Quality Systems Specialist

Perform core regional quality systems activities as assigned (e.g., revising procedures; assisting in inspection readiness) following defined procedures.

Develop, improve, and revise regional quality system SOPs.

Conduct ongoing analysis and reporting of key quality and risk metrics and required actions.

Monitor and identify gaps within quality systems area and escalate for appropriate action.

Support project management for programs/ projects within quality systems area, and communicate with cross-functional teams within site/ area to drive quality outcomes.

• Bachelor’s degree, preferably in chemistry, biochemistry, or equivalent technical discipline with 3+ years of experience relevant to role (e.g. auditing and regulatory inspections; learning management systems/ training operations; document control processes; electronic quality systems).
• Experience in compliance with cGMPs and relevant health authority and Eisai regional guidelines.
• Experience in execution of quality processes within own quality systems area (e.g., SOP and protocol writing, metrics monitoring), and assisting in resolution of issues .
• Proven performance in earlier role.

• Works as a collaborative player and effectively seeks/ conveys understanding of diverse viewpoints.
• Communicates with colleagues across levels as needed and influences for the best outcomes.
• Presents information(written and verbal) in a clear, well thought out way and tailored to the audience.

Escalates issues/problems and seeks support in a timely manner