GMP Project Manager

3 weeks ago

Bedford, United States a Medical Devices Technology company located in MA Full time

Project Manager, Technical Operations (Contract)


RESPONSIBILITIES

  • Demonstrate strong project management skills, including developing and managing schedules, budgets, risk identification and management, and change management.
  • Collaborate with internal and external cross-functional teams, such as Engineering, Facilities, Manufacturing, Quality, Regulatory, Supply Chain, and other relevant stakeholders, to define project requirements and ensure alignment.
  • Exhibit project leadership and make effective decisions throughout each project.
  • Foster effective teamwork by engaging with EH&S, Facilities, Engineering, Quality, Regulatory, Production, area owners, and other key stakeholders.
  • Establish and maintain effective communication channels with stakeholders, providing regular updates on project status, risks, and mitigation plans.
  • Monitor project progress, identify deviations from plans, and implement corrective actions as necessary to ensure on-time and on-budget project delivery.
  • Interface between budget and reporting tools to support management tracking, reporting, and stage-gate decision-making.
  • Utilize techniques and methods to present data in a format that promotes effective and evidence-based managerial decision-making.
  • Participate in regular meetings with the management team to provide updates on project progress, risks, mitigation plans, and decisions.
  • Collaborate with subject matter experts to develop and implement recovery plans and interventions for off-schedule and unanticipated issues impacting project progress.
  • Perform other duties and projects as assigned.


QUALIFICATIONS

  • Minimum of 10+ years of project management experience within project-based Life Science or Medical Device/Pharmaceutical companies.
  • Minimum of 8+ years of experience managing capital projects, capable of leading multi-disciplined project teams comprising employees, contractors, and consultants.
  • Strong project management skills with proven experience in managing medium to large capital projects, particularly those emphasizing cGMP cleanroom manufacturing facilities.
  • Passionate about the work, detail-oriented, analytical, with excellent problem-solving abilities.
  • Comfortable working in a fast-paced environment; able to adapt to change quickly and positively, and effectively handle various people and situations.
  • Excellent verbal and written communication skills.
  • Strong analytical, organizational, and decision-making skills.
  • Ability to learn rapidly, attention to detail, excellent computer and writing skills, and high levels of energy and self-motivation.
  • Capable of working on highly complex problems requiring analysis and rational judgment, leading to specific recommendations.
  • A team player with experience in working with multiple cross-functional teams and leading discussions.
  • Excellent listening skills, able to interpret input from diverse subject matter experts, clarify needs, and synthesize comprehensive perspectives.
  • Willingness to support 100% onsite work throughout various project phases.
  • Strong understanding of Tech Transfer, Commissioning, Qualification, and Validation processes within the medical device and pharmaceutical environment is a plus.
  • Strong budget/financial management skills relating to CapEx and OpEx spending and project cash flow forecasting is a plus.
  • Experience in end-to-end project delivery in a cGMP environment (initiation, planning, design, construction, validation, and closeout process) is a plus.
  • Detailed knowledge of MS Office, Microsoft Project, Microsoft Teams, or other project management software tools is a plus.
  • Self-motivated team leader with experience in all phases of Planning, Engineering, Manufacturing, and Quality is a plus.


EDUCATION

  • Bachelor's degree in Engineering, Life Science, Business, or equivalent experience.
  • PMP Certification or MS/MBA is a plus.

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