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Pharma Quality Director (m/f/d) - Job - Karriere: ESTEVE

Pharma Quality Director (m/f/d)

Pharma Quality Director (m/f/d)

Advancing in innovation to improve people's lives has been our mission since our establishment in 1929. We are a global pharmaceutical company, headquartered in Barcelona, with pharmaceutical affiliates in Spain, Germany, France & the UK, and with state-of-the-art industrial sites in Mexico and China to serve our CMO business worldwide. This pharmaceutical and CMO platform allows us to continue to serve the medical needs of patients with passion and commitment.

Safety, Quality and Environment (SQE) is an organization with approx. 300 employees, reporting to the Executive Management of ESTEVE. SQE is recognized as a highly knowledgeable partner, working with a global mindset, while assuring compliance with the local regulations and requirements.

Each act of our Quality Team is a gesture that helps a patient.

If you are driven by purpose and would like to work for a company living an incredible transformation journey and where we continuously have an opportunity to write our future, this position is for you. We are a growing team, where you can find a great and diverse community, full of development and career opportunities.

                                        Join our team at the Berlin site as

                                           Pharma Quality Director (m/f/d)

The Role

The Pharma Quality Director is part of the Germany Country Leadrship Team, as well as part of the Global Quality Pharma Leadership Team.

The mission of this role is to manage the German Quality Pharma team to assure Compliance with the European Union Good Manufacturing Practice of medicinal products (EU-GMP and US CFR 21), along with compliance with the European Union Good Distribution Practice of medicinal products (EU-GDP), complemented by the requirements for quality and regulatory compliance for any products commercialized by ESTEVE both in Germany and “Rest of the World” Countries.
 

  • Guarantee the Quality standard application related to the pharmaceutical activity (GMP’s and GDP’s) in Germany and in “Rest of the World” Countries where Esteve products are marketed
  • Provide Quality Germany unit with suitable resources (human and technological) and establish the action priorities in each case
  • Implement Quality Standards and work with the aim of constantly improving the quality of the products
  • Assure that Quality Policy, Quality Manuals and Global Directives are implemented in the German Affiliate thereby ensuring the implementation of all Quality Systems (Change Control, Deviations,Complaints, etc) - all within the Pharmaceutical Quality System
  • Ensure notification, as per Quality Policy, of any relevant issues concerning quality incidents and their aproppiate follow-up
  • Establish and comply with the annual budget for the area
  • Assure that defined metrics are in place and establish action plans to ensure continuous improvement and the effectiveness of systems & processes, as well as defined indicators of Quality
  • Act as main contact with Health Authorities for Pharmaceutical Products
  • Responsible to ensure that the person or entity, to whom any task or activity has been delegated, possesses the required competence, information and knowledge to successfully carry out the outsourced activities
  • Review and control of the CMOs related with the pharmaceutical authorization or finished product Failure investigations (deviations, rejections, complaints) in addition to ensuring through the different quality systems complete alignment of CMOs with Esteve Quality Policies
  • Guarantee the completeness of the review of documentation for the release of a drug product on the market
  • Establish and maintain control over activities to ensure compliance within management of products to be sold
  • Organize and actively assist within Quality Audits and Inspections planned by authorities or other parties
  • Promote technical knowledge and quality risk assessment
  • Participate in new projects to ensure internal compliance of the GMPs in the different stages of the life of a project
  • Promote continuous improvement of workplace processes by identifying and proposing initiatives that lead to maximum efficiency in the use of available resources
  • Promote good communication and collaboration between involved departments, through a good established governance
  • Assure self continuous education to maintain current knowledge about requeriments in German market and Rest of the World markets
  • Actively contribute as a member of ESTEVE Germany Leadership Team to local management decisions

 

Your Profile

The ideal candidate has a strong background in Quality within the Pharmaceutical Industry.

Personal Skills:

  • Team player with the ability to work in a multidisciplinary and multicultural team and to collaborate transparently with different departments within the company
  • Outstanding communication and influencing skills
  • Passion for continuous improvement
  • Good business acumen
  • Flexibility and ability to adapt to change
  • High level of energy
  • High willingness to learn and grow
 
Qualifications:
  • At least five years of experience in Quality areas within a Pharmaceutical company, preferably also including experience in a manufacturing site
  • Knowledge in Regulatory Affairs & experience in management of Medical Devices and Food Suplements are a plus.
  • Education: Sciences Degree with Specialization in Pharmaceutical Industry, Postgraduate in Quality Direction and/or Degree in Pharmacy is a plus
  • Fluent in English and German written and spoken
  • Previous international experience and the will to move geographically would be valued

Our offer:

  • A dynamic workplace in a growing international pharmaceutical environment 
  • Open-minded and modern working environment
  • Further education and training
  • Travel allowance for public transport
  • 30 days holiday
  • Lunch allowance
  • Mobile work (10 days / month)
  • Employee discounts
  • Performance-related bonus
  • Yearly salary review
  • Employee referral programme
  • Subsidized Deferred compensation for retirement benefits
  • Sustainability and environmental protection in the focus of the company

At ESTEVE, you can make a difference without having to fight against corporate structures.

Ideas and entrepreneurship are very important to us, because as a company we don't want to stand still any more than our employees do.

Get moving with us and send your resume online in english, as well as a cover letter to our HR department.

ESTEVE Pharmaceuticals GmbH

Human Resources Department

Hohenzollerndamm 150-151

14199 Berlin

Submit application

WIR sind ESTEVE

ESTEVE ist ein weltweit tätiges Spezialpharmaunternehmen mit mehr als 90 Jahren Erfahrung und pharmazeutischen Niederlassungen in Spanien, Deutschland, Frankreich und Großbritannien.

Außerdem verfügt es über hochmoderne Industriestandorte in Mexiko und China, um das CMO-Geschäft abzudecken. Die pharmazeutischen und CMO-Plattformen ermöglichen es ESTEVE, weiterhin mit Leidenschaft und Engagement den ungedeckten medizinischen Bedarf der Patienten zu bedienen.

Innovationen voranzutreiben, um das Leben der Menschen zu verbessern, ist die Mission von ESTEVE seit seiner Gründung.

International aufgestellt, aber nicht abgehoben. Professionell geführt, aber nicht festgefahren.

Bewegen Sie sich - und uns

Bei ESTEVE können Sie etwas bewegen, ohne gegen Konzernstrukturen ankämpfen zu müssen.

Ideen und Unternehmertum werden bei uns groß geschrieben, denn wir wollen als Unternehmen genauso wenig stehen bleiben wie unsere Mitarbeiterinnen und Mitarbeiter.

Bewegen Sie sich mit UNS!

Was Sie bei ESTEVE erwartet

Durch flache Hierarchien, modern ausgestattete Arbeitsplätze und kurze Entscheidungswege geben wir Ihnen Gestaltungsfreiraum für Ihre Ideen. 

Ein verantwortungsvolles und anspruchsvolles Aufgabengebiet in einem internationalen Arbeitsumfeld wartet auf Sie. Wir fordern und fördern unsere Mitarbeiter gezielt und aktiv. 

Überzeugen Sie sich selbst!