection Readiness; experience with Regulatory Inspections required; solid understanding of ... Value Proposition: New and exciting opportunity to join Taiho's GCP Quality Assurance Team as a Director ... QA roles with all Clinical Trials Teams, the GCP Audit Program, regulatory inspection readiness, conduct… more
- Pfizer (Collegeville, PA)
- …and asset teams for asset and study quality risk management , quality issues management and general GCP guidance. **ROLE RESPONSIBILITIES** Level 1 GCP ... and study level information is appropriately incorporated within the GCP QMS. + They will be the initial escalation...within Pfizer Oncology Quality governance processes / meetings. + Inspection Readiness and Preparation, CAPA management -… more
- ThermoFisher Scientific (Austin, TX)
- … Health Authority Inspection . Additionally, you will coordinate and support inspection management tasks for global health authority inspections of PPD. Key ... will you do in this role? As an Associate Director , Clinical QA-Regulatory Inspections at Thermo Fisher/ PPD Clinical...Responsibilities: Support direct management in developing and operationalizing the inspection … more
- Bristol Myers Squibb (New Brunswick, NJ)
- …health, etc.) + Oversee the development and maintenance of an effective inspection management framework supporting clinical trials. + Provide leadership and ... oversight plans, including internal and external audit strategies and inspection readiness/ management strategies. + Oversee the planning,...oversight for GCP Inspections ensuring effective readiness, preparation, management ,… more
- Bristol Myers Squibb (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** Senior Director , Risk Management and Central Monitoring Position is a ... making at site, study, country, portfolio level. The Senior Director , Risk Management and Central Monitoring, is...enabling them to lead execution of the Risk Based Management Framework, enhancement of quality, compliance and inspection… more
- Kelly Services (Alameda, CA)
- …Bay Area** Type: Direct Hire Shift: M-F 8a-5p Salary: 200K-250K + DOE The Senior Director will lead QA compliance across GCP , PV, and GLP functions, ensuring ... data integrity through risk-based audits and Quality Risk Management (QRM). Key responsibilities include tracking metrics, driving continuous improvement, and… more
- BeiGene (San Mateo, CA)
- …study protocol, SOPs, ICH/ GCP and all other relevant regulations. + Ensures inspection readiness for studies in region at any point in time throughout the study ... **General Description:** _Study management responsibilities:_ + Accountable for regional study or...Accountable for regional study or portfolio delivery with appropriate inspection readiness quality, within agreed timelines and budget +… more
- BeiGene (San Mateo, CA)
- The Associate Director (AD) Clinical Study Management leads both indirect and direct reports, external partners, consultants, vendors and external budget to ... of contracts and/or work order changes prior to submission to senior management for approval. The AD CSM establishes and maintains effective communication and… more
- Bristol Myers Squibb (Princeton, NJ)
- …their personal lives. Read more: careers.bms.com/working-with-us . Job Title: Executive Director , Global Trial Management , TA Head for Hematology/Oncology Early ... with clinical compliance and other functions, support strict adherence to GCP principles, enabling ongoing inspection -readiness and successful implementation of… more
- BeiGene (Emeryville, CA)
- …study protocol, SOPs, ICH/ GCP and all other relevant regulations. + Ensures inspection readiness for studies in region at any point in time throughout the study ... **General Description:** _Study management responsibilities:_ + As part of the regional...Accountable for regional study or portfolio delivery with appropriate inspection readiness quality, within agreed timelines and budget +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …that specializes in process improvements, procedural documents, and quality and inspection readiness for Clinical Operations. The Associate Director , will ... to ensure quality, proactively identify risk, mitigate non-compliance and support inspection readiness activities. The position will partner closely with Research &… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …+ Interface with key clinical and regulatory functional area leads + Project Management + Medical Director (s) + Procurement + Clinical Finance **THIS ROLE ... An Associate Director Program Operations Leader (POL) is responsible for...Leader (POL) is responsible for leadership and overall strategic management of one or more complex programs in Clinical… more
- CSL Behring (King Of Prussia, PA)
- …large global clinical trials (pharmaceutical or CRO).** **Budget forecasting and management experience.** **Knowledge of ICH guidelines/ GCP and its applicability ... is a Hybrid role. You will report to the Director Clinical Portfolio Execution. You will develop the operational...end-to-end study delivery of all operational activities and budget management relating to assigned clinical studies. You will manage… more
- BeiGene (San Mateo, CA)
- **General** **Description:** The Senior Director of CMO and Distribution Logistics, Clinical Supply Chain is responsible for overseeing the Clinical Supply Chain ... leadership over the DP Supply Planning, CMO operation and Distribution management . Ensures organization effectively manages vendor relationships and activities and… more
- BeiGene (San Mateo, CA)
- …and the need for process improvements. + Assisting R&D Quality Inspection Management Teams and cross-functional compliance functions, in developing/adjusting ... **General Description:** The Associate Director R&D Quality Excellence, Analytics, and Innovation is...maintaining a proactive, risk-based, and phase appropriate approach to GCP , GVP and GLP Quality Assurance. This role serves… more
- HistoWiz (Long Island City, NY)
- …to support our customers' growing histology needs. Who are you? The Senior Manager/ Director of Quality is responsible for overseeing the quality and compliance of ... lab operation. Oversees the development, implementation, and maintenance of the quality management system in accordance with the GLPs. Leads internal audits and… more
- Bristol Myers Squibb (Madison, NJ)
- …of industry trends and emerging technologies supporting clinical trial data acquisition and management . + Expert knowledge of GCP /ICH guidelines. + Proven track ... at work and in their personal lives. Read more: careers.bms.com/working-with-us . Director , GDM Process Excellence is a leadership role accountable for the… more
