Senior Manager Compliance of Clinical Operations & Training (m/f)

Division SANDOZ
Geschäftseinheit BioPharma SZ
Standort Holzkirchen (near Munich)
Funktionsbereich Research & Development
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 255794BR


Your Responsibilities:

• Evaluate and support development transformation initiatives
• Identify potential business process/systems deficiencies by conducting gap analysis
• Lead or participate in cross-functional teams to design, deliver and implement improvement solutions for business processes and/or technical solutions/systems
• Proactively identify analyses and leverages quality indicators and data to identify potential trends /risks to address, complete risk based assessments and to support the implementation of associated risk mitigation strategies
• Identify audit/inspection findings or process gaps/non-conformances which warrant improvement of functional processes, and support the development of solutions to maintain compliance
• Support quality issues management for aligned studies, including assessment of potential root causes and remediation (corrective and preventative actions)
• Review of study specific essential documents
• Conduct periodic internal review/assessment of Trial Master Files (TMF) to ensure compliance
• Conduct or direct internal investigation of identified compliance issues
• Conduct co-monitoring/assessment visits at investigational sites
• Conduct pre-inspection visits at investigational sites/third vendors to support inspection readiness activities
• Support functional/clinical trial teams with inspection readiness activities in collaboration with Clinical Quality Assurance
• Review audit and inspection reports to identify training needs and communicate them to those responsible for training to ensure knowledge transfer across the clinical trials/programs
• Provide guidance on regulations, GCP and other guidelines to functional/clinical trial and program teams

Research & Development


What you'll bring to the role:

• Bachelor’s degree or equivalent qualification in life science/healthcare, Master's degree is preferred
• At least 6 years clinical/industry/health authority experience, including at least 3 years with focus on quality and compliance preferred
• Thorough knowledge of Good Clinical Practice, regulatory guidelines (FDA/EMA/ICH), and clinical development process
• Ability to set global quality standards together with team
• Effective project management and team facilitation skills, excellent communication, negotiation and leadership skills
• Analytical mindset, attention to detail
• Experienced in designing or re-designing functional processes to meet quality standards and to simplify the way we work
• Fluent in English (oral and written)

Why consider Novartis?
927 million. That’s how many lives our products touched in 2017. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Sandoz, a Novartis Division. Join us and help reimagine medicine.

We develop breakthrough treatments and find new ways to deliver them to as many people as possible to improve and extend peoples’ lives. We do this, by supporting and promoting the knowledge and strengths of our employees and specifically use them to deepen our understanding of our patients and customers. Motivating conditions and an attractive salary are also part of our working environment, as well as our company culture, which is based on collaboration, curiosity, enthusiasm, courage and integrity.
Novartis stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

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