Johnson & Johnson Careers

Quality, Compliance and Local Submission Manager

Budapest, Hungary
Clinical Trial Administration


Job Description

Requisition ID: 1905747277W

At The Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.  Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson.  Please visit www.janssen.com for more information.

 Janssen, part of Johnson & Johnson Family of Companies is now looking for an experienced Quality, Compliance and Local Submission Manager

 

Quality, Compliance and Local Submission Manager

Located in Budapest

Contract: Unlimited contract


Main Tasks:

Quality and Compliance:

  •        The Q&C Manager 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 Manager has a dual reporting line into the Local GCO CM (solid line) and Regional Quality and GCP Manager (dotted line), and is a member of the GCO CENA Q&C management team. He/she may oversee and direct one or more Q&C Specialists.

Local Submission:

  •        Ensure full oversight of local clinical trial submission and preparatory activities.
  •        Ensure that submission activities comply with Company procedures, policies and local regulatory requirements. Perform regulatory submission document review and approval.
  •        Support Local Trial Manager and Site Manager to ensure optimal management of all submission related documents with logistical and administrative tasks related to trial start-up, execution and closing of clinical trials.
  •        May contribute to process improvement, and training related to regulatory submission activities.


Qualifications

Crucial Requirements for Candidates:


·        A minimum of 6 years of previous Pharmaceutical Industry experience is required, with at least 4-5 years of GCP experience within clinical research and development and/or quality assurance. 

·        Knowledge of the overall drug development process

·        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

·        Strong personal leadership skills with demonstrated competency interfacing with all levels of the organization including senior leaders; Strong networking and relationship building skills; Ability to create an open and inviting environment; Embraces generational differences; Exceptional written and verbal communications skills

·        Experience in R&D process requirements to successfully drive Q&C productivity, strategy optimization, process improvements and efficiencies including development and management of CAPA and facilitation of Root Cause Analysis

·        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

·        Excellent working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development;

·        Experience with regulatory submissions (NDA, BLA) is an asset; 


In Return, We Offer:

·        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 employees benefits.


Primary Location
Hungary-Budapest-Budapest-
Organization
Janssen-Cilag Kft. (8396)
Job Function
Clinical Trial Administration
Requisition ID
1905747277W