Senior Manager Clinical Development QA – Biosimilar Programs (m/f)

Division Global Drug Development
Geschäftseinheit QA GDD
Standort Oberhaching (near Munich)
Funktionsbereich Quality
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 253311BR


Stellenbeschreibung

• Implement the Novartis quality strategy within CTT/ICT/GPT under responsibility, as assigned.
• Proactively oversee the Clinical Quality Risk Management process and submission/inspection readiness activities and ensure that processes are under control.
• Provide robust quality oversight in the following areas of clinical development:
- Proactively support / collaborate with key stakeholders to ensure that risks are identified, regularly reviewed, communicated and controlled.
- Support deviation/incident management for deviations pertinent to the programs being assigned and collaborate with other QA teams and business to drive continuous improvement.
- Provide regulatory intelligence guidance to day to day questions arising from Clinical trials deliverables
- Participate in review and approval of key Clinical Study documents (e.g., Study Protocols, Monitoring Plans and Clinical Study Reports).
- Collaborate with other QA functions and business to drive outsourced activities
- Support inspection management (preparation, hosting, follow-up) in collaboration with other QA groups and business functions.
- Support audit planning, management and follow-up.
• As assigned, and as designate, represent CQA Biosimilar Programs and attend governance leadership meetings for Quality discussions to support the QRB meetings.
• Identify and lead continuous improvement initiatives (including work streams) and ensure that areas identified as weaknesses are properly being addressed and executed for sustainability.
• Support GOP/SOP review, as assigned, as well as support GCP training as assigned.
• Support development and implementation of Quality Management Systems at global and local level, as applicable.
• Manage a team of Clinical Development QA managers/associates and ensure one aligned approach is taken for implementing a pro-active CQA approach in support of Biosimilar trials, if assigned.



Quality


Mindestanforderungen

• Bachelor Degree in Life Sciences, Pharmacy or Medicines
• Fluent in English, knowledge of other languages (e.g., German) a plus but not required
• Minimum 6 years of experience in regulated activities (GCP/PV), clinical development and/or QA positions.
• Broad understanding of global expectations of Health Authorities in the area of Clinical Development and profound understanding of the science of product development.
• Ability to work independently and in a global/matrix environment.
• Two or more years’ experience in managing projects.
• Ability to effectively interact with and present to senior management, as well as to external audiences and inspectors.
• Strong skills in GCP, quality and/or clinical development. Experience in Late Phase Clinical Development desirable.
• Experience with managing Authority inspections desirable.
• Auditing Experience desirable
• Strong interpersonal, communication, negotiation, and problem solving 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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