The Associate Manager, Corporate Quality Assurance - Auditing is responsible for executing GxP Quality Assurance (QA) auditing functions with an emphasis on Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) quality systems that govern compliance programs for PTC commercial and clinical activities. The incumbent supports and/or conducts internal and external GMP and GDP compliance audits of Contract Manufacturing Organizations (CMOs), vendors, laboratories, submission documents, etc. The Associate Manager works cross-functionally with internal departments and external resources on GMP/GDP QA related issues and may assume additional responsibilities, as required.
The Associate Manager, Corporate Quality Assurance - Auditing supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
*Special knowledge or skills and/or licenses or certificates preferred.