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 Assurance

• 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.

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 processes

Preferred 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.