Project Manager, GxP Quality Assurance
W2 Contract
Pay Rate: $80 - $90 per hour
Location: Redwood City, CA - Hybrid Role
Duties and Responsibilities:
- Coordinate and lead cross-functional Quality projects, including QA process improvement and enhancement initiatives, to ensure alignment with business objectives and delivery against established timelines.
- Contribute to the planning and execution of strategic initiatives within the GxP Quality Assurance function to strengthen operational effectiveness and compliance.
- Coordinate and facilitate quality & cross-functional meetings, including agenda development, documentation of key decisions, and tracking action items through completion.
- Develop and maintain comprehensive project documentation, including project timelines, risk registers, action item trackers, dashboards, and status reports to ensure transparency and accountability.
- Identify project risks, gaps, and process inefficiencies, and proactively facilitate mitigation strategies to ensure compliance, operational continuity, and successful project outcomes.
- Coordinate inspection and commercial readiness activities from the Quality team to support organizational objectives, including global expansion.
Requirements and Qualifications:
- Strong project planning, scheduling, and resource management skills.
- Excellent communication and presentation skills, with the ability to present to senior leadership.
- Strong stakeholder engagement and alignment skills.
- Experience with developing clear, visually compelling PowerPoint presentations with strong narrative flow and impactful visuals.
- Experience working in Pharmaceutical, biotech companies, and partnering with key stakeholders, including Regulatory, Clinical, CMC, Manufacturing, and IT.
- Knowledge of Quality Assurance principles within the pharmaceutical/biotech industry, including GxP regulations and QMS processes
Preferred Qualifications:
- Strong analytical skills with the ability to interpret quality metrics and identify trends and risks.
- Strong leadership, problem-solving, and organizational skills.
- Ability to work effectively in a fast-paced, cross-functional, and regulated environment.
Desired Skills and Experience
Project Management, GxP Quality Assurance, Quality Management Systems (QMS), GxP Compliance, Pharmaceutical Quality Systems, Biotech Quality Assurance, Cross-Functional Project Leadership, Quality Process Improvement, Strategic Initiative Execution, Risk Management & Mitigation, Quality Metrics Analysis, Inspection Readiness, Commercial Readiness, Stakeholder Management, Regulatory & Clinical Collaboration, CMC Collaboration, Manufacturing Quality Coordination, IT Collaboration in Regulated Environments, Project Planning & Scheduling, Resource Management, Quality Documentation Management, Project Timelines & Roadmaps, Risk Registers, Action Item Tracking, Project Dashboards, Status Reporting, Meeting Facilitation, Agenda Development, Decision Documentation, Process Optimization, Operational Excellence, Compliance Oversight, PowerPoint Presentation Development, Executive Communication, Data Interpretation & Trend Analysis, Problem Solving, Leadership in Regulated Environments
Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as Inc.'s candidate.
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