Project Manager GxP Quality Assurance

Strong knowledge of Quality Assurance principles within the pharmaceutical/biotech industry, including GxP regulations and QMS processes.The Opportunity: Project Manager GxP Quality AssuranceCoordinate 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.Required Skills, Experience and Education:Strong project planning, scheduling, and resource management skills.Excellent communication and presentation skills, with 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 processesPreferred Skills:Strong analytical skills with 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.