QC Manager

Job Responsibilities
• Lead, coach an******** the Quality Control Laboratory team, reviewcolleagues’ performance, an******** an******** object******** pr********metr******** development plans an******** performance assessments.
• Lea******** manage the laboratory testing for Analytical Chem********B******** Viral & Safety, Technical Serv******** an********Technical staff.
• Align with corporate Quality processes an******** systems such asproduct test******** CAPA, lab ******** stability test******** LIMS, labequipment calibration providing support to QC Systems.
• Take a lea******** in providing guidance an******** on failureinvestigations an******** of OOS investigations ensuring staffdevelopment in this area.
• Ensure that documentation an******** processes are in a constant stateof regulatory compliance an******** readiness
• Author/Contribute to CMC sections of Annual Progress Reportsan******** Product Reviews
• Manage performance an******** of direct reports providing regularlyschedule******** throughout the year to ensure achievement oforganizational an******** goals an******** productive environment.
• Proactively use scientific literature an******** to solve problems.
• Ensure test methods are qualified/validate******** support productionof products for clinical or commercial use.
• Identify an******** with outside manufacturers an******** test labs.
• Provide complete data analysis an******** able to drive projects tocompletion using data generate******** the design of new experimentsand/or critical assessment.
• May contribute to sections of regulatory submissions (primarily IND,BLA etc.).
• Ability to recogn******** trouble-shoot, an******** problems withequipment or individual assays.
Job Requiremen********
• Bachelor’s degree with 8+ years’ experience in Biotechnology industryin which 4+ years in quality managerial pos******** Master’s degree with6+ years’ experience. Or PhD with 4+ years’ experience in biotechnologyinduction in which 4+ years’ in quality managerial position.
• Thorough knowledge of GMP regulations an********.
• Ability to train others in the application of GMP. Ability to managemulti-disciplinary teams.
• Ability to make contributions across ******** an******** effectivelyinteract across departments in pursuit of company goals.
• Excellent verbal an******** communication skills; able to communicatein English
• Working knowledge of GMP as it relates to Biologics.
• Experience in directing an******** successful quality controllaboratory functions to achieve regulatory approval