Ingles-Jobs in Spanien

At STADA we pursue the purpose of "Taking care of people's health as a trusted partner." All our decisions and actions are driven by our purpose, vision and values. With our wide range of products: Generics, Consumer Healthcare and Specialties, we offer patients, doctors and pharmacists a wide range of therapeutic options.

Around 13,000 employees live our values of Integrity, Entrepreneurship, Agility and One STADA, in order to achieve our ambitious goals and shape a successful future for our company. We continually expand our goals in line with our ambition, and we achieve them with passion, commitment and a growth mindset.

Do you want to be part of a successful international pharmaceutical company and grow with us?

The Qualified Person (QP) will assume legal and regulatory responsibility for ensuring that medicinal products released for sale or distribution comply with the requirements of the Marketing Authorization (MA) or Clinical Trial Authorization (CTA) and are manufactured in compliance with Good Manufacturing Practices (GMP) and applicable regulatory standards. The role will ensure compliance with Spanish regulations established by the AEMPS and European standards outlined in Annex 16 and Annex 21 of the EU GMPs, while driving quality assurance processes and contributing to operational excellence.

1. Batch Certification and Release: Certify each batch of medicinal products, including investigational medicinal products (IMPs), before release, ensuring compliance with the requirements of the MA / CTA and EU GMPs. Verify that manufacturing and quality control activities comply with relevant GMP standards, including those at third-party Contract Manufacturing Organizations (CMOs). Ensure that quality deviations, non-conformances, and complaints are fully investigated and resolved before batch certification.
2. Compliance and Quality Oversight: Ensure compliance with the GMPs and local requirements in all the countries where the products will be commercialized. Oversee the establishment and maintenance of a robust Pharmaceutical Quality System (PQS). Lead efforts to manage and mitigate risks associated with product quality, including supply chain risks.
3. Importation and Supply Chain Oversight (Annex 21): Oversee the importation of medicinal products from outside the EU / EEA, ensuring that they meet all requirements of EU GMPs before release. Manage the importation, certification, and release of imported products, ensuring compliance with GMP guidelines.
4. Regulatory and Stakeholder Management: Act as the primary contact for the AEMPS for all QP-related responsibilities and regulatory inspections. Collaborate with internal and external stakeholders, including regulatory affairs, supply chain, manufacturing, and CMOs, to ensure alignment with quality and regulatory requirements. Ensure timely and accurate communication with authorities regarding quality incidents and recalls.
5. Audit and Inspection Readiness: Support preparation for and lead GMP audits and regulatory inspections conducted by the AEMPS, EMA, and other health authorities. Ensure the implementation of corrective and preventive actions (CAPAs) following inspections, audits, or internal quality reviews.
6. Continuous Improvement and Leadership: Drive quality improvements within the organization by fostering a culture of compliance and continuous improvement. Train and mentor staff in GMP compliance and QP responsibilities. Ensure effective knowledge transfer and training to maintain regulatory compliance across all operations.

1. A university degree in pharmacy, as required under Spanish law to act as a Director Técnico.
2. Registered as a Qualified Person (QP) in Spain under the legal requirements of the AEMPS.
3. Minimum 7-10 years of experience in pharmaceutical manufacturing, quality assurance, or a related role.
4. Proven experience as a QP certifying products for release.
5. In-depth knowledge of EU GMP guidelines, Annex 16, Annex 21, and applicable EU regulations.
6. Strong understanding of pharmaceutical manufacturing processes and quality assurance principles.
7. Excellent knowledge of GMP compliance, regulatory requirements, and risk management.
8. Demonstrated leadership, decision-making, and problem-solving abilities.
9. Effective communication and interpersonal skills, with proficiency in English.
10. Ability to work collaboratively across functional and organizational boundaries.

STADA offers a competitive environment for personal and professional development in a growing company full of opportunities. Our future project requires dynamic and proactive professionals, capable of adding value in a changing environment.