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- Aufgaben: Lead clinical programs and ensure GCP quality assurance across multiple projects.
- Arbeitgeber: Join a global leader in pharmaceutical innovation focused on quality and excellence.
- Mitarbeitervorteile: Enjoy flexible work locations and opportunities for professional growth and mentorship.
- Warum dieser Job: Be part of a dynamic team driving impactful healthcare solutions worldwide.
- Gewünschte Qualifikationen: 10+ years in quality assurance; advanced degree preferred; strong analytical skills required.
- Andere Informationen: Work remotely from various countries including the USA, UK, and Germany.
Das voraussichtliche Gehalt liegt zwischen 72000 - 108000 € pro Jahr.
Your role
The RDQRM Quality Strategy Lead Development will be mainly responsible for managing clinical programs day to day activities from GCP quality assurance perspective and delivering the full range of quality related activities in support of the program. The incumbent works closely with the project/program teams and is accountable for establishing the GCP quality assurance strategy in support of the program and to utilize/develop RDQ tools to deliver the strategy. You will lead multidisciplinary or cross-functional work/project teams and actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems. You will be responsible to lead inspection preparation activities in the cross-functional teams and partner for assigned trials/programs as part of the planned regulatory submission in different Countries/authorities (China, EU, US, Japan, etc). Strong technical expertise is a must as you will additionally lead complex projects, be involved in due diligence (DD) as GCP quality expert, and coach and mentor other colleagues in our field of Research & Development (R&D).
Who you are
- Bachelor’s degree in a relevant scientific field; advanced degree preferred.
- Minimum of 10 years of experience in quality assurance within the pharmaceutical or healthcare industry with focus on ICH GCP. Experience in medical device clinical trials is a plus.
- Experience in leading inspection readiness or inspection preparation activities. Experience in inspection management and response is a plus.
- Knowledge/ experience of due diligence processes related to asset transfer, in/ out licensing, and business development preferred.
- Proven analytical skills with a keen interest in data analysis and interpretation.
- Agile, adaptable, and curious mindset with a commitment to driving quality excellence.
- Proven ability to function autonomously at a senior level in a matrix model and in a team environment.
- Fluent in written and spoken English.
Department: HC-RD-RFSN Development Unit N&I
Job evaluation: AT – Expert 4
This position can be based in China, India, USA, Singapore, UK, Germany, Switzerland, France, Uruguay, Brazil.
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Quality Strategy Lead Development (all genders) Arbeitgeber: Merck Gruppe
Kontaktperson:
Merck Gruppe HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Quality Strategy Lead Development (all genders)
✨Tip Number 1
Make sure to highlight your experience in managing clinical programs and GCP quality assurance in your conversations. This role requires a strong understanding of these areas, so be prepared to discuss specific examples from your past work.
✨Tip Number 2
Network with professionals in the pharmaceutical and healthcare industry, especially those who have experience in quality assurance. Engaging with them can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Familiarize yourself with the regulatory submission processes in different countries, particularly China, EU, US, and Japan. Being knowledgeable about these can set you apart during discussions with our team.
✨Tip Number 4
Demonstrate your leadership skills by sharing experiences where you've led cross-functional teams or complex projects. This will show that you can thrive in a matrix model and are capable of mentoring others.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Quality Strategy Lead Development (all genders)
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the Quality Strategy Lead Development position. Highlight key responsibilities and required skills, such as GCP quality assurance and experience in leading inspection readiness activities.
Tailor Your CV: Customize your CV to reflect your relevant experience in quality assurance within the pharmaceutical or healthcare industry. Emphasize your leadership roles and any specific projects that align with the responsibilities outlined in the job description.
Craft a Compelling Cover Letter: Write a cover letter that connects your background and skills to the specific requirements of the role. Mention your analytical skills, experience with due diligence processes, and your ability to work autonomously in a matrix model.
Highlight Your Language Skills: Since fluency in English is required, ensure that your application showcases your proficiency in written and spoken English. If you have experience working in international environments, mention this to demonstrate your adaptability.
Wie du dich auf ein Vorstellungsgespräch bei Merck Gruppe vorbereitest
✨Showcase Your Technical Expertise
Make sure to highlight your strong technical background and experience in quality assurance, especially in ICH GCP. Be prepared to discuss specific projects where you applied your expertise and how it contributed to the success of clinical trials.
✨Demonstrate Leadership Skills
Since the role involves leading multidisciplinary teams, share examples of how you've successfully led cross-functional projects. Discuss your approach to coaching and mentoring colleagues, as well as how you handle inspection readiness activities.
✨Prepare for Regulatory Insights
Familiarize yourself with the regulatory environments of different countries mentioned in the job description. Be ready to discuss your experience with regulatory submissions and how you ensure compliance during inspections.
✨Emphasize Your Analytical Skills
Given the importance of data analysis in this role, prepare to talk about your analytical skills. Provide examples of how you've used data interpretation to drive quality improvements and decision-making in past projects.
