Change Control Project Manager

Join to apply for the Change Control Project Manager role at Atrium 2 days ago Be among the first 25 applicants Join to apply for the Change Control Project Manager role at Atrium The Change Control Project Manager is responsible for supporting the cross-functional project teams executing change controls. The Project Manager will track and report project scope/timeline/milestone status associated with cell and gene therapy Type 1 Diabetes team. Must be detail-driven and have a proven history in managing and driving project success within the biotech industry. The individual requires a strong technical background, solid working knowledge of GMPs, understanding of the drug development pathway through commercialization, and willingness to pivot as priorities change. Knowledge and/or experience with cell / gene therapy methodologies and a strong understanding of risk management will be an asset. Must have excellent communication skills, written and verbal, high attention to detail, and the ability to work effectively in cross-functional, matrixed teams. RESPONSIBILITIES Partner closely with functional area leads, maintain and actively monitor integrated project plans. Identify/communicate interdependencies as well as critical path activities for the project(s) Track and monitor key milestones and decision points and work with project team members to drive the completion of changes. Effectively communicate with internal team members and key stakeholders on the status, objectives, risks, and mitigation plans associated with change control projects. Organize and maintain team communications including meeting agendas, minutes, tasks lists, and risk analyses/mitigation strategies. Update and maintain project status tools, such as a project action log and risk register. Develop and deliver project management tools and templates to manage change control team activities. Consistently perform duties within established SOPs, and in accordance with GxP requirements, where applicable QUALIFICATIONS Bachelor’s degree in engineering, life sciences or related field. A minimum of 8 years of experience in the biopharmaceutical industry. A minimum of 6 years of experience in project management of biopharmaceutical product Working knowledge of biotechnology, GMPs, and drug development lifecycle. Ability to work effectively in cross-functional, matrixed environment, prioritizing and managing multiple tasks simultaneously, integrating cross-functional issues and balancing competing priorities effectively. Expertise in Microsoft suite (Project, PowerPoint, SharePoint, Word, Excel, Outlook). Experience with other PM tools a plus (e.g., Smartsheet, Power BI, etc.). Excellent oral and written communication skills, including presentation and facilitation skills, to effectively inform key updates & issues across all levels of the organization. Strong analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective. Strong understanding of regulatory requirements (FDA, 21 CFR Part 211, EU GMP, ICH Q10) Pay Range dependent upon experience Requisition Disclaimer This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements By applying for this position, you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials, which may include your CV/Resume, email address or phone number, with Vertex. For more information on how Vertex handles your personal data related to your job application, please see Vertex’s Careers Privacy Notice. Agreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners (collectively, “Atrium Alerts”). Atrium Alerts may be sent by email, phone, or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time, please contact Atrium at . If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at Please include the job title in the subject of your email. No C2C or Third-Party Vendors Seniority level Seniority level Mid-Senior level Employment type Employment type Contract Job function Job function Project Management Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Atrium by 2x Sign in to set job alerts for “Change Project Manager” roles. Greater Boston $120,000.00-$140,000.00 2 days ago Senior Clinical Project Manager/Clinical Project Manager (Remote) Integrated Senior Marketing Project Manager Boston, MA $104,383.00-$117,431.00 1 month ago Waltham, MA $139,000.00-$191,000.00 2 weeks ago Senior PM, Project / Program Management (Eng) Wilmington, MA $108,800.00-$149,600.00 2 days ago Senior Program Manager, Strategic Project Development (Hybrid) Westwood, MA $133,170.00-$147,970.00 1 month ago Senior Manager, Global Regulatory Project Management and Strategic Planning Boston, MA $137,000.00-$215,270.00 5 days ago Field Project Manager- Security Systems Integration Greater Boston $95,000.00-$125,000.00 2 days ago Boston, MA $33,000.00-$76,000.00 2 days ago Manager, Commercial Program Management Office Assistant Project Manager - Mechanical Construction Sr Project Manager – Office of Clinical Affairs Boston, MA $121,800.00-$159,800.00 2 days ago Senior Hardware Engineering Project Manager Senior Project Manager, Transportation Planning - Taunton, MA - Boston, MA or Westfield, MA Sr. Project Manager (Must Have Medical device/ FDA regulated experience) Senior Project Manager-Licensed Site Professional (LSP)-Environmental Remediation Services Senior Medical Device Software Project Manager Sr. Technical Program Manager, Product Lifecycle Management (PLM), Global Robotics Delivery North Reading, MA $133,900.00-$231,400.00 1 day ago Boston, MA $75,100.00-$137,200.00 1 month ago Sr. Transportation Project Manager (office leader) Boston, MA $180,000.00-$250,000.00 2 days ago Boston, MA $140,000.00-$170,000.00 5 days ago Mid to Senior Hydrogeologist Project Manager (TechLaw) Lowell, MA $95,000.00-$125,000.00 2 months ago Senior Project Manager - Highway Engineering - Chelmsford, MA Manager, Program Management (Electric Utility) We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr