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- Aufgaben: Lead quality assurance for external service providers in global clinical trials.
- Arbeitgeber: Join Novartis, a leader in innovative healthcare solutions.
- Mitarbeitervorteile: Enjoy a supportive work environment with personal and professional growth opportunities.
- Warum dieser Job: Make a real impact on patient lives while collaborating with passionate professionals.
- Gewünschte Qualifikationen: 12+ years in pharma development; bachelor's in Life Sciences or related field required.
- Andere Informationen: Fluent English is essential; experience with IRT and eCOA is a plus.
Das voraussichtliche Gehalt liegt zwischen 72000 - 84000 € pro Jahr.
Summary
As our Associate Director External Service Provider QA, you\’ll have the thrilling opportunity to oversee the implementation of top-notch quality standards, cutting-edge processes, and innovative tools and systems.
You will play a pivotal role in managing external service providers supporting Novartis Global Clinical Trials in R&D Quality, ensuring that our partners meet the highest standards of excellence.
About the Role
Key Responsibilities:
- Responsible for review and approval of External Service Providers (ESP) qualification for global clinical trials.
- Responsible for negotiation and execution Quality Assurance Agreements (QAA) / quality terms with ESPs.
- Review and approval of external service provider Quality Risk Assessments (QRAs) to enable identification and evaluation of various metrics, risks, trends, and potential quality and performance issues with the ESP in a proactive manner. Ensure communication and support mitigation of actions for potential risks.
- Responsible for review and approval of quality issues related to ESPs and ensure appropriate escalation of major and critical issues. Support assessment of serious breach and reporting to health authorities.
- Collaboration with business partners such as Vendor Partnership and Governance, Global Medical Affairs, other applicable Vendor Business Offices and Procurement to ensure their involvement in the risk evaluation and timely communication to the business and follow-up on required actions.
- Review quality metrics, monitoring and reporting including follow-up with line functions and escalation.
- Ensure inspection readiness of ESP related activities and support for internal and external audits and health authority (HA) inspections pertaining ESP management.
- Ensure compliance with regulatory requirements (GCP, GLP, GVP, GMP) and continuous improvement of quality relevant processes within area of responsibility.
Role Requirements:
Experience:
- 12+ years’ experience in pharmaceutical development and excellent knowledge of the quality management system, clinical operations processes and vendor management related activities is preferred.
Education:
- Minimum a bachelor’s degree in Life Sciences, Pharmacy or Medicine, or other related discipline required.
Languages:
- Fluent English (both spoken & written).
Skills & Expertise:
- Good knowledge of GCP/GLP, GMP, GVP.
- Demonstrated leadership in implementing robust processes and quality systems, and setting global quality standards in a regulated area, including controlled documentation for the pharmaceutical development area.
- Experience in managing External Service Providers and knowledge of quality standards and regulatory requirements. Experience in interactive response technology (IRT), eCOA and Imaging services is an added advantage.
- Thorough technical understanding of quality system, clinical trial process collecting, analyzing, and monitoring of Third-party Key Quality Indicators.
- Experience in data analysis and trending using available tools.
- Demonstrated effective management and establishment of successful international and cross-divisional collaborations.
- Demonstrated root cause analysis skills, stakeholder engagement and critical thinking.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up.
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally.
Job Details
Division: Development
Business Unit: Universal Hierarchy Node
Location: Germany
Site: Munich (Novartis Business Services GmbH)
Company / Legal Entity: DE61 (FCRS = DE061) Novartis Business Services GmbH
Alternative Location 1: Nuremberg (Novartis Business Services GmbH), Germany
Functional Area: Quality
Job Type: Full time
Employment Type: Regular
Shift Work: No
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability. The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.
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Associate Director ESP Quality (m/f/d) Arbeitgeber: Novartis
Kontaktperson:
Novartis HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Associate Director ESP Quality (m/f/d)
✨Tip Number 1
Make sure to highlight your extensive experience in pharmaceutical development and quality management systems during networking opportunities. Connect with professionals in the industry on platforms like LinkedIn to discuss your expertise and learn about potential openings.
✨Tip Number 2
Attend industry conferences and seminars focused on clinical operations and quality assurance. This will not only expand your knowledge but also help you meet key players in the field, which could lead to referrals or insider information about job openings.
✨Tip Number 3
Engage with online communities and forums related to GCP, GLP, and GMP. Sharing your insights and asking questions can position you as a knowledgeable candidate and may attract the attention of recruiters looking for someone with your skill set.
✨Tip Number 4
Consider reaching out directly to current employees at Novartis to learn more about the company culture and the specific expectations for the Associate Director role. This can provide you with valuable insights that you can use to tailor your approach when applying.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Associate Director ESP Quality (m/f/d)
Tipps für deine Bewerbung 🫡
Understand the Role: Take the time to thoroughly read the job description for the Associate Director ESP Quality position. Understand the key responsibilities and required skills, as this will help you tailor your application to highlight relevant experiences.
Highlight Relevant Experience: In your CV and cover letter, emphasize your 12+ years of experience in pharmaceutical development and your knowledge of quality management systems. Be specific about your past roles and how they relate to managing external service providers and ensuring compliance with regulatory requirements.
Showcase Leadership Skills: Demonstrate your leadership abilities by providing examples of how you've implemented robust processes and quality systems in previous positions. Mention any successful collaborations with cross-divisional teams or stakeholders that resulted in improved quality standards.
Tailor Your Language: Use industry-specific terminology and phrases from the job description in your application. This shows that you understand the field and are familiar with the expectations of the role, particularly regarding GCP, GLP, GMP, and vendor management.
Wie du dich auf ein Vorstellungsgespräch bei Novartis vorbereitest
✨Showcase Your Experience
With over 12 years of experience in pharmaceutical development, be prepared to discuss specific examples of how you've implemented quality management systems and managed external service providers. Highlight your leadership roles and the impact of your contributions.
✨Understand Regulatory Requirements
Familiarize yourself with GCP, GLP, GMP, and GVP regulations. Be ready to explain how you have ensured compliance in previous roles and how you would approach maintaining these standards at Novartis.
✨Demonstrate Collaboration Skills
Since the role involves working with various business partners, prepare to share examples of successful collaborations. Discuss how you’ve engaged stakeholders and navigated cross-divisional projects to achieve common goals.
✨Prepare for Quality Metrics Discussion
Be ready to talk about your experience with quality metrics, risk assessments, and data analysis. Think of specific instances where you identified trends or issues and how you addressed them proactively.
