Required VP QA/QC.
To promote overall quality goals and achievements across the company and educate on QA and QC principles.
To develop, establish, implement and maintain the QA/QC management systems.
To oversee development and implementation of standards, methods and procedures for evaluating the precision, accuracy, efficacy and reliability of critical processes.
To follow in-house GMP manufacturing and managing all related QC/QA activities.
To lay down procedures for the preparation, approval, authorization, control and revision of SOPs.
To review and edit company SOPs.
To assure appropriate documentation per product stage.
To audit all critical IND-enabling studies and reports.
Requirements:
Bachelor's Degree or higher within the Life Sciences space.
5+ years of experience within a quality role in a biologics focused environment.
Experience in establishing stage specific quality systems for R&D research, pre-clinical and clinical stages.
Experience in GMP manufacturing activities as review of batch records, OOS, CAPA, etc.
Experience in execution of analytical methods qualification and GMP stability studies.
Broad knowledge of drug development.
Expertise in GMP; strong working knowledge of FDA & EU and ICH regulations in relation to the manufacturing of biologics.
Participation in preparation of applications to regulatory authorities.
Attention to detail.
Excellent written English skills.