QA Manager, FPPF- for internal move ONLY
Omrix Biopharmaceuticals is seeking a QA Manager, FPPF for internal move ONLY.
Reports to: Quality Director
Location: the position is in the Omrix Nes-Tziona site.
•Establishes and maintains quality assurance programs, procedures, and controls. Ensures that performance and quality of products conform to established company and regulatory standards.
•Reporting to quality director and a member of the quality management team.
•Responsibilities over quality issues at all departments (including but not limited to Production, packaging, supply chain, QC Laboratory).
•Responsibilities over all QA release activities.
•Member of the site leadership team.
•BSC. degree, Life Science, Physical Science, Engineering or other related field required.
•Minimum of 4 years of experience in compliance or quality in a regulated (FDA) environment.
•Experience in people management – preferred
•Experience in biopharmaceutical manufacturing is required, experience with combination products is preferred.
•Experience in handling patient/customer complaints, inquiries or servicing issues preferred
•Experience interacting with FDA, EMA and other regulatory agencies preferred
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS.
•Experience or proven record motivating leading and developing staff, in a highly changing environment.
•Demonstrating fortitude to make Quality calls.
•Working through multiple set-backs and unforeseen challenges.
•Six Sigma, Quality Engineer or Quality Auditor Certifications are preferred.
Location: נס ציונה