Auf einen Blick
- Aufgaben: Lead qualification projects and ensure timely completion while managing stakeholder relationships.
- Arbeitgeber: Join ClinChoice, a global CRO dedicated to quality and professional development in the pharmaceutical industry.
- Mitarbeitervorteile: Enjoy a supportive culture with opportunities for career growth and continuous training.
- Warum dieser Job: Be part of a mission-driven team that contributes to innovative drug development and a healthier world.
- Gewünschte Qualifikationen: 5+ years in GMP/pharmaceuticals, excellent English and German skills, and experience in cross-functional environments.
- Andere Informationen: This is an office-based role in Ludwigshafen, Germany, until September 2025.
Das voraussichtliche Gehalt liegt zwischen 48000 - 84000 € pro Jahr.
Qualification and Validation Manager
at ClinChoice (View all jobs)
Ludwigshafen, Germany
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds.
ClinChoice is searching for a Qualification & Validation Manager to join one of our partner companies, a large pharmaceutical company in Germany. This is an office-based role in Ludwigshafen, Germany. It is 1 FTE, until the end of September 2025.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and a supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counterparts.
Main Job Tasks and Responsibilities:
- Planning, driving, and assuring the on-time completion of qualification projects, keeping validation master plans actual, stakeholder management.
- Review and approval of changes, calibrations including out-of-calibration results and impact.
- Assessments, manufacturing settings, and recipes.
- Optimization of the local procedures in alignment with the global processes.
- Optimization of the local templates (e.g., URS, IQ/OQ/PQ-plans, etc.).
- Demonstrate a high degree of soft/presentation skills.
- Ability to ‘coach others’ and ‘be coached’ (by peers, management, and partners).
Education and Experience:
- 5+ years of experience in GMP/pharmaceutical industry or medical devices regarding qualification and validation of computerized lab and production equipment.
- Proven successful completion of qualification and validation projects and process optimization.
- Excellent language skills (English and German) both in writing and spoken.
- Proven success in working in a cross-functional/matrix environment.
The Application Process
Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built. Close management and training are the core instruments to develop and maintain highly-qualified personnel. Continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
Key words: Qualification Manager, Validation Manager, Regulatory, Laboratory, GMP, Calibration, German, English, CRO, Contract Research Organization, Outsourced, Outsourcing, Sponsor-dedicated.#J-18808-Ljbffr
Qualification and Validation Manager Arbeitgeber: ClinChoice
Kontaktperson:
ClinChoice HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Qualification and Validation Manager
✨Tip Number 1
Fokussiere dich auf deine Erfahrungen in der GMP- und pharmazeutischen Industrie. Bereite konkrete Beispiele vor, die deine Erfolge bei der Durchführung von Qualifikations- und Validierungsprojekten zeigen. Dies wird dir helfen, im Gespräch zu überzeugen.
✨Tip Number 2
Da die Rolle client-facing ist, solltest du deine Kommunikationsfähigkeiten betonen. Übe, wie du komplexe technische Informationen klar und verständlich präsentieren kannst, um Vertrauen bei den Kunden aufzubauen.
✨Tip Number 3
Nutze dein Netzwerk, um mehr über die Unternehmenskultur von ClinChoice zu erfahren. Verbindungen zu aktuellen oder ehemaligen Mitarbeitern können dir wertvolle Einblicke geben, die dir helfen, dich besser auf das Interview vorzubereiten.
✨Tip Number 4
Bereite dich darauf vor, Fragen zur Optimierung von Prozessen zu beantworten. Überlege dir spezifische Strategien oder Methoden, die du in der Vergangenheit angewendet hast, um lokale Verfahren an globale Standards anzupassen.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Qualification and Validation Manager
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the Qualification and Validation Manager position. Understand the key responsibilities and required qualifications, so you can tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasize your 5+ years of experience in the GMP/pharmaceutical industry. Provide specific examples of successful qualification and validation projects you've completed, as well as any process optimization you've achieved.
Showcase Language Skills: Since excellent language skills in both English and German are required, make sure to highlight your proficiency in both languages. If applicable, mention any relevant certifications or experiences that demonstrate your language capabilities.
Demonstrate Soft Skills: The role requires strong soft and presentation skills. In your application, provide examples of how you've effectively communicated with clients or coached others in a professional setting. This will help illustrate your ability to establish a high-trust environment.
Wie du dich auf ein Vorstellungsgespräch bei ClinChoice vorbereitest
✨Showcase Your Experience
Make sure to highlight your 5+ years of experience in the GMP/pharmaceutical industry. Be prepared to discuss specific qualification and validation projects you've successfully completed, as well as any process optimizations you've implemented.
✨Demonstrate Soft Skills
Since this role requires a high degree of soft and presentation skills, practice articulating your thoughts clearly and confidently. Think of examples where you've effectively communicated with clients or coached others, as these will be valuable during the interview.
✨Prepare for Technical Questions
Expect questions related to qualification projects, validation master plans, and stakeholder management. Brush up on your knowledge of URS, IQ/OQ/PQ plans, and calibration processes to demonstrate your technical expertise.
✨Cultural Fit and Values
ClinChoice values diversity and inclusivity, so be ready to discuss how your background and experiences align with their mission. Share examples that reflect your commitment to quality and professional development, as well as your ability to work in a cross-functional environment.