Quality and Safety Director 328469

Novo Nordisk; Puteaux; Sur place; EUR 60 000 - 100 000; Plein temps

Résumé du poste

An established industry player is seeking a Quality Safety Director to lead quality management in France. This role focuses on implementing quality policies, enhancing QA processes with AI, and ensuring compliance with pharmaceutical regulations. The ideal candidate will have a strong background in quality assurance, pharmacovigilance, and a commitment to continuous improvement. Join a dynamic team dedicated to maintaining high standards of quality and safety in pharmaceutical operations, impacting millions of lives globally. This is a unique opportunity to contribute to meaningful change in healthcare.

Qualifications

• 5-10 years of experience in Quality Assurance and certified as an auditor.
• Extensive knowledge of pharmaceutical legislation regulations and GXP requirements.

Responsabilités

• Manage safety activities and legislation surveillance as the reference person for pharmacovigilance.
• Lead the QA and PV team focusing on team management and employee development.

Connaissances

Quality Assurance

FDA Regulations

ISO 9001

Root Cause Analysis

Biotechnology

Clinical Trials

Quality Systems

Food Processing

Quality Control

Quality Management

cGMP

HACCP

Formation

Pharmacist education

Training in Quality Assurance and safety

Description du poste

Are you a seasoned professional with a passion for quality management and safety in the pharmaceutical industry? Do you have a strong background in Good Distribution Practices and a knack for cross-functional collaboration? If so, we invite you to explore this exciting opportunity to join Novo Nordisk as a Quality Safety Director in France. Read more and apply today for a life-changing career.

The position

As our Quality Safety Director at Novo Nordisk, you will ensure a common vision and strategy related to quality management is implemented in Business Area France. You will embody a QA (quality assurance) mindset at the affiliate level and set up and communicate the Quality policy as well as adjust QA policy to align with the current environment, product status, and business dynamics.

Your main accountabilities will include:

• Target efficiency in QA processes using AI as an enabler and promoting a risk-based approach.
• Implement and maintain the Novo Nordisk Quality Management System in France (supply promotional activities, pharmacovigilance, medical information, sales, marketing, market access, patient experience).
• Manage safety activities and related legislation surveillance as the national reference person for pharmacovigilance.
• Organize scientific information and customer service activities to support Responsible Pharmacist.
• Lead the QA and PV team focusing on team management and employee development and act as Deputy Responsible Pharmacist in France when necessary.

Qualifications

To be successful in this role we expect you to have:

• Pharmacist education with good knowledge of Good Distribution Practices.
• Training in Quality Assurance and safety.
• Very good knowledge of English.
• 5-8 years of experience in the pharmaceutical industry.
• 5-10 years of experience in Quality Assurance and certified as an auditor.
• 5-10 years of experience in pharmacovigilance activities.
• Extensive knowledge of pharmaceutical legislation regulations, ISO, and GXP requirements.
• Up-to-date knowledge of national legislations and guidelines.

On the personal level, you should have strong communication and relationship skills with all department functions. Skills for understanding and analysis of data reports and critical situations and ability to make decisions and demonstrate good organization and rigor. Management skills and a commitment to continuous improvement and innovation.

About the department

Join our Pharmaceutical Affairs Department / Quality and Safety Unit in France, part of the EUCAN region. Our team is dedicated to maintaining the highest standards of quality and safety in all our pharmaceutical operations. We foster a collaborative and supportive atmosphere where innovation and continuous improvement are at the forefront of our mission. Located in France, our department plays a crucial role in ensuring the quality and safety of Novo Nordisk products across the region.

Working at Novo Nordisk

Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 72,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we're working toward something bigger than ourselves and it's a collective effort. Join us! Together we go further. Together we're life changing.

Contact

For further information please apply your CV via the online recruitment system. We thank all applicants for their interest; however, only those candidates selected for interviews will be contacted.

Deadline

Please apply before April 30th.

Required Experience:

Director

Key Skills

Quality Assurance, FDA Regulations, ISO 9001, Root Cause Analysis, Biotechnology, Clinical Trials, Quality Systems, Food Processing, Quality Control, Quality Management, cGMP, HACCP