Clinical Operational Excellence Manager (m/w) - SANDOZ - Holzkirchen - Wizbii

Clinical Operational Excellence Manager (m/w)

  • Durch SANDOZ
  • Unbefristeter vertrag
  • Holzkirchen (Germany)
  • Qualität / Sicherheit / Hygiene

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)

Seeked 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
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About SANDOZ

Sandoz, une division de Novartis, est un leader mondial parmi les fabricants de médicaments génériques. Sandoz (26400 collaborateurs répartis parmi 130 pays avec un CA de 9.6 milliards USD en 2014) met à disposition des patients et des professionnels de santé des médicaments de qualité dont les prix maitrisés facilitent l’accès aux soins et contribuent à l’optimisation des dépenses de santé. Sandoz France fonde son développement sur la confiance des patients, de ses clients, de ses partenaires et appuie son succès sur : une recherche permanente de l’innovation, tant pour ses produits (génériques et biosimilaires) que pour ses actions ; Un portefeuille large, qui inclut une offre croissante de biosimilaires et qui répond aux besoins essentiels de santé publique ; Le savoir-faire industriel du Groupe Novartis, et de plus de 40 partenaires français ; L’engagement d’équipes fières et responsables, réunies autour d’une vision commune et de valeurs partagées.

No vacancies open at SANDOZ

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