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Biotech Project Manager (QMS) in San Diego, CA at Apex Life Sciences

Date Posted: 12/7/2018

Job Snapshot

Job Description


The PM-I will support site training and activities related to project management methodology.

The PM-I will support the management, analysis, and oversight of the QMS-DC/RM Program and also drive the execution and communication of key initiatives that align with business priorities and functional objectives.

Tasks and responsibilities:

  • Organize, initiate, plan, manage, control, and close business and technical projects end-to-end.
  • Within the project environment, provide guidance, training, and support on and use of methodology principles, themes, and processes.
  • Work with project team to draft, refine, and manage project documents such as Mandates/Charters, Business Case, and Project Plans.
  • Manage stage gate processes, meetings, documentation, and communication
  • Identify project appropriate stakeholders for projects.
  • Lead and motivate project teams.
  • Create and manage project plans in MS Project or other software tools.
  • Work with managers in Operations, Quality Assurance, Regulatory, Engineering, Reagents, and other departments as necessary to establish and build timelines.
  • Determine the requirements, deliverables, and activities associated with each project, assign internal and/or external resources to complete the necessary activities, and work with Finance to calculate project budgets and cost savings.
  • Develop and update project plans by listing activities, resources, and target dates.
  • Run weekly core team and other project meetings, prepare agendas and minutes, complete weekly project status reports, and run bi-weekly Steering Team meetings, and create PowerPoint presentations.
  • Facilitate meetings to collect cost savings ideas. Maintain adequate pipeline of cost savings projects to fulfill site business goals.
  • Prepare project monthly reports, or dashboards
  • Manage and or mentor employees on project management methodology.
  • Carries out duties in compliance with established business policies.
  • Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
  • Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
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Experience/Education:

  • Bachelors degree in science-related field
  • Requires 3+ years experience in managing projects in FDA-regulated and ISO 14971 certified industry
  • Experience in Design Controls (including Design History Files) and Risk Management
  • Prince2 or PMP (Project Management Professional) certification desired
  • Must be highly organized, detail-oriented and have prior project / program management experience in one or more of the following areas: R&D, Operations, Quality
  • Six Sigma certification is a plus
  • Knowledge of LEAN methodologies is a plus
  • Must possess exceptional leadership abilities and be a team player with effective communication / listening skills.

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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