Regional Compliance Manager Latam - Rio de Janeiro, Brasil - Abbott Laboratories

Abbott Laboratories

Empresa verificada

Rio de Janeiro, Brasil

há 2 semanas

Postado por:

Ana Silva

beBee Recruiter

Descrição

About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life.

You will have access to:

Career development with an international company where you can grow the career you dream of.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Rio de Janeiro-Brazil, Chile, Colombia, Mexico, or Peru location in the Established Pharmaceutical Division.

We are committed to bringing the benefits of our trusted medicines to more people in the world's fastest-growing countries.

Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.

As the Regional Compliance Manager, you will be responsible for leading continuous improvement initiatives, compliance initiatives, audit readiness initiatives, and risk assessments involving various areas under the scope of responsibility, including but not limited to Latin America Abbott manufacturing sites and new acquisitions.

What You'll Do

Manages assigned regional quality projects and compliance initiatives and provides support for the implementation of compliancerelated initiatives within the Established Pharmaceutical Latin America manufacturing sites.
Provides inspection readiness support to Established Pharmaceutical Latin America locations, as applicable, through the identification of compliance gaps and risks, and participation in the remediation process. Acts as Subject Matter Expert for Audit in Internal and External Audits.
Work with the Division to support and implement in the region compliancerelated initiatives.
Monitors internal audits in all LATAM sites and performs audits/assessments in preparation for audits.
Assess the appropriateness and timeliness of proposed CAPAs, and track CAPA followup to closure.
Check effectiveness in CAPA process.
Maintain an excellent understanding of actual and future regulatory expectations and provide support for compliance inside the region and sites.
Support sites with problem resolution of quality related issues with onsite visits as defined by the criticality of the issue and overall impact on product and deliverables.
Provide support for external regulatory audits / preapproval inspections and readiness for inspections.
Provides general direction to local Compliance Managers, Quality System, and Quality Assurance managers.
Monitors and ensures compliance with company policies and procedures and local regulations.
Identify critical points for improvements and assure reduce risks in future audits.
Manages key QMS Projects that drive improvements in process efficiencies and effectiveness while assuring regulatory compliance.
Reports on weaknesses, ineffective procedures, policy exceptions, and discrepancies and recommends appropriate corrective actions.

Required Qualifications

Bachelor's degree in Science related fields such as Pharmacists, Chemist, or Engineer.
Fluent in both: English and Spanish
5+ years of significant experience in quality related experience in Pharmaceutical industries including audits, CAPA Processes, and Quality Systems.
Strong communication skills
Experience working with manufacturing sites is required.
Technical expertise and knowledge gained through experience are crucial elements for success in chemical and pharmaceutical processes, Validation experience, and Risk Management concepts.
Experience in conducting and handling audits and inspections
Strong knowledge of relevant regulations for quality systems and compliance
Ability to effectively interact, manage, motivate, and influence internal and external business partners.
Experience in Microsoft tools (Excel, PowerPoint, Word, etc.)
Requires international travel based on business needs Up to 5060%

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.

Abbott is an Equal Opportunity Employer, committed to employee diversity.