- Russell Tobin & Associates (San Diego, CA)
- What are we looking for in our R&D Quality Risk Management Manager ? The Scientific Team at Russell Tobin & Associates is supporting an exciting pharmaceutical ... organization that has an opening for an R&D Quality Risk Management Manager near San Diego, CA!...field 6+ years R&D focused pharmaceutical expeirence in a GCP regulated environment Experience in R&D Quality Risk… more
- Merck & Co. (Rahway, NJ)
- …test scripts, test summary reports, and validation reports in alignment with GCP and 21 CFR Part 11 requirements. Risk -based validation approach: Knowledge ... Job Description Job Description: We are looking for a manager to lead and manage the validation and testing...to measure the effectiveness of the validation and testing process . Generate regular reports, highlighting test results, defects, and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- … process validation, computer system validation and calibrationPerform functional and process risk assessments in conjunction with Quality and Manufacturing ... Serve as a technical resource to improve product quality, reliability, and process capability. Support manufacturing to satisfy the quality and process … more
- Novo Nordisk Inc. (San Antonio, TX)
- …rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance) for monitoring and site management activities. Takes ownership ... approach, leveraging competencies, tools and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …safety, rights & wellbeing; data reliability; scientific integrity; regulatory & process compliance. Takes ownership to deliver upon near-term North America Clinical ... approach, leveraging competencies, tools, and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Head of R&D QA. Within assigned GPTs, facilitate the implementation of a risk -based quality management process fully embedded through trial design, execution and ... of Quality professionals at strategic project team and at GCP strategic discussions.Support the Head of RD QA with...represented at program level and along the clinical trial process in support of a proactive quality risk… more
- Merck & Co. (North Wales, PA)
- …the Medical Writer on clinical/scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates in the set up and design during ... management.May serve as a subject matter expert and/or participate on process improvement teams.Required experience and skills: Demonstrated ability to drive and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a fast-paced environment, continuous improvement, project management, change and risk management. Responsibilities - Leadership, Direction, and Strategy: Leads ... (eDTS) to ensure data standardization across programs. Identifies needs for process improvements as related to external data acquisition, and establishes external… more
- Merck & Co. (North Wales, PA)
- …Medical Writer on clinical/scientific and regulatory documents and the Study Manager on study deliverables.May provide tactical/scientific guidance to other clinical ... experience & skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH) - Ability to manage multiple competing priorities with good… more
- George Washington University (Washington, DC)
- …contracts/agreements/nonpreferred terms. Coordinates action plans for mitigation of higher risk agreements. Identifies contractual or process issues in ... is to oversee the clinical research trial contracting and budget pre-award process and represents GWU, MFA, and Hospital with minimal supervision in highly… more
- Regeneron Pharmaceuticals (Armonk, NY)
- The Senior Manager , Global Development Quality Management ( GCP ) acting as a Quality Management Lead (QML) is a key position that will provide mentorship and ... any issues to ensure compliance and for the Quality Risk Assessment process . + Ensuring and responsible...other functional areas. + Responsible for the management of GCP -compliant activities from a quality perspective in conjunction with… more
- Capital One (Mclean, VA)
- Center 1 (19052), United States of America, McLean, Virginia Senior Manager -Technology Risk Manager As a **Senior Risk Manager ** in Capital One's ... is looking for a highly motivated and experienced Senior Risk Manager to own tech risk...controls) + 1+ years exposure with Cloud Computing (AWS, GCP or Azure) + 5+ years of experience performing… more
- Capital One (Mclean, VA)
- Center 1 (19052), United States of America, McLean, Virginia Manager , Cyber Risk & Analysis- Technology Audit (Hybrid) **Capital One's Audit function is a ... + **3+ years experience in cloud computing (notably AWS, GCP , Azure) and controls, or 1+ years of conducting...New York City (Hybrid On-Site): $163,300 - $186,400 for Manager , Cyber Risk & Analysis Candidates hired… more
- Capital One (Mclean, VA)
- Center 1 (19052), United States of America, McLean, Virginia Principal Associate Cyber Risk & Analysis, Technology Audit (Hybrid) Capital One's Audit function is a ... of audits, including critical technology functions, cloud-based infrastructure, cybersecurity, risk management, application, and third-party management, as well as… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …teams are following targeted SOPs during a study. + Assist in development of risk based GCP audit strategies across clinical programs and/or studies. Plan, ... by staying **True to Life.** **Job Description** The Clinical Quality Assurance Manager reports directly to the Executive Director of Clinical Quality Assurance and… more
- Kelly Services (Burlington, MA)
- **Sr. Manager / Associate Director - Quality Assurance** **Burlington, MA** **Direct Hire** **Compensation: $125k-165k base + 10-15% annual bonus** **Candidate ... individual will report to the Sr. Director of Global GCP /GLP compliance and while working closely with the US...and work instructions. + Oversee and develop CAPA, deviation, risk analysis and change control management. + Communicate with… more
- Merck (Columbus, OH)
- …and Head of Clinical Quality Operations (HCQO), the Clinical Quality Operations Manager (CQOM)} is responsible for the execution of operational quality activities ... to implement `quality by design` within clinical development programs, using a risk -based approach. The incumbent will be responsible for the overall strategy for… more
- J&J Family of Companies (Columbus, OH)
- …Clinical Practice ( GCP ), and regulatory requirements. The Senior Local Trial Manager (Sr. LTM) actively contributes to process improvement; training and ... Senior Local Trial Manager - Immunology (1 of 3) - 2406178158W...candidate's eligibility. * Solid understanding of the drug development process including GCP and local regulatory requirements.… more
- ThermoFisher Scientific (Wilmington, NC)
- …breaches of GCP and protocol + Leads and/or participates in process /quality improvement initiatives + Provides mentorship and guidance to junior auditors **Keys ... requires some travel **Discover Impactful Work:** As a Compliance Manager within the Quality Investigation and Support team, you...GxP activities in support of project work or company process . This role plans and delivers billable quality services… more
- Capital One (New York, NY)
- …19th Street (22008), United States of America, New York, New York Senior Manager , Information Security Office Consultant At Capital One, you will help consult on ... You are pragmatic and practical in your understanding of risk and security, but also willing to know when...experience in securing a public cloud environment (eg AWS, GCP , Azure) + Experience building software utilizing public cloud… more
