Head Compliance of Clinical Operations & Training (CCOT) (m/f)

SANDOZ
Division SANDOZ
Geschäftseinheit BioPharma SZ
Standort Oberhaching (bei München)
Funktionsbereich Research & Development
Art der Stelle Vollzeit
Anstellungsverhältnis Unbefristet
StellenID 253929BR


Stellenbeschreibung

Head Compliance of Clinical Operations & Training (CCOT) is responsible for leading the CCOT team, managing cross-functional initiatives and activities with the BCD transformation process. Contribute to increase performance and to ensure compliance within Clinical Operations. Establish close working relationships across all functions in Clinical Operations, BCD, as well as corresponding Global Drug Development (GDD) functions and foster global interfaces.

• Lead, manage and support cross-functional teams to design, deliver and implement improvements for business processes, teams, interfaces and training in-line with development strategies/goals
• Identify proactively business needs and help create innovative solutions that deliver lasting value to Clinical Operations
• Ensure project plans and methodologies are simple, timely and deliver fit for purpose solutions
• Develop and manage line reports, drive local talent management, competency needs and performance standards and act as mentor as needed
• Develop training plans/modules for Clinical Operations team in collaboration with group heads and team leads to build competencies and skills
• Contribute to the development of Clinical Operations strategy, goals and standards
• Ensure all processes owned by Clinical Operations (GOPs, SOPs, WIs, BGs, etc.) are up-to-date in accordance with current practices and regulatory requirements
• Monitor trials, service providers and Clinical Operations performance through KPI measurement
• Work with other functional heads in Clinical Operations to optimize team and CRO performance
• Together with Quality Assurance department, support teams in inspection readiness activities, during inspections or audits as well as in all follow-up activities including CAPA preparation.



Research & Development


Mindestanforderungen

• Master’s Degree/PhD plus 7 years or Bachelor`s degree plus 9 years experience in pharmaceutical business including relevant leadership positions preferred
• Fluent English (oral and written)
• Experience of leading cross-functional team to deliver business improvement, cultural change or learning solutions
• Capability for innovation and critical thinking that challenges the status quo with new ideas to create business value
• Solid knowledge of drug development (specifically in clinical trials), commercialization and related processes
• Fundamental experience in inspections (e.g. FDA, EMEA) and audits
• Good understanding of business improvement methodologies, consulting techniques, innovation and learning solutions
• Good people management and mentoring skills
• Excellent communication, presentation and interpersonal skills


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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