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Contract Manufacturing Organisation Quality Manager

Date: May 4, 2021

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

CMO Manager will have to guarantee that current pharmaceutical standards, legal regulations and approved registrations are implemented for the production and the controlling of Third Party manufactured products. Your main responsibilities include: 

 

   Product Management

  • Supervise the entrusted products through the entire life cycle with regard to pharmaceutical quality
  • Take actions needed to assure the products quality and compliance - initiate, coordinate and supervise activities that are carried out by the relevant expert team for the purpose
  • Close cooperation with Qualified Persons and Quality Officers as well as responsible Teva departments in tasks or meetings related to critical quality issues to provide a thorough and profound basis for decision-making
  • Implement and support projects within the department to ensure compliance with internal standards

 

   Supplier Management

  • Internal and external contact person for all issues concerning the pharmaceutical quality of third party manufactured products
  • Coordinate and control all GMP relevant documents with regard to manufacturing process, quality control and quality assurance
  • Collate key quality performance metrics and trends agreed with CMOs
  • Collect status of Quality improvement actions (derived from audits, deviation & complaint investigations, risk assessments
  • Provide Quality and Performance KPIs, prepare reports on audit outcomes and other major quality events or concerns

 

     Change Management

  • Ensure all changes concerning Module 3 of a dossier are submitted to the authority in collaboration with TPM and Regulatory Affairs
  • Reply to deficiency letters (DL)
  • Additional responsibilities
  • Supplier Qualification - QA Due Diligence of Existing Contract Manufacturer and Master Documents Authorization to assure regulatory compliance on the supplier’s level
  • Participation in Technical Visits/Audits
  • Review of Procedure Qualification Records (PQRs)
  • Release of GMP Documents

Your profile

  • University degree in Pharmaceutical, Natural or Engineering science
  • Professional experience either in quality control/analysis/assurance role or in supplier management role in a GxP or ISO regulated environment
  • Strong knowledge of MS Office applications, SAP instances and TrackWise QMS
  • Excellent communication skills
  • Organizational and planning skills
  • Excellent diplomacy and influencing skills
  • Good command of written and spoken English language

Function

Quality

Sub Function

Supplier Quality

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.