Local Compliance Specialist

1 settimana fa

Cologno Monzese, Lombardia, Italia Johnson & Johnson A tempo pieno

The Local Compliance Specialist is responsible for performing activities within the assigned country/countries that (1) ensure an integrated and comprehensive quality and compliance approach for clinical trials in close collaboration with local and global quality and compliance functions, and (2) ensure clinical trials are performed in compliance with local laws and regulations, industry standards and Johnson & Johnson / Janssen global processes and procedures.


Principal Responsibilities:
Quality and Compliance Oversight Activities

  • Monitor compliance risk and ensure mitigation/remediation actions are defined
  • Monitor progress and confirm effectiveness of remediation plans, e.g. by performing QC checks or special investigations and plan, prepare, conduct and report QC checks and compliance assessments to ensure risk signals are addressed in a timely manner.

More specifically perform the following riskbased activities:

  • Conduct On-Site Compliance Monitoring Visits
  • Perform assigned reviews of Trial Master File, training compliance documentation and other checks per QP&S Integrated Quality Plan for the trial
  • Planning and execution of local QC checks
  • Support and advise local and central study teams in root cause analysis of significant observations
  • Ensure appropriate filing of the QC reports
  • 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.
  • Collaborate with local and central business partners in timely CAPA setting and implementation. Provide Quality Event Management (QEM) CAPA Champion support. Moderate level of risk awareness and ability to translate risks into actions
  • Support the local impact assessment of global procedural documents and if applicable support development and management of associated local procedural documents
Local Onboarding and Consultation

  • Support onboarding of new hires
  • Manage local workshops to support QMS and compliance awareness, Lessons Learned, etc
  • Provide advice regarding SOP, system and GCP questions of moderate complexity
  • Supports managing risk at the country level, including assessing root causes and developing effective actions to mitigate risk
Local regulatory intelligence

  • Perform impact assessments of new/revised local regulations, guidance and standards
  • Support central functions in ensuring local intelligence is up to date (e.g., RIACS, T-Race, IRON)
Collaboration with Business Quality

  • Support LOC Management Review in collaboration with LOC Business Quality partners
  • Support local supplier assessments as appropriate
  • Support annual Due Diligence update, certification and training of local suppliers, if applicable

Principal Relationships:
The Local Compliance Specialist has a dual reporting line into the
and
or
, and is a member of the
Compliance team.

Qualifications:

Education and Experience Requirements:

Education:


A minimum of a Bachelor's Degree in Science (BSc) or Arts (BA) or 4-6 years relevant experience equivalent is required.

A minimum of 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.


Related Experience:

  • Knowledge of the overall drug development process
  • Developing or developed skills and knowledge of business processes and practices (i.e., SOPs governing clinical research activities)
  • Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an asset
  • Ability to translate data into information and strategies into executable action plans improving the business
  • Ability to motivate professional colleagues and stakeholders
  • Conflict resolution/management and negotiation skills
  • Ability to independently plan, organize, coordinate, manage and execute assigned tasks
  • Experience of the key customers' business processes and practices
  • Good working knowledge of FDA/ICH and countryspecific regulations and guidelines related to clinical development
  • Experience with regulatory submissions (NDA, BLA) is an asset

General Skills:

  • Problem solver
  • Collaborator
  • Highly committed to quality and compliance
  • Flexible and persistent
  • Good conflict handling/negotiation skills
  • Able to create winwin situations with internal and external partners
  • Knowledge of the corporate structure and culture


 Impact
  • Complexity and Scope
  • Contributes to the definition and development of new processes, standards or operational plans in support of the organizational/ business strategies, with a direct impact on business unit/function overall results.
  • Typically has responsibility for smaller scope projects.
  • Manages limited number of projects, including some of moderate complexity. Leads smaller scope projects.
  • Contributes to lo

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