Senior GxP Project Manager

3 weeks ago


Cambridge, United States Zifo Full time
Job DescriptionJob Description

Location: Cambridge, MA (Hybrid)

Zifo is looking for a Project Manager with understanding of and experience in GxP processes for a client in Cambridge, MA. The Project Manager will be responsible for the delivery of various technical solutions.

Requirements

High level PM Job Description:

  • Develop an end-to-end project management plan using formal tools such as Microsoft Project or Jira.
  • Create project artifacts, such as project plans, measures, team and stakeholder communications, status reports, resource, and time management.
  • Set a cadence for project team meetings and steering committee meetings. Schedule meetings, document minutes and action items
  • Execute the project plan, monitor scope, milestones, dependencies, cost, project reporting, RAID, communication, escalations
  • Understanding of the GxP process and closely monitor the project scope change through formal change control mechanism.
  • Manage project financials such as forecast and monitor them against the project budget. Develop project or program budgets.
  • Adhere to project governance activities as outlined by the S&O.


General Project Management Skills:

  • Ultimately responsible to manage high priority projects with many stakeholders and several smaller workstreams to meet company needs. Projects are both technical and non-technical or technical in nature.
  • Responsible for managing risks, communications, budgets, procurement, timelines, resources, quality and scope in executing projects within the Project Management Methodology
  • Ensure projects are implemented within stated goals and timelines.
  • Will prepare and/or present data, results and reports to peers, project managers, and management. Comfortable interacting with and presenting to all levels of management
  • Anticipates and resolves conflicts with a win-win mentality
  • Able to concurrently manage multiple projects and priorities, using best practices and industry standards
  • Be an expert in Project Management within the corporate and a matrixed environment


Technical PM Responsibility:

  • Manage/lead entire project or service including technical solution, implementation, support and quality. Understand and direct/participate in all phases of project implementation on large projects
  • Prioritize work and schedules
  • Review project team deliverables to ensure quality (design walk-through, test results, etc.) and adherence to standards/ regulatory requirements
  • Interact with customers to understand their business and to anticipate IT solutions based on business and technical knowledge. Manage (educate and influence) the business project sponsor
  • Participate in the budget process and be accountable for project budget on small/medium size projects.
  • Provide direct supervision and mentoring of project team member's during the project. Provide project performance feedback to the team member's supervisor/manager
  • Participate in the research, analysis, selection, and implementation of new tools, technologies and/or services


In delivery to the Project Management Office:

  • As a change agent, works with a cross functional teams to develop and deploy new business process and improve existing business processes.
  • May collect data to monitor & report on the progress of project(s); then assembles the preliminary analysis of the data
  • Assesses project or business process issues and develop solutions in order to meet objectives, which may include quality, customer satisfaction, productivity and costs
  • Using project management tools, develops mechanisms for monitoring project progress and for intervention and problem solving with project managers, line managers and other manufacturing managers
  • Approves team deliverables for project completion and focuses teams on ensuring completion of deliverables based on agreed to timelines

Qualifications:

  • Bachelor’s/Master’s degree or equivalent in a Life Sciences or IT field is mandatory
  • Minimum 10 years of experience as a Business Technology Consultant/Project Manager
  • Minimum 5 years of experience working with Customer/Client focused delivery model & Global solution deployment, preferably in the pharmaceutical /Life sciences industry
  • Previous Experience with large scale implementation of Cloud based COTS systems

A successful Zifo-ite is:

  • Independent, Self-Motivated & Results driven
  • Willing & able to quickly acquire new Technical Skills & Business Principles
  • A critical thinker who possesses logical reasoning
  • Curious and always looking for creative solutions to complex problems

Benefits

About Zifo:

CURIOSITY DRIVEN, SCIENCE FOCUSED, EMPLOYEE BUILT. Our culture is unlike any other, one where we debate, challenge ourselves, and interact with all alike. We are a curious bunch, characterized by our passion to learn and spirit of teamwork. Zifo is a global R&D solutions provider focused on the industries of Pharma, Biotech, Manufacturing QC, Medical Devices, specialty chemicals and other research-based organizations. Our team’s knowledge of science and expertise in technology help Zifo better serve our customers around the globe, including 7 of the Top 10 Biopharma companies.

