At The Janssen we are dedicated to addressing and solving some of themost important unmet medical needs of our time in oncology immunologyneuroscience infectious diseases and vaccines and cardiovascular andmetabolic diseases. Driven by our commitment to patients we bringinnovative products services and solutions to people throughout the is a pharmaceutical company of Johnson & Johnson. Pleasevisit mfor more information.

Janssenpart of Johnson & Johnson Family of Companies is now looking for anexperienced Quality Compliance and LocalSubmission Manager

Quality Compliance and LocalSubmission Manager

Located inBudapest

Contract: Unlimitedcontract

Main Tasks:

Quality and Compliance:

• The Q&C Manager isresponsible for performing activities within the assigned country/countriesthat (1) ensure an integrated and comprehensive quality compliance approach forclinical trials in close collaboration with local and global quality functionsand (2) ensure clinical trials are performed in compliance with local laws andregulations industry standards and Johnson & Johnson / Janssen globalprocesses and procedures.
• The Q&C Manager has adual reporting line into the Local GCO CM (solid line) and Regional Quality andGCP Manager (dotted line) and is a member of the GCO CENA Q&C may oversee and direct one or more Q&C Specialists.

Local Submission:

• Ensure full oversight oflocal clinical trial submission and preparatory activities.
• Ensure that submissionactivities comply with Company procedures policies and local regulatoryrequirements. Perform regulatory submission document review and approval.
• Support Local TrialManager and Site Manager to ensure optimal management of all submission relateddocuments with logistical and administrative tasks related to trial start-upexecution and closing of clinical trials.
• May contribute to process improvementand training related to regulatory submission activities.

Crucial Requirements for Candidates:

Aminimum of 6 years of previousPharmaceutical Industry experience is required with at least 4-5 years of GCPexperience within clinical research and development and/or quality assurance.

Knowledge of the overall drug development process

Knowledge of business processes and practices (i.e. SOPsgoverning clinical research activities)

Experience in quality assurance activities including audits ofclinical investigative sites systems and vendors and audits of regulatorysubmissions is an asset

Strong personal leadership skills with demonstrated competencyinterfacing with all levels of the organization including senior leaders; Strongnetworking and relationship building skills; Ability to create an open andinviting environment; Embraces generational differences; Exceptional writtenand verbal communications skills

Experience in R&D process requirements to successfully driveQ&C productivity strategy optimization process improvements andefficiencies including development and management of CAPA and facilitation ofRoot Cause Analysis

Ability to translate data into information and strategies intoexecutable 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 andexecute assigned tasks

Experience of the key customers business processes and practices

Excellent working knowledge of FDA/ICH and country-specificregulations 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 aglobal market leader.

A dynamic and inspiring workingenvironment.

Manyopportunities to work on challenging projects and assignments.

Possibilitiesfor further personal as well as professional development.

Many employeesbenefits.