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
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.
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.
- 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
- 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
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic /
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
- 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
Able to work upright and stationary for typical working
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!