QA Auditor II

Conducts complex internal and/or external audits and inspections to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. Identifies issues impacting the quality and/or integrity of clinical research programs, determines root cause of non-conformance and develops strategies to address issues.

May perform technical document review and other GxP practice activities in support of clinical development programs. Provides audit reports to management. Plans and delivers quality services for contracted quality assurance audits, internal site audits, laboratory and file audits for clients and projects.Conducts complex internal and/or external audits and inspections to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. Identifies issues impacting the quality and/or integrity of clinical research programs, determines root cause of non-conformance and develops strategies to address issues.

May perform technical document review and other GxP practice activities in support of clinical development programs. Provides audit reports to management. Plans and delivers quality services for contracted quality assurance audits, internal site audits, laboratory and file audits for clients and projects.Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualificationKnowledge, Skills and Abilities: Meets competencies for QA Auditor I plus:Thorough knowledge of GxP and appropriate regional research regulations and guidelinesDemonstrated proficiency and led a range of project based or internal GxP audits and vendor audits to high standards required by managementExcellent oral and written communication skills (English and Mandarin)Strong problem solving, risk assessment and impact analysis abilitiesSolid experience in root cause analysisAbove average negotiation and conflict management skillsFlexible and able to multi-task and prioritize competing demands/work loadValid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travelPharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualificationKnowledge, Skills and Abilities: Meets competencies for QA Auditor I plus:Thorough knowledge of GxP and appropriate regional research regulations and guidelinesDemonstrated proficiency and led a range of project based or internal GxP audits and vendor audits to high standards required by managementExcellent oral and written communication skills (English and Mandarin)Strong problem solving, risk assessment and impact analysis abilitiesSolid experience in root cause analysisAbove average negotiation and conflict management skillsFlexible and able to multi-task and prioritize competing demands/work loadValid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travelPharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.