$150K — $200K *
-This position has signatory responsibilities for all qualifications/validation issues associated with assigned area(s).
-The individual will participate in project teams and will review and approve qualification and validation related documentation for assigned areas including but not limited to Validation Plans, User Requirements, Specifications, FATs, SATs, IOQs, PQ and PV.
-Accountable for the qualification and validation of equipment and process, which includes the review and approval of documentation (Datapacks, Reports, Records, Procedures, and Commissioning) to ensure compliance to Global Quality Directives, industry standards (i.e GAMP, ICH, ANNEX), Code of Federal Regulations, and SANOFI site standards.
-Accountable to provide quality compliance leadership, within the realm of qualifications and validation, procedural changes.
-Accountable for ensuring the quality compliance of cGMP, FDA and EU regulatory agency and internal requirements regarding the manufacture, testing, and distribution of Sanofi products, through formal Quality audits, investigations, internal and external regulation inspections, training, and recommendations to procedures
-Bachelor’s Degree in the field of Science or Engineering.
-10 years experience in a GMP regulated environment working on qualification and validation projects associated with Pharmaceutical or biotech processes.
-Must have an understanding of vaccines/biologics products and associated technologies
-Excellent communication skills and teamwork are a must, as individual will be working with various areas throughout Industrial Operations and Regulatory Affairs. Good interpersonal and influencing skills are important for a candidate’s success in this role.
-Knowledge of current FDA regulations and industry guidance related to validation processes.
Valid through: 10/21/2020
$200K — $250K