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Senior Manager, External Supply Manufacturing Operations Quality - Medical Devices

Date: Sep 22, 2022

Location: Zagreb, HR, 10000

Company: Teva Pharmaceuticals

Who we are

 

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. 

We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Your responsibilities 

 

As a Senior Manager, EMSO Quality - Medical Devices you will actively participate in projects to implement Medical Device Regulation (MDR) requirements for in-house manufactured and third party produced substance-based Medical Devices as well as EMSO-related combination products. 


In this role, you will…

 

  • Act as a project lead driving progresses, securing monitoring and ensuring timelines
  • Take responsibility for the Technical Documentation of Medical Devices and work closely with interdisciplinary teams, both internally and externally
  • Ensure correct implementation of the Unique Device Identification (UDI) System for in-house manufactured and third party produced substance-based Medical Devices (class III, IIb, IIa, I devices)
  • As an EMSO EU Quality SME, you will be part of compliance projects/initiatives to secure continuous improvement
  • Take responsibility for Quality oversight of Non-Pharma products and Supplier Management
  • Act as a Responsible Person for Regulatory Compliance according to Article 15, MDR (preferred)

Your profile

 

  • Bachelor’s or Master’s degree in Science or Engineering 
  • 3+ years’ experience working in the pharmaceutical or medical device industry
  • Profound knowledge in national and international regulations and guidelines (MDR 2017/ 745, ISO 13485, ISO 14971, Meddev. 2.7.1) – required 
  • Strong technical expertise - highly desired
  • Proven experience in the creation of product specific technical documentation according to MDR
  • Experience with the elements of Quality Management Systems such as risk management, change control, deviation, complaints, CAPAs, supplier qualification, post-market surveillance and documentation management systems
  • Experience with substance-based medical devices or other devices such as syringes, auto-injectors, nasal sprays, and transdermal patches - desired 
  • Experience with 1st, 2nd and 3rd party audits - desired
  • Excellent organizational and interpersonal skills
  • Experience in project management - desired
  • Strong computer skills (MS Office, SAP and TrackWise) 
  • Oral and written fluency in English 

Role location

 

We are recruiting for two positons:

 

1. Senior Manager, External Supply Manufacturing Operations Quality - Medical Devices, Ulm, Germany
2. Manager / Senior Manager, External Supply Manufacturing Operations Quality - Medical Devices, Zagreb, Croatia or Sofia, Bulgaria

 

Function

Quality

Sub Function

Quality Assurance Methods

Reports To

Associate Director, EMSO Quality EMEA - Medical Devices

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.