Clinical quality assurance manager – São Paulo/SP
Efetivo (CLT)
Responsabilidades
- Responsible for planning and conducting Quality oversight/audit activities for veterinary Good Clinical Practice studies.
- Completes and issues audit reports, observation reports, and reviews and approves responses and corrective actions for study audits.
- Plans and executes process audits (self-inspections) of R&D internal processes.
- Provides quality oversight and compliance consultation to the R&D organization.
- Coordinates preparation activities for regulatory authority inspection of clinical investigator sites, as well as supporting these inspections.
Requisitos
- QUALIFICAÇÕES MÍNIMAS
- Master in Life Sciences or Bachelor of Science Degree in biology, animal science, pharmacy or a related field.
- A minimum of 7 years of experience in providing quality oversight or monitoring veterinary clinical and safety studies completed in support of pharmaceuticals submissions.
- Knowledge of Quality Systems and VICH Guideline 9.
- Fluency (reading and writing) in Portuguese and English.
- QUALIFICAÇÕES PREFERENCIAIS
- Proven record in delivering training to a diverse audience on compliance topics.
- Proven abilities in business partnering and influencing of scientific leaders.
Benefícios
- Monthly salary starting from R$ 15,700.
- Corporate Bonus.
- Sulamérica Health Plan.
- Sulamérica Dental Plan.
- Life Insurance.
- Meal Voucher R$ 1.000 per month.
- Food Voucher R$ 690 per month.
- Transportation Voucher or Parking.
- Day off on Birthday and on child’s birthday (up to 12 years old).
- Medication Assistance (80% discount on prescribed medications).
- Wellhub and Wellz.
- Optional Short Friday.
- Happy Hour and Dog Day at the office.
- Car Allowance.
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