Quality, Compliance and Local Submission Manager
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.
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.