Principal Validation Analyst - Data Integrity Specialist

Submission for the position: Principal Validation Analyst - Data Integrity Specialist - (Job Number: 186417)

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.

Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD® Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success.

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 wellbeing of our employees.

The IT Team at PPD’s GMP Laboratory has an opening for a Principle Validation Analyst focused on Data Integrity. This is a great opportunity to become part of a dynamic, rapidly growing business.

The Data Integrity Specialist will ensure our ongoing compliance with regulatory and industry expectations around Data Integrity. Specific responsibilities will include: Develops and maintains the GMP Laboratory strategy for Data Integrity. Evaluates proposed and existing software applications for Data Integrity compliance. Performs Data Integrity risk assessments of laboratory systems. Prioritizes risks and leads cross-functional Data Integrity initiatives involving IT, QA, and Laboratory personnel. Maintains currency with U.S. and European regulations related to Data Integrity. Prepares, maintains, and delivers presentation materials to client auditors and regulators for Data Integrity subject matter. Represents PPD in client and regulatory audits related to Data Integrity. Facilitates the completion of client questionnaires related to Data Integrity. Establishes a firm understanding of PPD IT Infrastructure, assesses proposed changes for Data Integrity implications, and recommends infrastructure changes to enhance Data Integrity.

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.

Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD® Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success.

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 wellbeing of our employees.

The IT Team at PPD’s GMP Laboratory has an opening for a Principle Validation Analyst focused on Data Integrity. This is a great opportunity to become part of a dynamic, rapidly growing business.

The Data Integrity Specialist will ensure our ongoing compliance with regulatory and industry expectations around Data Integrity. Specific responsibilities will include: Develops and maintains the GMP Laboratory strategy for Data Integrity. Evaluates proposed and existing software applications for Data Integrity compliance. Performs Data Integrity risk assessments of laboratory systems. Prioritizes risks and leads cross-functional Data Integrity initiatives involving IT, QA, and Laboratory personnel. Maintains currency with U.S. and European regulations related to Data Integrity. Prepares, maintains, and delivers presentation materials to client auditors and regulators for Data Integrity subject matter. Represents PPD in client and regulatory audits related to Data Integrity. Facilitates the completion of client questionnaires related to Data Integrity. Establishes a firm understanding of PPD IT Infrastructure, assesses proposed changes for Data Integrity implications, and recommends infrastructure changes to enhance Data Integrity.

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8 years).

Knowledge, Skills and Abilities: 5 years working in a GMP regulated pharmaceutical environment. 3 years of experience working with Information Technology and a fundamental understanding of IT concepts. 3 years of experience in a computer systems validation or related quality assurance role. Working knowledge of applicable GMP regulations, particularly 21 CFR Part 11, Eudralex Volume 4 Annex 11, and current FDA/MHRA guidance on data integrity. Ability to communicate effectively with all levels of the organization. Proficiency in Microsoft Office (Word, Excel, PowerPoint).

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 and/or standing for typical working hours

Able to lift and move objects up to 25 pounds

Able to work in non-traditional work environments

Able to use and learn standard office equipment and technology with proficiency

May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments

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

PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - 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 experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8 years).

Knowledge, Skills and Abilities: 5 years working in a GMP regulated pharmaceutical environment. 3 years of experience working with Information Technology and a fundamental understanding of IT concepts. 3 years of experience in a computer systems validation or related quality assurance role. Working knowledge of applicable GMP regulations, particularly 21 CFR Part 11, Eudralex Volume 4 Annex 11, and current FDA/MHRA guidance on data integrity. Ability to communicate effectively with all levels of the organization. Proficiency in Microsoft Office (Word, Excel, PowerPoint).

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 and/or standing for typical working hours

Able to lift and move objects up to 25 pounds

Able to work in non-traditional work environments

Able to use and learn standard office equipment and technology with proficiency

May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments

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

PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - 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: Principal Validation Analyst - Data Integrity Specialist - (Job Number: 186417)