QA Auditor III GCP / Compliance Manager, No Travel, Remote / Some EMEA locations
Thermo Fisher Scientific
Bucharest RO West Gate Park, RO
2 zile în urmă

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services - 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 quality 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 QA Auditor III / Compliance Manager within the Quality Investigation and Support team, you will be involved in multiple aspects of quality assurance.

Summarized Purpose : 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.

Essential Functions : * 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 qualificationPrevious 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.
  • At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team.

    We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

    As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees.

    We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together.

    We are a global organization but with a local feel. Our 4i Values : Integrity Innovation Intensity InvolvementIf you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application we’d love to hear from you!

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