Since 1929, ESTEVE has been driven by a clear and powerful purpose: improving lives together. Headquartered in Barcelona, ESTEVE have two main businesses: CDMO & Pharma.

ESTEVE CDMO, it's a global CDMO company with world-class production sites in Spain, Mexico, China and USA, and the Vision to be global CDMO leaders in small molecule APIs, trusted by partners for quality and reliability.

ESTEVE pharma business has affiliates in Spain, Portugal, Italy, Germany, France, the UK, and the Vision to be a global pharmaceutical company serving people with a need of highly specialized solutions.

At the heart of everything we do are our core values: people matter, transparency, and accountability.

We care, we do: Our commitment goes beyond medicine. We care about making a positive impact on people, the environment, and the way we do business.

1. JOB DESCRIPTION

Mission

To ensure and coordinate raw material/supplier compliance with the different national regulations in the Esteve Group, as well as the global and centralized harmonization of the Quality/EHS System that is applied in all its centers.

Principal Roles

• To ensure the total monitoring and compliance with the standard in Esteve (suppliers evaluation and qualification, change controls, complaints, etc).
• To manage and ensure compliance with the external regulations (REACH, GHS, Chemical weapons, drug precursors, special taxes, etc) on product stewardship.
• Provide expert technical guidance and assistance to internal and external customers on a wide variety of regulatory issues.
• To manage and ensure globally harmonized compliance with Supply Management/ Quality/EHS standards / procedures.
• Interface with multiple departments and suppliers for data collection, status updates, etc. Input and update regulatory and product/suppliers into data base applications and shared data platforms.
• Participation in Commercial Core Teams. Commercial relationships with suppliers and customers that correspond to the membership of the different Core Teams.
• Collaborate in the visits and evaluations of a part of the suppliers.
• Key user Computer applications (SAP/R3, SAP/4HANA, SAP ARIBA, IUCLID, Preactor APS).

Mobility

Availability to travel (aprox. 10%).

2. JOB RELATIONSHIPS

Internal Relations

• Local: Logistics, Production, R&D, Quality and Strategic Sourcing.
• Global: Quality, BD, CMO, FP&L, Finance, IT, EHS, Core Teams

External Relations

• Suppliers and customers (Third party)
• National and European authorities
• Support organizations (CEFIC, AFAQUIM, etc.)

3. JOB PROFILE

Required Education:

• Bachelor's degree in a technical or science-related field (Chemistry, Chemical Eng, Biochemistry...)
• Minimum of 5 years of Pharma/API experience
• Languages: English (according to MRCE): C1-C2. Spanish-Catalan bilingual.

Valuable:

• Working knowledge of GHS (Global Harmonized System of Classification and Labelling of Chemicals), EU REACH (Registration, Evaluation, Authorization and Restriction of Chemicals)
• Trackwise, Opentext, Cambridge Soft, SAP ARIBA SLP as user

Background

• Experience in Quality and Supply Chain areas
• Experience in computer software (Microsoft Office) in electronic document management systems and data base entry
• SAP/R3 and SAP/4HANA as user

Skills

• Excellent communication and interpersonal skills to work and collaborate in a multi-cultural environment
• Demonstrate initiative, proactivity, responsibility and work independently as well as within a team, with minimal supervision
• Self-motivated, ability to handle multiple tasks and appropriately manage priorities
• Must have excellent work habits (highly organized), quick learning skills, easy to adapt to changing scenarios

Ready to join us on our purpose to improve people's lives? Become part of a team where your passion can make a real difference.