Program Manager - Quality Projects

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.

• 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.