Quality Affairs Manager Greece, Cyprus, Israel

Athens - Greece

Monthly Salary: Not Disclosed

Posted on: 17 hours ago

Vacancies: 1 Vacancy

Job Summary

Title:

Quality Affairs Manager Greece Cyprus Israel

Company:

Ipsen Single Member EPE

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology Rare Disease and Neuroscience. Supported by nearly 100 years of development experience with global hubs in the U.S. France and the U.K we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration excellence and impact. At Ipsen every individual is empowered to be their true selves grow and thrive alongside the companys success. Join us on our journey towards sustainable growth creating real impact on patients and society!

For more information visit us at follow our latest news on LinkedIn and Instagram.

Job Description:

Summary / purpose of the position

Act as the Quality Affairs Manager and Responsible Person at Ipsen Greece.

The Quality Affairs Manager is responsible for the overall management of the Affiliate Quality Management System and Quality Affairs programs to foster a strong quality and continuous improvement culture and thus ensuring that the local license to operate activities meet internal and external requirements (including regulations and Good x Practices) policies and procedures.

Main responsibilities/job expectations

Quality Affairs

Ensure all quality activities are delivered in line with local guidelines legislation as well as local and global Ipsen Policies and SOPs and ensure that the affiliate has a comprehensive Local Quality Management System
Prepare review and update local SOPs related to Good Distribution Practice on a regular basis
Manage self-inspections annually
Responsible for the conduction of contractor audits
Coordinating and preparing for authority GxP inspections and internal global GxP audits and supporting the development of responses to findings
Participate in authority inspections and internal audits from global audit team
Ensure induction training and annual training is conducted with respect to GxP
Ensure processes are in place for deviations CAPAs change control and risk management
Ensure that product complaints and recalls are handled effectively according to local and global SOPs
Handles all matters concerning potential recalls
Takes decision after consultation with Global Quality group on the disposition of imported batches should any product quality defect be identified.
Communicates with local Medical Agencies concerning product quality matters
Document and track deviations related to GxP and ensuring that appropriate CAPA are developed and implemented to address issues with compliance

GxP Training Officer

Ensure that each new employee gets a correct GxP induction and that a training file is created
Ensure that local processes for GxP training are in place
Ensure that new employees get access to Ipsen Learning Platform (iLearn) Easidoc and ensures they are trained in local SOPs according to local matrix
Responsible for that all employees are trained in complaints handling yearly and that all training records are filed correctly

Knowledge abilities & experience

Education / Certifications:

Ideal: Degree or equivalent work experience in scientific or health related field
Minimum: Degree in Scientific discipline (Pharmacy Chemistry or Biological Sciences)

Experience:

At least 5 years experience in a similar position in a multinational pharmaceutical company
Strong quality orientation
Working in a matrix organization and interfacing with lead/management team.
Ability to work with high workload and time pressure
Strong organizational abilities
Ability to balance between detail orientation and overview with a good business acumen
Broad pharmaceutical business knowledge
Proven experience and leadership within Quality operations of multi-national biopharmaceutical settings;
Extensive understanding of GxP Quality Systems and Pharmaceutical responsibilities with experience as Local/Site QA Lead or Representative.

Languages:

English: full professional proficiency

Key Technical Competencies Required

Acts as a Business Partner
Ethical behavior
Sense of urgency
Analytical problem-solving and high-level organizational and time management skills;
In-depth knowledge of relevant bio-pharmaceutical legislation and QMS requirements including GxP standards Pharmacovigilance regulations.
Good understanding of operational platforms and validated databases to execute GxP quality compliance
Demonstrated LQA capabilities including affiliate QMS set up implementation and maintenance;
Ability to thrive in cross-functional environment (matrix organization)
Ability to influence negotiate and project manage

We are committed to creating a workplace where everyone feels heard valued and supported; where we embrace The Real Us. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.

Required Experience:

Manager

Title:Quality Affairs Manager Greece Cyprus IsraelCompany:Ipsen Single Member EPEAbout Ipsen:Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology Rare Disease and Neuroscience. Supported by nearly 100 years of development...