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Compliance Specialist/Sr. Compliance Specialist - GCP - Home Based

Company: PPD
Location: Wilmington
Posted on: June 12, 2021

Job Description:

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 a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

Our colleagues in corporate 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 Compliance Specialist/Senior Compliance Specialist you will support and execute compliance strategies and initiatives across PPD, including facilitation of GCP client audits in respective PPD office(s).

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:

Supports and executes compliance strategies and initiatives across PPD, including facilitation of GCP client audits in respective PPD office(s). This includes qualification audits of PPD as well as project-specific audits for Phase II-IV services. Works with PPD project teams and functional departments to coordinate audit activities throughout the audit process (preparation, conduct, conduct, response and follow-up). Interacts with Client Auditors and PPD representatives throughout the audit process. Works independently with minimal supervision or mentoring required. Maintains client audit tools and materials and provides any other support or knowledge necessary to advance the vision of the Global Quality and Compliance (GQ&C) department.

Essential Functions:

  • Researches issues, tracks metrics, and maintains reports and documentation related to quality and compliance activities.
  • Administers quality and compliance processes and ensures appropriate execution and completion.
  • Contributes to projects and process/quality improvement initiatives.
  • Communicates with representatives from other departments to ensure quality and timelines are maintained with respect to compliance activities (e.g., client audits, CAPA and/or procedural documents).



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 2 years).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

  • Excellent oral and written communication skills
  • Solid organizational and time-management skills
  • Firm knowledge of the clinical trial process
  • Thorough knowledge and understanding of ICH GCP and other relevant regulations and guidelines
  • Effective problem solving skills
  • Strong attention to detail
  • Ability to work independently as required
  • Strong computer skills; ability to learn and become proficient with appropriate software
  • Ability to multitask and prioritize competing demands/work load
  • Demonstrated flexibility and adaptability

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 for typical working hours.

Ability to use and learn standard office equipment and technology with proficiency.

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

May require travel, ~10% typically within NC.

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!

Keywords: PPD, Wilmington , Compliance Specialist/Sr. Compliance Specialist - GCP - Home Based, Other , Wilmington, North Carolina

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