Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Issy-les-Moulineaux

Description

The Q&C Specialist is responsible for performing activities within the assigned country/countries that (1) ensure an integrated and comprehensive quality compliance approach for clinical trials in close collaboration with local and global quality 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. 

The Q&C Specialist reports into the Q&C Manager and is a member of the regional Q&C management team. 

PRINCIPAL RESPONSIBILITIES:

Quality 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
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., T-Race, IRON)

Collaboration with Business Quality
Support LOC Management Review in collaboration with LOC Business Quality partnersSupport local vendor assessments as appropriate
Support annual Due Diligence update, certification and training of local vendors, if applicable

Qualifications
EDUCATION & EXPERIENCE REQUIREMENTS:

Education: 
A minimum of a Bachelor 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 country-specific 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 
Flexible and persistent 
Good conflict handling/negotiation skills 
Excellent knowledge of English is required 
Proficient in Microsoft Office applications 
Able to create win-win 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 local and regional strategy
Nature of Communication - Influences or persuades others within area of immediate responsibility, scope and level

About the company

If you’re thinking about taking your career to a place where you can be seen for the talent you bring to your work, where you’ll have a chance to be the driver of your own career, and where others share your passion for caring and success, then we invite you to explore Johnson & Johnson. BE VITAL in your career and make a unique mark. Join the approximately 129,000 men and women who work within our companies and touch the lives of more than a billion people around the world every day.

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