Associate Director, Clinical QA Program Lead

hace 2 semanas

España Healthcare Businesswomen’s Association A tiempo completo

Job Description Summary
Associate Director, Clinical QA Program Lead (m/f/d)
Location: Barcelona Gran Vía, Spain #LI-Hybrid
The Associate Director, Clinical QA Program Lead will provide Quality oversight for the end-to-end clinical process for the clinical trials under responsibility to ensure compliance with the Health Authorities requirements, the internal standards and a full adherence to patients’ safety, rights and well-being.
Job Description
Major accountabilities:
Your responsibilities will be but are not limited to:

Proactively provide QA leadership to the business strategy for assigned programs/trials by ensuring considerable organization awareness (e.g. Interrelationship of departments and business priorities).
Drive implementation of quality strategy within GCT/CTT under responsibility and monitor the implementation of the annual Quality Plan pertaining to the assigned programs/studies.
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 different areas of clinical development such as collaboration with key stakeholders to ensure that risks are detected and remediated, support core governance for quality incident management for major deviations and ensure timely escalation when required, provide GCP guidance to day-to-day questions arising from Clinical trials deliverables, etc.
Support inspections preparation and facilitation, also for audits and inspections follow-up activities including CAPA preparation.
Active participation in continuous improvement initiatives (including Work streams).

Minimum requirements:

Bachelors’ degree in life science or healthcare field required. Advanced degree or equivalent education/degree in life sciences/healthcare preferred (PhD/MD/ PharmD/Masters).
Sound experience of involvement in regulated activities (GCP/PV), clinical development, and/or QA positions, as well as in project management.
Broad understanding of global expectations of Health Authorities in the area of Clinical Development and profound understanding of the science of product development.
Strong skills in GCP, quality and/or clinical development.
Ability to work independently and in a global/matrix environment.

Desirable requirements:

Prior experience in RLT strongly preferred.

Benefits & Rewards:
Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: Novartis Life Handbook
Benefits in Spain include Company Pension plan; Life and Accidental Insurance; Meals; Allowance or Canteen in the office; Flexible working hours.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and accommodation:
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in any order to receive more detailed information about essential functions of a position, please send an e-mail to inclusion.spain@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
You will receive:
Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 27 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities.
Skills Desired:
Auditing, Audit Management, Business Partnering, Clinical Development, Clinical Trials, Continued Learning, Decision Making Skills, Drug Development, Health Authorities, Influencing Skills, Inspection Preparedness, Inspection Readiness, Leadership, Product Development, Project Management, Quality Management, Quality Oversight, Quality Risk Management, Risk Management, Stakeholder Management.
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