We look for Science – Biotechnology, Pharmaceutical Technology, Biomedical Engineering, Microbiology etc. We possess scientific and technical knowledge and bear professional and personal goals. While we have a “no doors” policy to promote free access within, we do have a tough door to walk in. We search with a two-point agenda – technical competency and cultural adaptability.

We offer a competitive compensation package including accrued vacation, medical, dental, vision, 401k with company matching, life insurance, and flexible spending accounts.

If you share these sentiments and are prepared for the atypical, then Zifo is your calling

Zifo is an equal opportunity employer, and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.



  • Cambridge, United States Zifo Full time

    Job DescriptionJob DescriptionLocation: Cambridge, MA (Hybrid)Zifo is looking for a Project Manager with understanding of and experience in GxP processes for a client in Cambridge, MA. The Project Manager will be responsible for the delivery of various technical solutions.RequirementsHigh level PM Job Description:Develop an end-to-end project management plan...

  • Senior Engineer

    2 days ago


    Cambridge, Massachusetts, United States Vedanta Biosciences Inc Full time

    About the RoleThe Senior Process Engineer will be responsible for working cross-functionally to design, scale, and implement processes in Vedanta's manufacturing facilities. This individual is a motivated and experienced process engineer and will focus on operations support, project execution, and tech transfer.Key ResponsibilitiesProcess Validation: Support...


  • Cambridge, United States LS Solutions Full time

    Position: IT R&D Quality Systems Project Manager (Veeva Connectors)Duration: 6+ months ContractLocation: RemoteJOB DESCRIPTION Our client is seeking a highly motivated and experienced IT R&D Quality Systems Project Manager to support a critical initiative of implementing Veeva connectors for Veeva Vaults and other R&D Systems as needed. This position...

  • Senior Project

    3 weeks ago


    Cambridge, United States Zifo Full time

    Job DescriptionJob DescriptionLocation: Cambridge, MA/East CoastZifo is looking for a Senior Project/Program Manager with experience in validated systems application development and GxP processes to fill some upcoming, anticipated opportunities in Cambridge, MA. The Project Manager will be responsible for the delivery of various technical solutions. This is...

  • Senior Project

    3 months ago


    Cambridge, United States Zifo Full time

    Job DescriptionJob DescriptionLocation: Cambridge, MA/East CoastZifo is looking for a Senior Project/Program Manager with experience in validated systems application development and GxP processes to fill some upcoming, anticipated opportunities in Cambridge, MA. The Project Manager will be responsible for the delivery of various technical solutions. This is...


  • Cambridge, Massachusetts, United States Zifo Full time

    Position Overview:Zifo is seeking a skilled Program Coordinator with a robust understanding of GxP methodologies to oversee projects effectively. The individual will be tasked with ensuring the successful delivery of diverse technical initiatives.Key Responsibilities:Project Management Essentials:- Formulate a comprehensive project management strategy...


  • Cambridge, Massachusetts, United States WHITE COLLAR TECHNOLOGIES INC Full time

    Job OverviewWe are seeking a GxP Compliance Validation Specialist to provide essential support to our Quality Control Analytical department. This role is pivotal in ensuring the CGMP status of our QC Instrumentation hardware and software while conducting comparability studies for the integration of analytical assays on new instruments.Key...


  • Cambridge, United States Umanist Staffing LLC Full time

    Job DescriptionJob DescriptionJob Type: Contract& & & & Work Type: Hybrid (Travel is required)& Duration: 5& Months& & & Job Description:& & Enterprise-Level Assessment: Lead the assessment of GxP systems across the enterprise to ensure compliance with regulatory requirements and industry best practices.& Risk Management:& Develop and implement risk...


