VP QA
LTS is a leading pharmaceutical technology company that develops and manufactures innovative drug delivery systems for the pharmaceutical industry.
LTS´ commercial offering encompasses more than 20 marketed products.
LTS operates today from 5 sites: Netanya (Israel), Adrenarche (Germany), West Caldwell (NJ, USA), St. Paul (MN, USA), and Shanghai (China).
We are looking for an excellent VP QA to join our team in Israel.
The position is permanent, full time, hybrid.
עיקרי התפקיד
Part pf company’s Staff, reporting to GM.
Manage QA’s short term and long term planning and activity
Responsible for managing quality systems, processes, and procedures to assure product quality and safety.
Management representative for the company’s QMS
Overview, follow up and guidance of routine QA/QC activities such as CAPA, NCMRs, ECO, SCAR (customer compliant), incoming inspection, in process inspection, final inspection, product release.
Provide guidance to product development teams as to the required deliverables to ensure compliance throughout product development cycle.
Responsible for engaging strong intradepartmental and cross-functional/organizational relationships to drive quality system requirements.
Communication with regulatory and certification agencies
Responsible for Internal audits and suppliers' audits, certify suppliers to required standards. Lead external audit preparation
Direct Manager: GM
דרישות
Job skills: At least 10 years of work experience in the QA field
At least 5 years experience as a manager
QA management experience in a medical device company – a must
Solid experience in ISO and external Audits
Experience in working with medical device standards
Computer skills: Full control of all MS-Office applications
Language skills: English (reading, writing, and speaking) at a high level - mandatory.
Personality:
At LTS, we value collaboration, innovation, and accountability.
We're looking for individuals who can:
ü Teamwork: Collaborate effectively, embracing diverse perspectives.
ü Customer Focus: Exceed internal and external customer needs.
ü Innovation: Create new opportunities with enthusiasm.
ü Accountability: Take ownership of challenges, uphold standards.
ü Leadership: Motivate and develop talents,
יתרון
Education: A degree in science / Engineering – an
Experience in working with manufacturing companies – an
Clean room and sterilization understanding –a n
Experience in combination device field and working with Pharma companies - an