Essential Functions:   

• Conducts and leads a variety of client, internal or GCP audits and process audits as requested by senior management
• Provides GCP consultation and support to PPD project teams and external clients Leads process audits and may participate as a co-auditor in more complex system audit.
• Performs other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement)
• Serves as a resource 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
• Act as a lead for client with billable audits
• Provides mentorship and guidance to junior auditors
• This role will have a travel requirement of up to 50%.

Education and Experience: 

• Bachelor’s degree or equivalent and relevant formal academic / vocational qualification
• Previous QA experience in GCP area that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience.
• Previous experience in other GxP areas welcomed.

Knowledge, Skills and Abilities:   

• Thorough knowledge of GCP and appropriate regional research regulations and guidelines
• Demonstrated proficiency and led a range of project based or internal GCP audits and vendor audits to high standards required by management
• Excellent oral and written communication skills
• Willingness to travel
• 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/workload
• Valid driver’s license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel