| GxP Program Manager with 8+ years of experience in a GxP project delivery role & PMP or PMI-ACP certification required; CSM certification required at Boston, Massachusetts, USA |
| Email: [email protected] |
| From: Narayana Rao 3MKLLC, 3MK Software Solutions LLC [email protected] Reply to: [email protected] Hello, Greetings for the day!!! Please review the below role and advise the best time to connect with you. If you are interested, you can reach me on LinkedIn: www.linkedin.com/in/narayanarao2 and share resumes to [email protected] Hiring: GxP Program Manager with 8+ years of experience in a GxP project delivery role & PMP or PMI-ACP certification required ; CSM certification required Location: Boston, MA (Onsite position, No Remote) Rate: Open / hr Contract: Long Term Project Role & Project Description: The purpose of the GxP Program Manager role is to manage a highly complex GxP project within the Research Informatics (RX) function within the Biomedical Research (BR) division of Pharmaceuticals. Because of the complexity of the project, including the GxP components, two global locations/time zones, and its criticality to Biomedical Research, it will be managed as a program. The program is called Program Bridge = Bioanalytical Revamp for Improved Deliverables with Greater Efficiency. The purpose of this program is to build two regulated bioanalytical labs to enable clinical PK/PD/IG deliverables. This will involve re-internalizing FIH/Ph2a GCP deliverables and refreshing the clinical biologics bioanalytical outsourcing model for greater efficiencies within BR. The program will consist of four major workstreams to deliver the above outcomes. Only Program Manager-level candidates meeting all of the experience, education and qualification requirements below will be considered. Major Accountabilities: Lead the global BR/RX Program Team to deliver program outcomes in each of its workstreams and phases, managing all project and program management aspects in each phase Manage global cross-functional managerial, business and technical teams through successful program delivery, on time and within budget, and at the quality level required Proactively manage the programs risks and issues, resolving each promptly and fully to limit impact on progress and escalating as necessary Facilitate collaborative decision making and issue resolution Ensure full compliance with GxP requirements for all relevant areas of the program Ensure adherence to global Information Security and Quality standards and policies for all products/services. Ensure Regulatory Compliance (e.g. GLP & GCP) standards and policies for GxP products/services. Experience Requirements (Core Skills and Capabilities): Experience successfully managing bioanalytical labs projects or equivalent 8+ years of experience in a GxP project delivery role accountable for business outcomes Demonstrated ability to effectively manage a global program/project team of technical, scientific and business associates Demonstrated success implementing global IT solutions, platforms and infrastructure supporting GxP scientific processes and decision making in a pharmaceutical research or biotech environment Strong track record of successful delivery of programs/projects in a highly complex global environment Effective use of agile and adaptive project/program management approaches Education and Qualification Requirements: University Degree PMP or PMI-ACP certification required ; CSM certification required 8+ years of GxP expertise Demonstrated success leading GxP laboratory buildouts and operations projects Language Requirements: English fluent, German helpful Thanks & Regards, Narayana Rao Sr Manager (Recruitments) 3MK Software Solutions LLC Email: [email protected] Website: http://3mkllc.com/ Connect me on Linkedin too for daily updates and REQUIREMENTS: linkedin.com/in/narayanarao2 Note: WANT TO GET MY DIRECT CLIENT REQUIREMENTS DAILY Please click on below link and clink on Ask to join Group Keywords: information technology Massachusetts |
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| Wed Dec 20 22:35:00 UTC 2023 |