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Associate Director Clinical QA
hace 4 meses
6.2million That’s the number of patients we reached through access-to-medicine approaches in 2021.
- We have received more product approvals in the past 12 years in the US and EU than any other healthcare company, and 21+ breakthrough therapy designations from the FDA. Today we reach almost a tenth of the world’s population.
- Be part of a dedicated, passionate team in a role where you are encouraged to create innovative solutions for Clinical Quality Assurance team who are specialized in the area of Global Drug Development (GDD), leading the way for Novartis’ innovative medicines.
- As Associate Director Clinical QA Program Lead you will provide strategic Quality oversight on the entire Clinical Trial Process (CTP). This includes the clinical trials under your responsibility, you will ensure compliance with the Health Authorities requirements, the internal standards and a full adherence to patients’ safety, rights and well-being.
- The Associate Director will use their expertise in the field, risk analysis and decisive problem-solving mindset to take critical decisions together with internal stakeholders, ensuring clinical trials have no delays whilst maintaining high quality level data.
- This role is fundamental in dispensing QA expertise and guidance to the Global Clinical Teams (GCT) and collaborating with other QA functions in order to ensure that high priority programs, Quality initiatives driven by the business meet defined expectations. In this high-visibility role, you will take full ownership of the quality aspects of the assigned clinical trials Lead/ participate in due diligence efforts for assigned programs. Using excellent communication and interpersonal skills the Associate Director will drive a culture of quality in GDD by close business collaborating to positively impact the business and implementing the Strategy, Mission and Vision of Global Development QA (GDQ).**Your responsibilities include, but not limited to**:
- Proactively provide QA leadership to the business
strategy for assigned trials by ensuring considerable
- organization awareness (e.g. Interrelationship of
- departments and business priorities)- Support implementation of quality strategy within
GCT under responsibility.- Regularly monitor the implementation of the annual
Quality Plan pertaining to the Clinical chapter and
- ensure that all delayed activities have a documented
- rational and appropriate escalation.- Ensure adequate oversight of proactive quality risk
management process in the overseen areas
- including quality risk assessments and
- submission/inspection readiness activities and
- ensure that CTP processes are in control- Provide robust and clear quality oversight in the
following areas of clinical development by- Proactively support / collaborate with key
stakeholders (ai CPO QA, Franchises/DU’s, GPT) to
- ensure that risks are detected and remediated prior
- to allocating critical trials (as determined) to sites.- Establish/ lead core governance for
deviation/incident management for critical or major
- deviations pertinent to the programs being assigned
- and ensure timely escalation when required
Provide regulatory guidance to day to day questions
- arising from Clinical trials deliverables- Collaborate with Development Operations QA to
drive initiatives relevant to internal monitoring and
- outsourced activities Quality oversight- Support inspections preparation and facilitation in
collaboration with other QA groups including but not
- limited to CPO QA, compliance and GCA.- Participate in audits and inspections follow-up
activities including CAPA preparation g. In
- collaboration with other QA functions, provide
- lessons learned from deviations/incidents, audits
- and inspections.- Actively leverage audit/inspection outcomes/trends
to sustain improvement in clinical trials conduct.- Support continuous improvement initiatives
(including Work streams) and ensure that areas
- identified as weaknesses are properly being
- addressed and executed for sustainability 8. Be QA
- point of contact for the defined trials and attend the
- meetings and ensure quality is embedded in the
- decision taking processes.**Commitment to Diversity & Inclusion**:
- Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve._
**Minimum requirements**
- Degree in Life Sciences, Pharmacy or Medicines.
- Fluency in English (oral and written)
Experience/Professional requirement:
- 7 years’+ of involvement in regulated activities
(GCP/PV), clinical development and/or QA positions
and 3+ years’ experience in managing projects.
- 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.
- Ability to effectively interact with and pre