  • Cambridge, United States Blueprint Medicines Full time

    Pharmacovigilance Systems Senior Manager Cambridge, MA Requisition Number: 24-606   How will your role help us transform hope into reality? Job Duties: Manage the day-to-day operational activities of the PV Systems and ensure that performed tasks comply with Drug Safety and Pharmacovigilance SOPs and policies, best industry standards, and applicable...


  • Cambridge, United States QurAlis Full time

    ABOUT THE COMPANY At QurAlis, we are neuro pioneers on a quest to cure. We work with a relentless pursuit of knowledge, a precise attention to craft, and an optimistic mindset to discover and develop effective precision medicines that will alter the trajectory of amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), and other neurodegenerative...


  • Cambridge, United States QurAlis Full time

    ABOUT THE COMPANY At QurAlis, we are neuro pioneers on a quest to cure. We work with a relentless pursuit of knowledge, a precise attention to craft, and an optimistic mindset to discover and develop effective precision medicines that will alter the trajectory of amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), and other neurodegenerative...


  • Cambridge, United States Connect Life Sciences Full time

    Senior Clinical Project ManagerThe Senior Clinical Project Manager (Sr. CPM) is responsible for leading and successfully delivering complex projects within Development Operations. This role involves close collaboration with stakeholders and cross-functional teams to ensure project scope, timelines, and quality standards are consistently met. The Sr. CPM is...


  • Cambridge, United States Connect Life Sciences Full time

    Senior Clinical Project ManagerThe Senior Clinical Project Manager (Sr. CPM) is responsible for leading and successfully delivering complex projects within Development Operations. This role involves close collaboration with stakeholders and cross-functional teams to ensure project scope, timelines, and quality standards are consistently met. The Sr. CPM is...


  • Cambridge, United States Blueprint Medicines Full time

    Pharmacovigilance Systems Senior ManagerScroll down to find the complete details of the job offer, including experience required and associated duties and tasks.Cambridge, MARequisition Number: 24-606 How will your role help us transform hope into reality?Job Duties: Manage the day-to-day operational activities of the PV Systems and ensure that performed...


  • Cambridge, United States WHITE COLLAR TECHNOLOGIES INC Full time

    Job DescriptionJob DescriptionResponsibilities:· Provide support to the QC Analytical department for activities required to maintain CGMP status of QC Instrumentation hardware and software and to perform comparability studies for the implementation of analytical assays on new instrumentation. This scope includes QC Instruments (both portable and...


  • Cambridge, United States Motion Recruitment Full time

    Our client, an Ivy-League University, is urgently looking to add a Technical Project Manager to their team on a contract basis.Open to Remote or Hybrid Candidates! W2 Contract eligible for full benefits! Initial 3-month contract with potential to extend!As a Senior AI Technical Project Manager, you will play a pivotal role in bringing AI-powered solutions to...


  • Cambridge, United States Motion Recruitment Full time

    Our client, an Ivy-League University, is urgently looking to add a Technical Project Manager to their team on a contract basis.Open to Remote or Hybrid Candidates! W2 Contract eligible for full benefits! Initial 3-month contract with potential to extend!As a Senior AI Technical Project Manager, you will play a pivotal role in bringing AI-powered solutions to...


  • Cambridge, United States Vedanta Biosciences Inc Full time

    Title: Senior Process EngineerLocation: Cambridge, MAReports to: Associate Director, Technical OperationsAbout Vedanta Biosciences:Vedanta Biosciences is a late-stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases. The company's lead assets include potential first-in-class oral therapies, VE303, a Phase 3-ready...


  • Cambridge, United States TBWA\Chiat\Day Full time

    Reports to: Associate Director, Technical Operations About Vedanta Biosciences: Vedanta Biosciences is a late-stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases. The company’s lead assets include potential first-in-class oral therapies, VE303, a Phase 3-ready candidate for recurrent C. difficile infection,...


  • Cambridge, United States Planet Pharma Full time

    Responsibilities:The Quality Systems Contractor will work to support the implementation of process improvements and workflow optimizations within Document Control and Quality Systems. Summary of Key Responsibilities:Support updates to Veeva meta-data, including review of existing configuration and making necessary changes required for system...