31 Jan
Program Manager - Quality Projects
California, Santarosa , 95402 Santarosa USA

Vacancy expired!

Lab Ops Program Manager – Quality ProjectsLocation: Santa Rosa, CA, ONSITEThe role is a quality focuses position between 2 departments of Quality Assurance and the Lab. The candidate will facilitate communication between the two departments and synchronize the processes. In this role, you will:

  • Oversee and manage QA projects within the business unit.
  • Coordinate with cross-functional teams to include Operations, Quality and Regulatory to ensure that all deliverables are completed correctly and delivered on time.
  • Coordinate internal resources and third parties/vendors for the flawless execution of projects
  • Ensure that all projects are delivered on-time, within scope and within budget
  • Develop detailed project plans and handle reporting on project progress and achievement of key milestones.
    • Develops cost analysis, creates and manages the integration of project schedules, program budget.
    • Assist and support QIPs (Quality Improvement Projects) and assist with laboratory review of nonconformances and CAPA (Corrective Action Preventative Action) review
  • Develop project charters, status reporting presentations and communicating effectively to senior management.
  • Write Standard Operating Procedures (SOPs) and upgrading Quality Systems to align to new requirements.
  • Leads the teams through best practices in planning.
  • Provide training or mentoring to other project leaders to elevate efficiencies and facilitate compliance.
  • Provides program management expertise for medium to large scale programs.
    • Works closely with various disciplines within Quality, Regulatory and Lab Operations, and establishes program plans and objectives.
    • Tracks progress and communicates proactively the impact of changes (e.g. scope, cross functional resources, timelines, costs, etc.) to key stakeholders.
    • Ensure that teams are equipped and prepared per the appropriate phase requirements to present at key business performance review meetings; that all appropriate stakeholders within and outside the BU are apprised of review meetings and the results thereof.
  • Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per NLCP, CAP, ISO, FDA, and other regulatory agencies.
  • Bachelor’s Degree in Administration, Sciences, Engineering, Humanities. Other: Project Management track record, Supervisory Experience.
  • This candidate will need a background in quality assurance/validation in clinical environment
  • Medical devices sector experience
  • Agile expert
  • Minimum 5 years’ experience in Quality or Operations or R&D within the healthcare or biotechnology industry.
  • Extensive experience leading projects to completion.
Preferred qualifications:
  • Extensive experience in developing and managing projects using MS project or other project management tools.
  • Demonstrated ability to effectively and constructively communicate across departmental disciplines while pursuing project goals
  • Proven ability to provide sound conclusions and recommendations.
  • Demonstrated organizational skills with a focus on detailed work.
  • Excellent written and verbal communication skills
  • Solid organizational skills including attention to detail and multitasking skills
  • Strong working knowledge of Microsoft Office
  • Project Management Professional (PMP) / PRINCE II certification is a plus
  • Strong leadership skills.
  • Ability to initiate and manage multiple tasks in a fast-paced environment.
  • Ability to work as part of a team, meet deadlines & take instruction from multiple persons.
Volt is an equal opportunity employer.

Vacancy expired!

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