Project Manager II - Foster City, CA | Biospace
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Project Manager II

I.T. Solutions, Inc.

Location:
Foster City, CA
Posted Date:
9/13/2017
Position Type:
Contract
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Manufacturing, Pharmaceutical, QA, Quality, Quality Assurance,

Job Description

Position:  Project Manager II
Biotech/Pharma
Location: Foster City, CA
Type: Contract on W2

6+ years of relevant experience and a BA or BS or a MS or MBA; and/or 8-10+ years of relevant experience working association with Quality in Pharmaceutical, Biotechnology, or Medical Device Industry; and/or 4+ years of experience working with project teams and/or in cross-functional project management activities.

Provide project management support Services for Quality Organization in Foster, City, CA that will include the following:
•   Work with the Quality Organization on Operational Excellence initiatives/projects.
•   Manage Organizational and/or Functional Quality Plan initiative to ensure continuous progress towards achieving goals and objectives through the completion of defined activities.
•   Manage team meeting scheduling, monitoring completion of action items, mitigation of identified risks and communication of roadblocks.
•   Manage coordination of collaboration between cross-functional resources for completion of selected Clinical Lot Release activities.
•   Ensure compliance with Regulatory Guidance documents and cGMP requirements.
•   Manage and communicate overall project status updated to the Project Management Office and Quality Leadership.
•   Coordinate and support company-wide forums chaired by Quality Leadership.
•   Build timelines, work breakdown structures, following up with staff on the completion of their tasks
•   Use PowerPoint, MS Project, or Excel to create concise presentations for Leadership on status of project
•   Act as voice of senior management for guidance of projects and initiatives at the direction of company.

Requirements

Requirements:
•   Must have a thorough understanding of computer systems validation in a biotech or pharma environment.
•   GxP, FDA EU/Canada requirement knowledge
•   Understand drug product commercial release process - clinical trial, lot release, etc.
•   Experience with deviation management, CAPA, GxP change control and audit
•   High energy, strategic thinker with strong communication skills.