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SQ Manager

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Omrix Bio-pharmaceuticals is seeking a Manager, Quality Source

This position will provide Source Quality support in line with established J&J MD, industry and regulatory standards

The Manager, Quality Source will develop and monitor QA systems to ensure that all External Manufacturers as well as material and service provider meet their quality objectives with regards to supplier, process and product controls

The Manager, Quality Source will:

  • Be responsible for the overall quality activities, including purchasing controls, associated with external manufacturers
  • Lead development, continuous improvement and implementation of purchasing control processes for assigned supply base that meet regulatory requirements and align with J&J MD standards.
  • Ensure effective and timely investigation and closure of all CAPA’s, Non-Conformance, complaints, product issues.
  • Provide Source Quality Engineering support to external manufacturers including product non-conformance, verification/validation activities, CAPA and change management
  • Maintain supplier management documentation and records to ensure they are complete and current
  • Promote continuous improvement and Process Excellence activities within the Quality Source Management group
  • Work to ensure supplier quality engineering resources are prioritized in support of business and quality aims
  • Design and validate Quality System processes where appropriate
  • Resolve problems and eliminate constraints to ensure project and supply targets are met.
  • Generate Quality metrics on supplier performance and establish measures to monitor quality
  • Maintain standards of housekeeping and GMP requirements

 

Education and/or Experience

A minimum of a bachelor’s degree in engineering/scientific or associated relevant technical / engineering discipline is required.

An advanced degree in engineering/scientific or discipline is preferred.

A minimum of 6 years progressive experience in a regulated industry like Medical Devices, Pharma and/or Consumer is required.

Previous work experience within Source Quality is highly preferred.

Demonstrated knowledge of business impact of compliance issues and risk management is required.

Experience in leadership roles involving project management, problem solving, and technical projects is required.

This position is located in Israel and will require up to 30% travel, including some international.

 

Resume- is to be sent written in English.

אומריקס הינה חברה ביו-טכנולוגית המייצרת ומפתחת מוצרים מצילי חיים ב- 2 תחומים: ביוכירורגיה וחיסונים פאסיביים. החברה נוסדה ב 1995 ומתמחה בפיתוח וייצור של מוצרים ביוטכנולוגיים מתקדמים מפלסמה אנושית. אומריקס מועסקים מעל 500 עובדים בישראל, בשלושה אתרים מרכזיים: תל השומר, הר החוצבים ירושלים ונס ציונה.

הגעת לתפריט הנגישות, לחץ ENTER על מנת לדלג על התפריט.