Senior Compliance Specialist

Bellshill, United Kingdom
11 Jul 2019
10 Aug 2019
Quality, QA / QC
Full Time
Contract Type
Experience Level
Experienced (non-manager)
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 48 countries and more than 21,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development and optimize value in delivering life-changing therapies to improve health.

We'd like to present you with a new career opportunity in our Quality Assurance department for the position of:

Senior Compliance Specialist

Supports and executes Compliance strategies and initiatives across PPD. Hosts client audits in respective PPD office(s); ensures all audit findings are responded to and appropriately followed up; tracks client audits and findings, and maintains relevant audit documentation. Participates in collection and review of audit responses from client audits of PPD Supports the facilitation and coordination of GCP regulatory authority inspections of PPD Phase II-IV studies conducted at PPD facilities.

Works independently with minimal supervision or mentoring required. Maintains Compliance tools and materials and provides any other support or knowledge necessary to advance the vision of the Global Quality and Compliance (GQ&C) department.


Education and Experience:

- Bachelor's degree in a scientific or related discipline

- 4+ years of clinical drug development experience including

- 2+ years clinical operations or quality management experience in the pharmaceutical industry and/or CRO

- Or equivalent combination of education, training and experience that provides the individual with the required knowledge, skills and abilities

Knowledge, Skills and Abilities:

- Excellent oral and written communication skills

- Solid organizational and time-management skills

- Extensive 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

- Able to multi-task and prioritize competing demands/work load

- Proven flexibility and adaptability

PPD is an Equal Opportunity Employer.

In order to apply, please submit your CV in English.