Clinical Operational Excellence Manager (m/w)

Job description

Job Description

• Leading the harmonization of processes within the Sandoz Small Molecules (Generics) Clinical Development Teams and with the Global Drug Development processes while clearly mapping barriers to harmonization
• Leading or participating in cross-functional teams to design and implement harmonized and improved processes and systems considering the interfaces between Clinical Development and other departments
• Ensuring that procedural documents owned by Clinical Development are up-to-date and coordination or support of updating these procedural documents
• Supporting Clinical Development in audits/inspections and in the development of CAPAs
• Ensuring consistent approach/response to audit/inspection findings across clinical trials and programs as well as coordination, tracking and monitoring of the operational status of CAPA completion by Clinical Development to ensure timely close-out of CAPAs
• Developing and updating of the role-specific training matrix as well as its implementation
• Coordinating „best practice“ within Clinical Development and exchange of expertise between the Global Development teams
Position Title

Clinical Operational Excellence Manager (m/w)

Desired profile

Minimum requirements

• Bachelor`s degree or equivalent qualification in life science/healthcare, Master degree is preferred
• Fluent English (oral and written)
• Analytical mindset, quality focused and attention to details
• Good understanding of process flows
• Capability for innovation and critical thinking that challenges the status quo with new ideas
• Thorough knowledge of Good Clinical Practice, regulatory guidelines (FDA/EMA/ICH), and clinical development
• At least 10 years clinical/ industry/ health authority experience, including at least 3 years with focus on quality and compliance preferred
• Able to set global quality standards together with team
• Effective project management and team facilitation skills; excellent communications, negotiation and leadership skills
• Experienced in designing or re-designing functional processes to meet quality standards and to simplify the ways we work
• Experience of leading cross-functional teams
• Experience with developing and delivering trainings
Job Type

Full Time
Country

Germany
Work Location

Holzkirchen (near Munich)
Functional Area

Research & Development
Division

SANDOZ
Business Unit

Product Dev SZ
Employment Type

Regular
Company/Legal Entity

Hexal AG