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 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 counter-parts.
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 incl. out-of-calibration results and impact.
- Assessments, manufacturing settings and recipies.
- 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 success completion of qualification and validation projects and process optimization
- Excellent language skills (English and German) both in writing and spoken
- Proven success in working a cross functional/matrix environment
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for 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 and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to 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.
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