Quality Assurance Auditor II/III/Compliance Manager - GCP Government Consulting - Home or Office Based

Submission for the position: Quality Assurance Auditor II/III/Compliance Manager - GCP Government Consulting - Home or Office Based - (Job Number: 183709)Quality Assurance Auditor II/III/Compliance Manager - GCP Government Consulting - Home or Office Based Quality Assurance Auditor II/III/Compliance Manager - GCP Government Consulting - Home or Office Based

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining atruly collaborative and winning cultureas we strive to bend the time and cost curve of delivering life-saving therapies to patients.  

Our colleagues in PPD Government and Public Health Service 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/Compliance Manager, you will c onduct complex internal and external audits and pre/mock inspections to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and client contractual obligations.

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:

Conducts complex internal and/or external audits and pre/mock inspections toensure compliance with establishedprocesses, standards, global regulatory guidelines and/or client contractual obligations. Identifies issues impacting the quality and/or integrity of clinical research programs, determines rootcause ofnon-conformance and develops strategies to address issues. May perform technical document review and other GCP/GxP practice activities in support of clinical development programs. Provides auditreports 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:     Conducts and/or leads a variety of client or internal GCP/GxP audits/activities and host regulatory inspections as requested by senior management Performs routine/directed site audits, facility, vendor and/or sub-contractor audits Provides GCP/GxP consultation and support to PPD project teams and external clients Leads process audits and may participate as a co-auditor in more complexsystem audits Performs other types of QA audits or activities (e.g. database audits, clinicalstudy report audits, sample results tables, process improvement) Serves as a resources to operational departments on audit or quality assurancesubject matter Prepares and presents audit findings and/or other related information atdepartmental, internal operations or client meetings Experience with FDA regulations and ICH E6 guideline, US Government (NIH, DAIDS, BARDA, ARMY) GCP experience desirable.

#LI-JN1

#LI-Remote

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining atruly collaborative and winning cultureas we strive to bend the time and cost curve of delivering life-saving therapies to patients.  

Our colleagues in PPD Government and Public Health Service 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/Compliance Manager, you will c onduct complex internal and external audits and pre/mock inspections to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and client contractual obligations.

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:

Conducts complex internal and/or external audits and pre/mock inspections toensure compliance with establishedprocesses, standards, global regulatory guidelines and/or client contractual obligations. Identifies issues impacting the quality and/or integrity of clinical research programs, determines rootcause ofnon-conformance and develops strategies to address issues. May perform technical document review and other GCP/GxP practice activities in support of clinical development programs. Provides auditreports 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:     Conducts and/or leads a variety of client or internal GCP/GxP audits/activities and host regulatory inspections as requested by senior management Performs routine/directed site audits, facility, vendor and/or sub-contractor audits Provides GCP/GxP consultation and support to PPD project teams and external clients Leads process audits and may participate as a co-auditor in more complexsystem audits Performs other types of QA audits or activities (e.g. database audits, clinicalstudy report audits, sample results tables, process improvement) Serves as a resources to operational departments on audit or quality assurancesubject matter Prepares and presents audit findings and/or other related information atdepartmental, internal operations or client meetings Experience with FDA regulations and ICH E6 guideline, US Government (NIH, DAIDS, BARDA, ARMY) GCP experience desirable.

#LI-JN1

#LI-Remote

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 2 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 GCP/GxP and appropriate regional research regulations and guidelines

Demonstrated proficiency and led a range of project based orinternal GCP/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 sufficientcredit 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 ideaswith diverse groups of peoplein a comprehensible and reasonable manner.

Able to work upright and stationary for typical working hours.

Ability to use and learnstandard office equipment andtechnologywith proficiency.

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

When we can return to traveling safely this position is targeted to travel every other week in the US, there may be some travel to Latin America and or Africa is needed. During the pandemic depends on where you can travel safely.

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 2 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 GCP/GxP and appropriate regional research regulations and guidelines

Demonstrated proficiency and led a range of project based orinternal GCP/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 sufficientcredit 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 ideaswith diverse groups of peoplein a comprehensible and reasonable manner.

Able to work upright and stationary for typical working hours.

Ability to use and learnstandard office equipment andtechnologywith proficiency.

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

When we can return to traveling safely this position is targeted to travel every other week in the US, there may be some travel to Latin America and or Africa is needed. During the pandemic depends on where you can travel safely.

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: Quality Assurance Auditor II/III/Compliance Manager - GCP Government Consulting - Home or Office Based - (Job Number: 183709)Quality Assurance Auditor II/III/Compliance Manager - GCP Government Consulting - Home or Office Based