Bachelor's degree in Engineering end equivalent related work experience.
Solid experience in a pharmaceutical research/manufacturing quality organization. Previous departmental experience required.
English Fluent and Spanish Fluent.
Experience with pharmaceutical industry quality certifications (CRO, GCP, MR e PSP).
Researches, creates, and aligns quality initiatives with current regulatory bodies requirements as a function of the scope of work .
Decisions made with in-depth understanding and interpretation of procedures, company policies and business practices to achieve general results.
Responsible for setting department deadlines.
Responsible for all contractual agreement aspects (MSA, QA, SLA) where regulated GxP quality and/or quality of service provided is stipulated.
Ability to comprehend, analyze, and interpret the most complex business documents.
Ability to respond effectively to the most sensitive issues. Ability to write reports, manuals, speeches and articles using distinctive style.
Ability to make effective and persuasive presentations on complex topics to employees, clients, top management and/or public groups.
Ability to forecast and prepare budgets. Conducts financial/business analysis including the preparation of reports.
This role is responsible for the delivery of all quality and compliance deliverables for regulated and non-regulated services provided to the client; per the master service agreement, quality agreement, and any local service level agreements.
Responsible for the implementation of the Quality System, focused on meeting GMP, GCP, GPVP, GDP and GAMP requirements, internal and external audits - including PSP and MR - and on CROs and investigative sites, in addition to managing regulatory inspections.
- Assistência médica
- Assistência odontológica