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.

Essential Functions and Other Job Information:

 Conducts and/or leads a variety of client, internal or GxP audits and regulatory

inspections as requested by senior management

 Leads directed site audits, facility, vendor and/or sub-contractor audits

 Provides GxP consultation and support to PPD project teams and external clients

 Leads process audits and may participate as a co-auditor in more complex

system audits

 Performs other types of QA audits or activities (e.g. database audits, clinical

study report audits, sample results tables, process improvement)

 Serves as a resources to operational departments on audit or quality assurance

subject matter

 Prepares and presents audit findings and/or other related information at

departmental, internal operations or client meetings

 Provides mentorship and guidance to junior auditors

Qualifications:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable

to 5+ years’) or equivalent combination of education, training, & experience. Successful completion of

PPD Foundation Training.

Knowledge, Skills and Abilities:

 Meets competencies for QA Auditor II plus:

 Thorough knowledge of GxP and appropriate regional research regulations and guidelines

 Demonstrated proficiency and led a range of project based or internal GxP audits and vendor audits

to high standards required by management

 Excellent oral and written communication skills

 Strong problem solving, risk assessment and impact analysis abilities

 Solid experience in root cause analysis

 Above average negotiation and conflict management skills

 Flexible and able to multi-task and prioritize competing demands/work load

 Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient

credit line for business travel