GENERAL SUMMARY & OVERALL CHALLENGES
General Profile - First-level manager who provides technical and managerial guidance to subordinate supervisors or highly skilled individual contributors.
Accountability and impact - Ensures projects are completed on time within budget and leads the development of processes and procedures to implement functional strategies.
Decisions and results have a considerable mid - term impact on department operations and resources in the mid-term. Meet regulatory requirements and establish policies and procedures.
Problem Solving and Innovation - Resolves operational problems though collaboration with other manager and coordinates assets to meet operational objectives within own area.
Working Relationships - Frequently interaction with heads of other main departments of the Selling Unit as General Manager, Finance, Human Resource, Legal, Operation and Technical Assistance. Direct contact with Business Units/Manufacturing Sites and other Selling Units.
KEY RESPONSIBILITIES
Responsible for continuous improvement, adequacy and efficiency of Brazil QMS. Leads all aspects of the implementation of an effective CAPA program to prevent reoccurrence or occurrence of quality problems.
Certifies that the company meets all the license requirements to keep the importation and distribution activities, assure the validity of the licenses over the time. Assures compliance by keeping track of the time of renewal (involving all the required areas to advance successful in the process).
Assist Business Units with international audits as MDSAP and MAPSS.
Support and guide the marketing strategy of the company.
Assist on the development of products to meet the regulatory rules and requirements.
Responsible for registering new & market expansion products in whole Latin America, as well as renewal of the current registrations in order to assure continuous supply of products.
Responsible for Regulatory Intelligence of Latin America countries, assuring continuos compliance with regulations from different Health Agencies.
Responsible for distributor channel in Latin America as well as all activities under their responsibility related to RAQA.
REQUIREMENTS FOR THIS POSITION
**Professional Experience**: Strong experience in RAQA in Latin America.
**Education**: Bachelor's degree in life science (e.g.: pharmacy, biochemistry, etc). Active bachelor’s degree to assume the technical responsibility of the company is required. Master’s degree in Administration is recommended.
**Language**: Advanced English and Spanish
**Trip**: 30%
KEY RELATIONSHIPS
**Internal**: Reports into the Global Registration Team Structure. Partner of the Selling Unit.
**External**: Clients, Distributors, Government Officers and Certification Bodies.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
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