GCO Local Compliance Specialist
Johnson & Johnson
- Praha
- Trvalý pracovní poměr
- Plný úvazek
- 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
- 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