PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!
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.
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 well-being of our employees.
As QA Auditor III/Compliance Manager within the Quality Investigation and Support team, you will be involved in multiple aspects of quality assurance.
Provides guidance to operational departments as a subject matter expert (SME) for regulations, ICH GCP guidance, and PPD SOPs. Provides support to clients and internal teams for regulatory inspections of sponsors and investigator sites. Leads/coordinates investigation of suspected scientific misconduct cases. May perform directed audits and provide audit reports to management. Identifies issues impacting the quality and/or integrity of clinical research programs, determines root cause of non-conformance and develops strategies to address issues.
Provides GCP consultation and support to PPD project teams and external clients
Provides support to clients and internal teams for regulatory inspections of sponsors and investigator sites
Leads/coordinates investigation of suspected scientific misconduct cases including conduct of directed audits
Serves as a resource to operational departments on audit or quality assurance subject matter
Prepares and presents audit findings and/or other related information at departmental, internal operations or client meetings
Provides mentorship and guidance to junior auditors
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience.
Knowledge, Skills and Abilities:
Thorough knowledge of GxP and appropriate regional research regulations and guidelines
Demonstrated proficiency and led a range of project based or internal GxP audits and vendor audits to high standards required by management
Excellent oral and written communication skills
Strong problem solving, critical thinking, risk assessment and impact analysis abilities
Solid experience in root cause analysis
Above average negotiation and conflict management skills
Flexible and able to multi-task and prioritize competing demands/workload
PPD Defining Principles:
We have a strong will to win - We earn our customer’s trust - We are game changers - 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.
PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.
- Srbija, Beograd, Ljubostinjska 2 11000 Beograd
- PIB: 107062915
- Matični broj: 20735023