Focus on Quality

Gail Lynn, Quality Assurance

Gail Lynn is a senior quality systems analyst at PPD. She began working for PPD as an associate biostatistician in October 2005 for the biostatistics and programming department, having just graduated from university. Gail transitioned across to the quality systems group in September 2015.

Interviewer: Could you provide a brief overview of the quality systems department?

Gail: Quality systems is a group within the biostatistics and programming department to assist in maintaining the focus on quality. We are continuously striving to improve processes, as this is critical to maintaining our leadership in the marketplace. Quality systems are responsible for compliance and audits, Corrective and Preventive Actions (CAPAs) and metrics.

Interviewer: What are your responsibilities within quality services as a senior quality systems analyst?

Gail: I have responsibility for the CAPA process and disseminating lessons learned globally, as well as ensuring that the preventive actions are implemented and effective.

I generate key quality and performance indicators from project metadata for executive quality review quarterly.

I also compile and maintain an integrated database based on the project metadata. I write SAS programs to obtain metrics from this integrated database to assist management with responding to business development queries.

I’m jointly responsible for resourcing all randomizations that require input from the randomization team. I also support randomization as a randomization quality validator, reviewing randomization specification and authorization forms (RSAFs), surrogate and actual schedules.

Finally, I work with the training team to identify training needs that have arisen from CAPAs in order that they can implement this.

Interviewer: Where are you and the quality systems group located?

Gail: The quality systems team is made up of six people. I am home-based in the UK. The majority of the team is based in PPD’s world headquarters in Wilmington, North Carolina.

Interviewer: What does a typical day look like for you?

Gail: Although things change from day-to-day, a typical one begins with reviewing emails that have come in overnight. I will take action on any that I’m directly involved in that need reviewing or responding to in some way. I look for any new requests for randomizations and respond to the team either requesting further information or to say that I’m in the process of allocating a team.

I review any new CAPAs that have arisen and follow up with project teams, as well as following up on existing ones that are outstanding.

I respond to any requests for information that come in from business development. I work with project teams to update project metadata before running reports.

Interviewer: How has your career developed since joining PPD?

Gail: I joined PPD in October 2005 as an associate biostatistician, having just graduated from university. I worked my way up to senior biostatistician II and was looking to change my career direction. After contacting the quality systems team to express an interest, I began doing some ad-hoc work for them, in addition to my project lead role. The more I became involved, the more interesting I found it. When a vacancy arose I was quick to apply.

Interviewer: What do you enjoy the most about being a senior quality systems analyst?

Gail: I like many things about the role. I like the fact that no two days are the same. Each CAPA I get involved in is different, as are the business development requests. I also like being able to continue using my programming skills.

Interviewer: Why do you enjoy working for PPD?

Gail: I have been with PPD for many years and that is mainly due to the people and the values of PPD. I have always been made to feel that my contribution is valuable and that I’m an important member of the team. If I have any concerns, I am able to turn to my manager to discuss them openly and honestly. My supervisors go the extra mile to support and encourage me.

Interviewer: Finally, what advice would you give to someone interested in being a quality systems analyst at PPD?

Gail: I hope this interview has given you an idea of just some of the tasks the quality systems group work on, so if you’re interested in joining us then just go for it and do not be afraid to express an interest.

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