GCP QA Auditor III/Principal QA Auditor - Home or Office Based

Submission for the position: GCP QA Auditor III/Principal QA Auditor - Home or Office Based - (Job Number: 172223)

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.  At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!   

Our colleagues in corporate strive for excellence in every task, at every moment. We are game changers seeking improvements to processes and more efficient ways of working or adapting to changing financial and industry environments.

As a QA Auditor III/Principal QA Auditor you will manage or QA Event system and lead directed audits .

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and well being of our employees.   

Summarized Purpose:

Identifies issues impacting the quality and/or integrity of clinical research programs, determines root cause of non-conformance and develops strategies to address issues. Provides guidance to operational departments as a subject matter expert (SME) for regulations, ICH GCP guidance, and PPD SOPs. Provides support to clients and internal teams for regulatory inspections of sponsors and investigative sites. May perform directed audits as part of the Quality Investigation and Support group and provide audit reports to management.

Essential Functions:     Leads directed site audits Provides GCP consultation and support to PPD project teams and external clients 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 Provides mentorship and guidance to junior auditors

#LI-JN1

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.  At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!   

Our colleagues in corporate strive for excellence in every task, at every moment. We are game changers seeking improvements to processes and more efficient ways of working or adapting to changing financial and industry environments.

As a QA Auditor III/Principal QA Auditor you will manage or QA Event system and lead directed audits .

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and well being of our employees.   

Summarized Purpose:

Identifies issues impacting the quality and/or integrity of clinical research programs, determines root cause of non-conformance and develops strategies to address issues. Provides guidance to operational departments as a subject matter expert (SME) for regulations, ICH GCP guidance, and PPD SOPs. Provides support to clients and internal teams for regulatory inspections of sponsors and investigative sites. May perform directed audits as part of the Quality Investigation and Support group and provide audit reports to management.

Essential Functions:     Leads directed site audits Provides GCP consultation and support to PPD project teams and external clients 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 Provides mentorship and guidance to junior auditors

#LI-JN1

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 5 years’) or equivalent combination of education, training, & experience. Successful completion of PPD Foundation Training.

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills and Abilities:     

Meets competencies for QA Auditor I 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 and critical thinking, 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 

Working Environment:  

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary for typical working hours.

Ability to use and learn standard office equipment and technology with proficiency .

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

May require travel, ~10%. (Recruiter will provide more details.)

PPD Defining Principles:  

We have a strong will to win - We earn our customer’s trust - We are game changers - We do the right thing - We are one PPD  

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.  

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 5 years’) or equivalent combination of education, training, & experience. Successful completion of PPD Foundation Training.

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills and Abilities:     

Meets competencies for QA Auditor I 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 and critical thinking, 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 

Working Environment:  

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary for typical working hours.

Ability to use and learn standard office equipment and technology with proficiency .

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

May require travel, ~10%. (Recruiter will provide more details.)

PPD Defining Principles:  

We have a strong will to win - We earn our customer’s trust - We are game changers - We do the right thing - We are one PPD  

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.   Submission for the position: GCP QA Auditor III/Principal QA Auditor - Home or Office Based - (Job Number: 172223)