QA Manager

Job Description:

Jerusalem Plant QA manager will manage the QA department in Operational & Project mode in Jerusalem. The department includes 5 team (process validation, equipment validation, drug substance, project quality, QA oversight of QC labs and directly manage 10 to 15 QA employees.

The department is growing and is suppose to double its size. The manager will also manage Israeli and oversea contactors and will report to VP Quality and dotted to Jerusalem Plant manager (member of the plant management board)..

Areas of Responsibilities:

Ensure conformance with all applicable GMP regulations.

Responsible for deviations, CAPA’S and change control.

Approval of validation protocols & validation reports.

Approval of engineering specifications & drawings.

Authority to release or reject the product upon review of all aspects.

Involvement in EHS (Environmental, Health, Safety) aspects.

Skills:

B.S.C/ M.S.C in Biology, Chemistry or related science.

+10 years of biotech/ Pharma experience in the Quality environment within a licensed or certified manufacturing site

Proven management experience of a large group of people (minimum 10 employees).

Prior experience with GMP/ISO Compliance/Auditing and document review.

Strong communications (written and verbal), analytical and technical writing skills.

Proven ability to manage conflicting forces and capability to drive data driven/ systematic oriented resolutions.

English- High level.