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- Aufgaben: Lead GCP Quality Management activities and ensure compliance with global regulations.
- Arbeitgeber: Join Santhera Pharmaceuticals, a leader in innovative treatments for rare neuromuscular diseases.
- Mitarbeitervorteile: Be part of a multicultural team and contribute to meaningful patient outcomes.
- Warum dieser Job: Make a real impact on patients' lives while shaping a quality culture in clinical development.
- Gewünschte Qualifikationen: Bachelor’s degree and 5-7 years in GCP Quality Management required.
- Andere Informationen: Fluency in English and relevant work permit needed; travel up to 30%.
Das voraussichtliche Gehalt liegt zwischen 72000 - 108000 € pro Jahr.
Santhera Pharmaceuticals is a Swiss specialty pharmaceutical company focused on medical science and the development and commercialization of innovative pharmaceutical products for the treatment of rare neuromuscular diseases with high unmet medical need.
Come and join our team to contribute to providing treatment options for patients with rare diseases that have a severe impact on the lives of affected children and adults. You can make a difference as:
Director GCP Quality Management
Scope of Work
We are looking for a Director GCP Quality Management to play a critical role in supporting our clinical development program and ensuring compliance with global regulations. Reporting to the Head of Quality Management, you will be a key driver in shaping and maintaining our quality culture.
In this pivotal role, you will lead GCP Quality Management activities, ensuring clinical development programs are conducted in line with regulatory requirements. You will collaborate across teams, provide expert guidance, and play a leading role in audits, risk management, and inspection readiness.
Key Responsibilities
- Design, plan, and execute risk-based GCP audit programs (internal and external).
- Provide GCP expertise to project teams and ensure Quality Management input in clinical programs.
- Lead or contribute to Quality Risk Management activities for clinical trials.
- Manage and conduct audits of internal processes, external vendors, and investigator sites to ensure compliance and identify risks.
- Oversee the development of CAPAs (Corrective and Preventive Actions) and ensure timely resolution of GCP issues.
- Establish effective communication of audit/inspection outcomes and drive continuous improvement.
- Align activities with other Quality Management functions (e.g., GVP, GMP) to ensure a cohesive approach.
- Stay ahead of emerging regulations and ensure knowledge transfer within the organization.
Required Qualifications & Experience
- Bachelor’s degree (or higher) in a relevant field.
- 5-7 years of experience in the pharmaceutical or life sciences industry, with a strong focus on GCP Quality Management.
- In-depth knowledge of FDA, EU, and ICH guidelines for clinical research.
- Proven track record managing GCP audits, health authority inspections, and inspection readiness.
- Experience in Quality Risk Management for clinical trials and implementation of quality plans.
- Knowledge of pharmacovigilance regulations is a plus.
- Excellent interpersonal and communication skills with the ability to work in a fast-paced, collaborative environment.
- Ability to travel up to 30%.
- Fluency in English (written and spoken) is required.
Required Competencies & Skills
- Strong communication and stakeholder management skills.
- Ability to work both independently and within a matrix organization.
- Strategic mindset with strong problem-solving abilities.
- Organized and detail-oriented, with excellent planning capabilities.
- Adaptability to changing priorities and deadlines.
For this position, the relevant working/residency permit or Swiss/EU-Citizenship is required.
If you are interested in a multicultural, challenging, and innovative work environment, and your profile matches our requirements, we look forward to receiving your online application in English via LinkedIn or email at
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Director GCP Quality Management Arbeitgeber: Santhera Pharmaceuticals
Kontaktperson:
Santhera Pharmaceuticals HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Director GCP Quality Management
✨Tip Number 1
Familiarize yourself with the latest FDA, EU, and ICH guidelines for clinical research. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those involved in GCP Quality Management. Engaging with them can provide insights into the company culture at Santhera Pharmaceuticals and may even lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of your experience managing GCP audits and health authority inspections. Highlighting your proven track record will set you apart from other candidates.
✨Tip Number 4
Showcase your strategic mindset and problem-solving abilities during the interview. Be ready to discuss how you've adapted to changing priorities in past roles, as this is crucial for success in a fast-paced environment like Santhera.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Director GCP Quality Management
Tipps für deine Bewerbung 🫡
Understand the Role: Take the time to thoroughly understand the responsibilities and qualifications required for the Director GCP Quality Management position. Tailor your application to highlight your relevant experience in GCP Quality Management and your understanding of regulatory compliance.
Highlight Relevant Experience: In your CV and cover letter, emphasize your 5-7 years of experience in the pharmaceutical or life sciences industry, particularly focusing on GCP audits and quality risk management. Provide specific examples of your past roles and achievements that align with the job description.
Showcase Communication Skills: Since strong communication and stakeholder management skills are crucial for this role, make sure to illustrate these abilities in your application. Use clear and concise language, and consider including examples of how you've successfully collaborated with teams or managed stakeholders in previous positions.
Proofread Your Application: Before submitting your application, carefully proofread your documents to ensure there are no grammatical errors or typos. A polished application reflects your attention to detail, which is essential for a role focused on quality management.
Wie du dich auf ein Vorstellungsgespräch bei Santhera Pharmaceuticals vorbereitest
✨Showcase Your GCP Expertise
Be prepared to discuss your in-depth knowledge of GCP guidelines and how you've applied them in previous roles. Highlight specific examples where you successfully managed audits or inspections, demonstrating your ability to ensure compliance.
✨Demonstrate Leadership Skills
As a Director, you'll need to lead teams and drive quality culture. Share experiences where you've led GCP Quality Management activities or collaborated across teams to achieve common goals, showcasing your leadership and stakeholder management skills.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities and strategic mindset. Prepare to discuss how you would handle specific challenges related to GCP audits or risk management in clinical trials, illustrating your adaptability and planning capabilities.
✨Communicate Effectively
Strong communication is key in this role. Practice articulating complex regulatory concepts clearly and concisely. Be ready to explain how you would establish effective communication of audit outcomes and drive continuous improvement within the organization.
