Become part of our talent pool for future Qualified Persons (QPs) / Knowledgeable Persons (all genders)

Role Summary

Thank you for your interest in a career at AbbVie Germany! Although we are not currently actively recruiting for this position, we are happy to connect with qualified candidates who are interested in potential future Qualified Person (QP) positions. By applying to this pipeline, you will become part of our talent pool and will therefore be the first to be informed as soon as suitable vacancies are advertised.

Our contribution for you

• a varied area of activity in which you can really make a difference
• an open corporate culture
• an attractive remuneration
• intensive training by a mentor
• flexible working time models for a healthy work-life balance
• Company health management with comprehensive health and sports programs
• company social benefits
• diverse career options in an international company
• Attractive development opportunities at a high level
• a strong international network

At AbbVie you will find a workplace where your individual commitment counts so that we can achieve great things together. Be there and grow with us – always beyond yourself!

Requirements

What awaits you

As a qualified person (qualified person according to Section 15 AMG, Annex 16 EU Directive and AMWHV), you take on a central role in pharmaceutical quality assurance and support the production, testing and approval of medical products. You are responsible for evaluation and batch releases either in Research & Development (Clinical Investigational Products) or in Operations (Drug Product / Finished Goods). You ensure that all statutory and AbbVie internal quality standards are met and contribute to providing safe and effective medicines for patients.

• Become part of our team of experts and provide significant impetus for quality and progress!
• Exercising the function as a qualified person (QP) / competent person in accordance with legal and regulatory requirements (e.g. AMG, AMWHV, EU GMP guidelines, CTR No 536/2014)
• Release and certification of AbbVie products
• Ensuring compliance with regulatory requirements, compliance with IND/IMPD submissions and product quality/safety
• Processing and approval of deviations including root cause identification, pharmaceutical assessment and determination of CAPA measures
• Creation, evaluation and review of general GMP documents and quality-relevant contracts (e.g. QTAs)

Participation in quality assurance contracts (TQA) between Abbvie and partner companies, acquisitions, contract manufacturers, contract auditors, other service providers and other AbbVie units and branches, including ensuring adherence to the contract contents and compliance

What you should bring with you

• Completed studies in pharmacy and license to practice medicine
• Expertise according to §15 AMG and qualification for recognition as a QP
• At least 5 years of professional experience in the pharmaceutical industry in the area of manufacturing or quality
• Very good knowledge of GMP (D, EU, US) and international pharmaceutical law
• Very good written and spoken German and English skills (C1 level)
• Strong analytical thinking skills and the ability to systematically analyze complex situations and identify and solve problems efficiently
• High level of initiative, motivation and team-oriented working style as well as intercultural and cross-departmental collaboration and network-oriented work with external partners (authorities, customers, partners)
• Basic knowledge of project management

Benefits

Only together can we achieve the best for patients. That's why we at AbbVie focus on equal opportunities, diversity & inclusion. We create a working environment in which all employees can develop their potential - regardless of gender, origin, religion, sexual orientation or other dimensions of diversity.

• But for us, diversity means more than just taking obvious differences into account: it also refers to different educational backgrounds, specialist knowledge, personality types, ways of thinking and life experiences.
• AbbVie is an equal opportunity employer and committed to operating with integrity, driving innovation, changing lives and serving our community. Equal Opportunity Employer/Veteran/Disabled.

About the Company

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.