Sr QA Specialist

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.

As a Sr. QA Specialist, you will provide comprehensive support within quality assurance to include the areas of quality/regulatory agreement review, coordination and leading of client audits, regulatory support as well as the liaison between the client, QA and laboratory.

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.

Summarized Purpose:

Provides comprehensive expertise to the department covering one or more specialized quality management areas, such as GxP manufacturing, quality systems investigations and audits, lab investigations, root cause analysis, or Total Quality Management (TQM), assuring all systems, processes and their outcomes comply with applicable international and national regulations and guidelines and fulfill client and company requirements, and may lead vendor and internal audits, participate in client and regulatory inspections, and/or manage the administration and reporting aspects of quality management systems. Serves as quality consultant to the organization in their area(s) of GxP expertise, acting as are source for training activities and policy-making decisions, supporting business leaders in mitigation of risk, and responsible to build relationships between on-site QA services and QA management of designated clients.

Essential Functions:

• Manages and leads all activities associated with client, regulatory, vendor, quality management system and/or internal audits and investigations to include: coordination, scheduling, hosting, conduction of audits and review of audit responses.

• Verifies compliance with SOPs/WPDs and contractual obligations for audit target selection and frequency of audits to ensure ongoing quality.

• Liaises with several internal departments and senior management to provide full internal oversight of the GxP/GDP services provided to clients and facilitate interaction across functional, regulatory and legal teams.

• Develops, updates and disseminates SOPs/WPDs as they relate to quality processes.

• Performs internal and external audit related activities as needed and escalates significant issues appropriately. Continually ensures audit readiness of client files.

• Contributes to quality process improvement activities to ensure the organization meets or exceeds client expectations for the implementation of quality management systems and processes.

• Ensures full compliance with internal procedures pertaining to quality investigations, quality audits and quality improvement initiatives.

• Provides mentorship and guidance to less experienced quality staff.

• Performs root cause analysis. Assists in resolving critical quality issues to include

CAPAs, complaints and recalls, and resolves non-critical quality issues such as deviations.

• Generates reports to provide internal management with tracking, trending, informed analysis reports, process improvement data and key performance metrics.

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.

As a Sr. QA Specialist, you will provide comprehensive support within quality assurance to include the areas of quality/regulatory agreement review, coordination and leading of client audits, regulatory support as well as the liaison between the client, QA and laboratory.

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.

Summarized Purpose:

Provides comprehensive expertise to the department covering one or more specialized quality management areas, such as GxP manufacturing, quality systems investigations and audits, lab investigations, root cause analysis, or Total Quality Management (TQM), assuring all systems, processes and their outcomes comply with applicable international and national regulations and guidelines and fulfill client and company requirements, and may lead vendor and internal audits, participate in client and regulatory inspections, and/or manage the administration and reporting aspects of quality management systems. Serves as quality consultant to the organization in their area(s) of GxP expertise, acting as are source for training activities and policy-making decisions, supporting business leaders in mitigation of risk, and responsible to build relationships between on-site QA services and QA management of designated clients.

Essential Functions:

• Manages and leads all activities associated with client, regulatory, vendor, quality management system and/or internal audits and investigations to include: coordination, scheduling, hosting, conduction of audits and review of audit responses.

• Verifies compliance with SOPs/WPDs and contractual obligations for audit target selection and frequency of audits to ensure ongoing quality.

• Liaises with several internal departments and senior management to provide full internal oversight of the GxP/GDP services provided to clients and facilitate interaction across functional, regulatory and legal teams.

• Develops, updates and disseminates SOPs/WPDs as they relate to quality processes.

• Performs internal and external audit related activities as needed and escalates significant issues appropriately. Continually ensures audit readiness of client files.

• Contributes to quality process improvement activities to ensure the organization meets or exceeds client expectations for the implementation of quality management systems and processes.

• Ensures full compliance with internal procedures pertaining to quality investigations, quality audits and quality improvement initiatives.

• Provides mentorship and guidance to less experienced quality staff.

• Performs root cause analysis. Assists in resolving critical quality issues to include

CAPAs, complaints and recalls, and resolves non-critical quality issues such as deviations.

• Generates reports to provide internal management with tracking, trending, informed analysis reports, process improvement data and key performance metrics.

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).

Knowledge, Skills and Abilities:

• Comprehensive expertise in all aspects of pharmaceutical GxP regulations (e.g. quality systems, root

cause analysis and Total Quality Management) including international regulations

• Knowledge of applicable parts of 21 CFR regulations

• May require knowledge of ISO standards where applicable

• Expertise in GxP and appropriate regional clinical research regulations and guidelines

• Proven proficiency with leading a range of project based or internal GxP audits and vendor audits to

high standards

• Superior oral and written communication skills

• Expert problem solving, risk assessment and impact analysis abilities

• In depth experience in root cause analysis

• Excellent negotiation and conflict management skills

• Ability to remain flexible, multitask, and prioritize competing demands

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.

Ableto work upright and stationary and/or standingfor 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 technologywith proficiency.

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

Knowledge, Skills and Abilities:

• Comprehensive expertise in all aspects of pharmaceutical GxP regulations (e.g. quality systems, root

cause analysis and Total Quality Management) including international regulations

• Knowledge of applicable parts of 21 CFR regulations

• May require knowledge of ISO standards where applicable

• Expertise in GxP and appropriate regional clinical research regulations and guidelines

• Proven proficiency with leading a range of project based or internal GxP audits and vendor audits to

high standards

• Superior oral and written communication skills

• Expert problem solving, risk assessment and impact analysis abilities

• In depth experience in root cause analysis

• Excellent negotiation and conflict management skills

• Ability to remain flexible, multitask, and prioritize competing demands

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.

Ableto work upright and stationary and/or standingfor 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 technologywith proficiency.

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.