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Quality

GCO Local Compliance Specialist

  • Titel GCO Local Compliance Specialist
  • Functie Quality
  • Sub functie Clinical Quality
  • Categorie Experienced Analyst, Clinical Quality (P5)
  • Locatie Prague, Czech Republic
  • Gepost
  • Referentie 2406177419W
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Beschrijving

Global Clinical Operations (GCO) Local Compliance Specialist

Location.: Czech Republic

Full time job 

We are looking for a driven Local Compliance Specialist to join our Global Clinical Operations (GCO) team in Czech Republic. We are seeking to hire a strong communicator, a teammate and someone with analytical skills, with quick learning and problem-solving abilities. If you are flexible, persistent and able to work independently, we'd love to hear from you.

In this role Compliance Specialist is responsible for performing activities ensuring an integrated and comprehensive quality and compliance approach for clinical trials. You will collaborate with the Compliance Manager, the Country Head, the Clinical Research Managers and the local teams carrying out the clinical trials, ensuring clinical trials are performed in compliance with local laws and regulations, industry standards and Johnson & Johnson global processes and procedures. You will be part of a hardworking, enthusiastic, and committed team eager to deliver and helping to improve the lives of millions of patients.

Key Responsibilities:

  • Monitor compliance risk and ensure mitigation/remediation actions are defined
  • Plan, prepare, conduct and report QC checks, special investigations, and compliance assessments to ensure risk signals are addressed in a timely manner. More specifically perform the following risk based activities: Compliance Monitoring Visits, Trial Master File reviews, local QC checks, support study teams in root cause analysis of significant observations.
  • Support Quarterly Quality Reviews with local GCO management addressing compliance issues and risk signals
  • Collaborate with local and central business partners to facilitate (local) inspections and office audits as needed
  • Support and cooperate with local and central business partners in timely CAPA setting and implementation. Provide Quality Event Management CAPA Champion support.
  • Support local onboarding activities and provide advice regarding SOPs, systems and GCP questions to the local team
  • Support managing risk at the country level, including assessing root causes and developing effective actions to mitigate risk
  • Perform impact assessments of new/revised local regulations, guidance and standards
  • Keep local regulatory intelligence up to date
  • Support LOC Management Review in collaboration with LOC Business Quality partners
  • Support local suppliers assessments, training and oversight, as appropriate
  • Assume additional responsibilities or special initiatives such as 'Champion', ''Subject Matter Expert' or 'Business Process Owner', for local processes

Kwalificaties

Qualifications

Education:

A minimum of a Bachelor Degree in Science (BSc) or Arts (BA) or 4-6 years relevant experience equivalent is required. At least 3 years of previous Pharmaceutical Industry experience is required, with at least 2 years of GxP experience within clinical research and development and/or quality assurance.

Experience and Skills:

Required:

  • Good working knowledge and confirmed understanding of ICH GCP , local laws, and regulations
  • Ability to present in a clear and concise way - strong communication skills
  • Strong interpersonal and negotiation skills and ability to empower colleagues and stakeholders
  • Proven project management skills
  • Ability to translate data into information and strategies into executable action plans improving the business
  • Ability to independently plan, organize, coordinate, manage and execute assigned tasks
  • Real diplomate that can understand impact and complexity of the situation, with the ability to create win-win situations
  • Experience in quality assurance activities, including audits of clinical investigative sites , systems and vendors, and audits of regulatory submissions is an asset
  • Highly committed to quality and compliance

Other:

Excellent knowledge of English and proficiency in Microsoft Office applications are required. Travel up to 25%, both local and regional, may be required.

This is what awaits YOU at J&J:

·       An opportunity to be part of a global market leader.

·       A dynamic and inspiring working environment.

·       Many opportunities to work on challenging projects and assignments.

·       Possibilities for further personal as well as professional development.

·       Many employee benefits.

Employee benefits are regulated by an internal policy that contains full details regarding the entitlement and conditions for the benefits.

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences

That is why we in Johnson & Johnson are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

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