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
Apply via :
jobs.thermofisher.com
