PPD Principal QA Auditor in Austin, Texas
Title: Principal QA Auditor Location: Texas-Austin - Metro Center 200
Conducts complex internal and 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. Performs technical document review and other GxP practice activities in support of clinical development programs. Provides audit reports to management. Serves in a lead capacity providing mentorship and guidance to junior auditors. Facilitates client audits, regulatory authority inspections or investigative site audits.
Essential Functions and Other Job Information:
Leads a variety of client, internal or GxP audits and regulatory inspections
Leads site audits, complex process and/or internal systems audits, facility, vendor and/or sub-contractor audits
Provides GxP consultation and support to PPD project teams and external clients
Performs other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement)
Serves as resource to operational departments on audit or quality assurance subject matter
Identifies issues impacting the quality and/or integrity of clinical research
programs, determines root cause of non-conformance and develops strategies to address issues
Prepares and presents audit findings and/or other related information at departmental, internal operations or client meetings
Provides mentorship and guidance to junior auditors
Participates in process improvement initiatives and performs other duties as assigned
Manages departmental projects as assigned
May supervise 1-2 direct reports
Education and Experience:
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 8 years’) or equivalent combination of education, training, & experience. successful completion of PPD Foundation Training.
Knowledge, Skills and Abilities:
Meets competencies QA Auditor III plus:
Expertise in GxP and appropriate regional clinical research regulations and guidelines
Excellent training/mentoring experience of junior auditors on a variety of co -audit types
Solid experience with a wide range of GxP audits (e.g. routine, directed, vendor, internal, database, client audits, complex process and systems audits)
Excellent oral and written communication skills
Well developed problem solving, risk assessment and impact analysis abilities
Extensive experience in root cause analysis
Strong 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
Limited management responsibility
Working Conditions and Environment:
Work is performed in an office/ laboratory and/or a clinical environment.
Exposure to biological fluids with potential exposure to infectious organisms.
Exposure to electrical office equipment.
Personal protective equipment required such as protective eyewear, garments and gloves.
Ability to work in an upright and /or stationary position for 6-8 hours per day.
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
Frequent mobility required.
Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
Frequently interacts with others to obtain or relate information to diverse groups.
Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi -task.
Regular and consistent attendance.
Pharmaceutical 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.