משרות תוצאות חיפוש מתאימות לבקשתך:

a global biotech company is looking for QA operations Leader
o Leads the quality operations activities across the site, ensuring appropriate staffing, skills and competencies are consistent with present and future needs, verifying that quality systems are in place to maintain the required compliance level across the site, and driving quality system (QS) execution while reducing risk of non-conforming product.
o Work closely with other departments to maintain compliance for the Omrix quality and PV systems.
o Supports E2E base business activities by providing quality engineering process requirement and technical support for complex manufacturing process and projects as required.
o Supports quality systems issues (CAPA’s, Non-Conformances and changes) related to Facility, systems, equipment, laboratory, existing processes and developments of new processes.
o Conducts and Participates in audits for good manufacturing practices, international organization for standardization and any other applicable standards.
o Drive people leadership agenda, seeking for team growth and development and driving high performance teams based on our Credo and the Leadership imperatives values
o Reports to quality director and a member of the quality management team.
o Member of site leadership team
o Works with external suppliers (mainly in the medical device filed)
o The scope of this position includes all related to both biologics and device.

דרישות:
o BS degree in Business, Life Science, Physical Science, Engineering or other related field required.
o Minimum of 8 years of experience in compliance or quality in a regulated (FDA) environment.
o Experience in the Pharmaceutiacal industry
o Experience in people management, including managing managers – a must
o Experience in biopharmaceutical manufacturing is required, experience with combination products is preferred.
o Experience in handling patient/customer complaints, inquiries or servicing issues preferred
o Experience interacting with FDA, EMA, IMOH and other regulatory agencies preferred
o Knowledge of regulations in relevant markets.
o Lead in a matrix organization
o Establish a diverse and inclusive work environment and culture