Manager Compliance of Clinical Operations & Training (d/f/m)
|Standort||Holzkirchen (near Munich)|
|Funktionsbereich||Research & Development|
|Art der Stelle||Vollzeit|
8 biosimilars across immunology, oncology and endocrinology are already on the market, and Sandoz Biopharmaceuticals has a leading biosimilars pipeline with additional molecules in various stages of development. As Laboratory Head Bioanalytics you are responsible for providing high quality analytical data and expertise to contribute to the future success of our biosimilars development.
Support Biopharmaceutical Clinical Development (BCD) objectives in meeting quality and compliance by identifying and implementing process improvement through performing analysis of audit/inspection results; conducting activities related to compliance/inspection readiness and providing guidance to the functional/clinical trial teams in developing corrective and preventive actions plan (CAPA) and tracking/monitoring of CAPA status to ensure implementation and close-out of CAPA.
• Coordinate and support functional/clinical trial teams in audit/inspection activities in close collaboration with Clinical Quality Assurance
• Work with functional/clinical trial teams to ensure consistent approach/response to audit and inspection findings across clinical trials and programs
• Identify audit/inspection findings or process-gaps/non-conformances which warrant improvement of functional processes, and support the development of solutions to maintain compliance
• Provide guidance to cross functional clinical trial teams and participate in the root-cause analysis to develop CAPA to address audit/inspection findings
• Regularly review processes in collaboration with line function heads to ensure effectiveness and efficiency of processes, and compliance with regulations, guidelines, Novartis Quality Modules and Policies
• Regularly conduct Trial Master File (TMF) Quality Checks
• Conduct Site/CRO assessment visits
• Track and follow-up on activities resulting from the TMF Quality checks and assessment visits in collaboration with cross functional clinical trial teams
• Regularly review study specific plans and manuals to ensure effectiveness, efficiency and compliance to the internal processes across clinical trials and programs
What you’ll bring to the role:
• Bachelor’s Degree or equivalent qualification in life science/healthcare, Master degree is preferred
• Fluent English (oral and written)
• Thorough knowledge of Good Clinical Practice, regulatory guideline (FDA/EMA/ICH) and clinical development process
• At least 7 years clinical/industry/health authority experience, including at least 3 years with focus on quality and compliance preferred
• Solid knowledge in terms of clinical trials conduct under GCP landscape
• Able to set global quality standards together with teams
• Solid experience in inspections (e.g. FDA, EMEA) and audits
• Analytical mindset, attention to details
• Effective project management and team facilitation skills
Why consider Sandoz?
Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.
Join us, and help reimagine access to medicine.
Sandoz 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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