Global Research & Development QMS Manager

Band

Level 4

 

Job Description Summary

LOCATION: Barcelona, Spain
ROLE TYPE: Hybrid working. #LI-Hybrid

As a Global Research & Development Quality Management System Manager (Global R&D QMS Manager) you will be a key functional expert, driving GxP (Good Practice) Compliance, efficiency and productivity gains through development, implementation and management of the R&D QMS via End-to-End documentation life-cycle process and development and management of adult learning contents. This enables the organization to mitigate performance gaps, achieve full regulatory QMS compliance, facilitate GxP knowledge transfer and meet its business and strategic objectives.

You will also drive the design and implementation of robust quality-related training programs with innovative learning technologies, processes, and adult learning solutions, to facilitate continued growth and development of R&D personnel.

 

Job Description

Major accountabilities:

• Responsible for ensuring GxP QMS compliance at Research & Development (R&D) by means of:

• (Standard Operating Procedure) SOP writer: provide support training and guidance to document authors, board members and any stakeholder to create/update properly R&D QMS documents according to Novartis (NVS) and GxP requirements. Provide QMS review of documents.

• SOP trainer: provide support, training and guidance to document authors, Training members and any stakeholder to create/update appropriate R&D QMS Training contents and process/task-based curricula according to NVS and GxP requirements, ensuring globally harmonized approach as part of job qualification in the Learning Management System (LMS). 

• SOP Manager: Support stakeholders and manage the document life-cycle activities in Data Lifecycle Management (DLM) tool for R&D functions.

• Active partner in QMS networks and expert panels to ensure collaboration for a streamlined, innovative and compliance QMS throughout NVS and advise on procedural documents and training strategy, change requests, risk and impact assessments.

• Effectively establish, deepen, and sustain key relationships with R&D and Research, Development, and Quality (RDQ) senior stakeholders, and demonstrate an understanding of processes and methodology in order to provide appropriate QMS review and learning solutions.

• Take on senior project management responsibilities by leading the development and delivery of required training programs and QMS Improvements & projects according to timeline, regulatory and budget specifications.    

• Be a role model for the NVS values and behaviors and support the journey towards an inspired, curious, unbossed and self-aware organization. 

Ideal Background

• Min. 5-7 years in pharmaceutical industry, preferably development.

• Training and/or Curricula development experience plus preparation, development and administration of document management & training programs and systems 

• Demonstrated leadership in implementing robust training programs and quality management systems in a GxP regulated area 

• Excellent English language skills.

• Knowledge of Total Quality Management (TQM) and related industry GxP standards and processes

• Knowledge of compliance requirement for external regulations (Good Cliical Practice (GCP), International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), International Organization for Standardization))

• Strong knowledge of Quality Standards, Quality decision making & Risk Management

• Bachelor degree in Life Sciences or related fields (an advanced degree and/or MBA would be an advantage)

Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams'