Your Key Responsibilities
- Define Sandoz Technical Development Quality Strategy with a key focus on both Small Molecules and Biosimilars development activities.
- Drive continuous improvement by contributing to Strategic Quality Planning and Risk Management e.g. via Quality/ Data Integrity Plan
- Ensure QA Compliance to applicable regulatory requirements for both Small Molecules and Biosimilars Product and Analytical Development activities both in-house and externally
- Drive quality integration of new parts of the SGD organization, especially in the course of building up Sandoz’ inhouse development capabilities in the area of Biosimilars (e.g. new in-house development center, acquisition of new SDC sites, …)
- Establish adequate governance mechanisms to monitor QA compliance of development activities, define and implement CAPAs in case of deviations
- Establish and drive compliance remediation programs in case major needs for improvement are identified
- Support major acquisition projects, due diligence activities and organizational changes to ensure QA compliance at any time
- Manage the resolution of GMP issues and significant deviations and investigations. Ensure senior management is notified of significant GMP events through the escalation process,
- Ensure continuous inspection readiness and timely implementation of CAPA plans, supporting/supervising the communication to Health Authorities linked to all product and analytical development activities of Sandoz
- Own inspection and audit preparation incl. the follow-up in particular for PAI and Mock-PAIs e.g. thru on-site support, compliance assessments and site visits upfront
- See the bigger picture and drive pro-active compliance and sustainable operational efficiency as contribution to project success (Gx mindset)
- Work with the business functions to develop KQIs that guide business decisions
- Define and report KQIs/KPIs for Technical Development Quality network
- Ensure and provide guidance on Data Integrity and eCompliance
- Lead a team of SDC QA Heads in various locations around the globe within Sandoz Global Development.
- Ensure adequate staffing, technical competence and skill set as well as drive organizational and people development in all areas of responsibility.
- Ensure the definition of clear targets and objectives for all team members.
- Ensure regular Quality Management Reviews in all major parts of the organisation and define corrective and preventative measures in case required
- Identify resource and skill gaps, subsequently:
- Recruit staff as required
- Support the team in their personal development and in determining training needs
- Strive to consistently uphold Sandoz´s core values
- Execute other duties as required by the Operational and/ or Functional Supervisor
- Adhere to Sandoz values and behaviours in line with the generic mindset and Sandoz company culture
Your Key Responsibilities
Technical project governance & compliance:
- Define Sandoz Technical Development Quality Strategy with a key focus on both Small Molecules and Biosimilars development activities.
- Drive continuous improvement by contributing to Strategic Quality Planning and Risk Management e.g. via Quality/ Data Integrity Plan
- Ensure QA Compliance to applicable regulatory requirements for both Small Molecules and Biosimilars Product and
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Head Technical Development Quality Bio & Small Molecules (m/w/d) in Holzkirchen Arbeitgeber: Sandoz in Deutschland
Sandoz ist ein hervorragender Arbeitgeber, der eine offene und kollaborative Unternehmenskultur fördert, in der Vielfalt und individuelle Weiterentwicklung geschätzt werden. Mit einem agilen Arbeitsumfeld und vielfältigen Entwicklungsmöglichkeiten bietet Sandoz nicht nur die Chance, an der Gestaltung einer gerechteren Gesundheitsversorgung mitzuwirken, sondern auch die Möglichkeit, sich persönlich und beruflich weiterzuentwickeln. Die Position des Laborleiters in der Qualitätskontrolle am Standort ermöglicht es Ihnen, aktiv zur Verbesserung von Prozessen und zur Sicherstellung höchster Qualitätsstandards beizutragen.
