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Manager Quality Professional, R.P. - Commercial Quality Europe Region

Date: Apr 7, 2021

Location: Amsterdam, NL, 1019

Company: Teva Pharmaceuticals

Our company

Teva API B.V. is a stand-alone business unit within Teva Pharmaceutical Industries, the world’s largest generic drug manufacturer and one of the 15 largest pharmaceutical companies worldwide.

 

The rich history of Teva API B.V. dates back to 1935 with the founding of Assia, a company that specialized in the production of veterinary and pharmaceutical ingredients. Over the years, Teva API B.V. has acquired and established top-rated manufacturing and development facilities around the world. Each facility goes through a comprehensive integration program to align with the company’s high standards and best practices.

 

Today Teva API B.V. operates 15 production plants and 6 R&D centers across the globe. Each facility contributes to our ongoing excellence in research and development, production and customer service.

 

Teva API B.V. is located at Teva’s European Headquarters in Amsterdam the Netherlands.

Your role

The main purpose of your job will be to ensure compliance is in place for securing Active Product Ingredients (APIs) of Teva API B.V., are well distributed according current EU Directive 2015/C/95/01 with an active management of compliance activities, quality risk management, escalation of risks, and continuous improvement.

Your role will include providing the Quality Management System (QMS) and governance through strong collaboration with the Quality teams of the API manufacturing Sites, to foster excellence in management of items, on quality issues, regulations and expectations from authorities in line with current EU GDP API regulations and inspection readiness. In your role you will act as a Manager in staff named as Responsible Person on the API license of Teva API B.V. in the Netherlands at Teva’s EU Headquarters.

You will interact across the matrixed organization specifically with Teva Quality Compliance, the API manufacturing sites, supply chain operations, the customers and needed other network partner.

Thus, to ensure that the markets within the region receives the right level of support to maintain and enhance GDP, authority regulations compliance, with solving quality-related issues and identifying areas of improvement for quality performance in line with business needs and in accordance to Teva standards.

Moreover, you will foster, maintain and develop further the Teva API QMS and Quality compliance culture across the Active Product Ingredient climate in the Region.

Your responsibilties

  • Ensures distribution of APIs to the markets in accordance with the principles of Good Distribution Practice of active substance for medicinal products for human use 2015/C 95/01
  • Provides and ensures the Quality Management System is in place at Teva API B.V. and meets the requirements of the regulatory authorities and current best practice
  • Establishes and maintains an adequate quality system as such that distribution operations do not compromise the quality, safety or efficacy of the APIs controlled by Teva API B.V.
  • Focusses on the management of authorized activities and the accuracy and quality of records
  • Implements and maintains an initial and continuous training program
  • Ensures that relevant customer complaints are dealt with effectively and responded in a timely manner
  • Maintains a system in which suppliers and customers are approved and
  • Aligns any subcontracted activities which may impact GDP is evaluated and pre-approved
  • Supports and ensures changes are recorded, assessed and approved at an appropriate level
  • Connects on self-inspections to be performed at appropriate, regular intervals following a prearranged program and necessary corrective measures are put in place
  • Ensures GDP records are generated in accordance with company procedures and are archived and maintained such that they are easily retrievable on request
  • Ensures quality issues and non-conformances relating to APIs controlled by Teva API BV are recorded and escalated in accordance with Teva policy and the Notification to Management (NTM) procedure
  • Supports the design of what “success” looks like and implement readiness tools and preparedness
  • Works collaboratively with the quality teams in the market to perform activities on improvement there where needed

Your profile

  • Bachelor's Degree must – chemistry, pharmacy, healthcare or related science-based degree
  • Master's Degree preferred – in chemistry, pharmacy, healthcare, or an equivalent combination of education and experience related to Quality Assurance/Quality Control - advantage at large and complex sites
  • Experience: 10 years of experience as a functional manager with technical, team management, and operational responsibility.
  • 5 years’ experience in a Matrix environment
  • Demonstrated knowledge and working experience with government regulations for the cluster
  • In-depth knowledge of pharmaceutical industry as it relates to Quality Compliance
  • Working knowledge of pharmaceutical operations
  • In-depth understanding of GDP & new authority regulations
  • Experience with development and implementation of Quality Systems and application of risk assessment tools
  • Proficient computer skills in current software including MS Office
  • Excellent English proficiency
  • Continuous professional development

Function

Quality

Reports To

Head of Commercial Quality Europe, Senior Director

Pre-employment screening

Teva will carry out appropriate verification and legally permitted vetting prior to the confirmation of any offer of employment. More information on this verification and vetting will be provided if you reach this stage of the application process.

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.