Associate Manager QA

PPD’s mission is toimprove health . It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside ourtalented, bright and energetic teams .

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 anAssociate Manager, Quality Assurance, you will lead a team in delivering quality assurance, risk management, compliance, and laboratory QA services.

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 Associate QA Manager assures internal and client processes and projects are compliant and inspectionready, manages and develops staff.They ensure delivery of quality solutions in a collaborative cross-functionalenvironment.

Essential Functions: Manages the day-to-day operations of a QA team and provides oversight, development and performance management to staff Assesses priority of projects and monitors work assignments ensuring adequate resourcing to meet client project timelines and provides quality deliverables Assists senior management in the evaluation of QA programs to help maintain regulatory compliance and efficiency of QA audits Evaluates audit and inspection findings produced by QA staff and determines appropriate departmental interpretation. Identifies issues that may require follow-up inspection. Reports findings to staff and senior management Participates in client and regulatory inspections in order to provide information regarding the QA program and facilitates responses

Policy & Strategy: Administers and executes policies, processes, and procedures that affect subordinate employees and the workflow of the unit. Requires full knowledge of own area of functional responsibility. Freedom to Act Assignments are task or activity oriented. Work is reviewed for soundness of judgment and overall quality and efficiency. A portion of the time may be spent performing individual tasks. Liaison Interacts internally primarily with subordinates and other supervisors. External interaction is typically with suppliers, vendors, and / or primary customers. Primary purpose of liaison is information sharing and basic problem resolution.

#GD

PPDLABS PPD’s mission is toimprove health . It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside ourtalented, bright and energetic teams .

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 anAssociate Manager, Quality Assurance, you will lead a team in delivering quality assurance, risk management, compliance, and laboratory QA services.

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 Associate QA Manager assures internal and client processes and projects are compliant and inspectionready, manages and develops staff.They ensure delivery of quality solutions in a collaborative cross-functionalenvironment.

Essential Functions: Manages the day-to-day operations of a QA team and provides oversight, development and performance management to staff Assesses priority of projects and monitors work assignments ensuring adequate resourcing to meet client project timelines and provides quality deliverables Assists senior management in the evaluation of QA programs to help maintain regulatory compliance and efficiency of QA audits Evaluates audit and inspection findings produced by QA staff and determines appropriate departmental interpretation. Identifies issues that may require follow-up inspection. Reports findings to staff and senior management Participates in client and regulatory inspections in order to provide information regarding the QA program and facilitates responses

Policy & Strategy: Administers and executes policies, processes, and procedures that affect subordinate employees and the workflow of the unit. Requires full knowledge of own area of functional responsibility. Freedom to Act Assignments are task or activity oriented. Work is reviewed for soundness of judgment and overall quality and efficiency. A portion of the time may be spent performing individual tasks. Liaison Interacts internally primarily with subordinates and other supervisors. External interaction is typically with suppliers, vendors, and / or primary customers. Primary purpose of liaison is information sharing and basic problem resolution.

#GD

PPDLABS

Qualifications:

Education and Experience: Bachelor’s degree in science (Biology or Forensic Science preferred) Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years) or equivalent and relevant combination of education, training, & experience. 1 year of leadership responsibility

Knowledge, Skills and Abilities: Knowledge of FDA guidelines and applicable global vaccineindustry guidelines Knowledge of analytical methodologies, instrumentation and method validation required for Lab QAManagement Good verbal and written communication skills Demonstrated proficiency with regulations and guideline interpretation, audit procedures, proper documentation and QA departmental policies and procedures Detail oriented with ability to deal with multiple and changing priorities Solid leadership and time management skills

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, including infectious agents, 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.

Qualifications:

Education and Experience: Bachelor’s degree in science (Biology or Forensic Science preferred) Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years) or equivalent and relevant combination of education, training, & experience. 1 year of leadership responsibility

Knowledge, Skills and Abilities: Knowledge of FDA guidelines and applicable global vaccineindustry guidelines Knowledge of analytical methodologies, instrumentation and method validation required for Lab QAManagement Good verbal and written communication skills Demonstrated proficiency with regulations and guideline interpretation, audit procedures, proper documentation and QA departmental policies and procedures Detail oriented with ability to deal with multiple and changing priorities Solid leadership and time management skills

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, including infectious agents, 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.