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Commercial Qa Manager Latam

Commercial Qa Manager Latam
Empresa:

Abbott


Detalles de la oferta

This position could be located in LATAM countries, primary location Colombia.

Provide Quality Systems leadership and tactical as well as technical support to commercial affiliates in LATAM region. This position will report to the Commercial QA Manager Americas region. This position requires fluent Spanish and English speaking.

**Primary Job Responsibilities:**
The primary responsibilities include but not limited to:

+ affiliate quality system management

+ affiliate performance monitoring and risk assessment

+ affiliate training and onboarding

+ affiliate complaint handling

+ quality event evaluations

**Core Job Responsibilities:**

+ Assure that quality-related issues associated with products distributed to and from the affiliates conform to current Good Manufacturing Practices (cGMP)/Good Distribution Practices (cGDP}, Abbott Quality standards, and other applicable regulatory standards.

+ Promote sound, quality principles at Commercial Affiliates while minimizing cost increases and potential disruptions to business.

+ Understand and support AN commercial quality organization and issues.

+ Plan and implement onboarding of new Affiliate QA representatives including IT system access, Compliance Wire training curriculum.

+ Provide ongoing training to ensure compliance with identified quality goals and standards. Maintain training curriculums and matrices for affiliate QA representatives.

+ Provide overall technical and documentation support to commercial affiliates.

+ Collect, update, and monitor affiliate quality and risk metrics per AN program and support development and execution of mitigation plan.

+ Manage projects and programs as assigned by AN Management.

+ Represent the Commercial Affiliates on Cross-Region/Divisional and/or Corporate teams.

+ Act as Region technical resource regarding Quality Systems and compliance. Provide Consortium audit preparation and audit support to affiliates.

+ Support quality systems implementation and training programs as necessary for CAPA, validation, complaint registration, inspection reporting and tracking, audits, policy implementation, etc. at the affiliate sites.

+ Support on-market evaluations (include Product Action) evaluation process.

+ Coordinate Division and Plant responses to affiliate requests for information.

+ Coordinate activities between commercial sites, plants, and distribution centers as necessary to ensure policy requirements are met in respect to complaints and exceptions.

+ Integrate key initiatives (e.g., One Abbott Commercial QA) into affiliate sites as appropriate, based on compliance risk and availability of resources and business processes to support.

+ Direct and monitor affiliate Management Reviews and elevate issues to Commercial QA Manager.

+ Support affiliate complaint handling process to evaluate impact to the business and elevate as necessary.

**Position Accountability / Scope:**

+ The position reports to and is accountable to the Manager, Commercial QA Americas Region. This position is responsible for ensuring that AN commercial affiliates implement and maintain cost-effective quality system solutions and remain in compliance with regulatory requirements. Failure to meet this goal can result in AN not fulfilling the commitments of the region/division or corporate compliance plans. Financial penalties to the division, regulatory action, and/or wasted resources are possible consequences. As importantly, the quality of AN products is a competitive advantage in the market place, and any lessening of our standards can have an adverse long-term impact on our business.

**Supervisory/Management Responsibilities:**

+ Will have responsibility for 2 direct reports and approximately 13+ indirect reports (Affiliate QA).
**Minimum Education:**

+ Bachelor's Degree in a relevant scientific or business-related discipline; MBA preferred.

**Minimum Experience and Knowledge:**

+ At least 8 years in the Pharmaceutical Industry and/or Government Regulatory Agency; and at least 5 years of experience in conducting and handling audits and inspections

+ Strong knowledge of relevant regulations for quality systems and compliance

+ Knowledge of applicable regulatory standards and requirements for infant formula and Nutritionals

+ General knowledge of technical, chemical, and pharmaceutical processes, validation procedures, and analytical methodology

+ Capable of understanding and overcoming different cultural and language obstacles to provide solutions that satisfy corporate, regional, and local objectives.

+ Capable of analyzing data to support the development of strategies to effectively manage the action plans that will resolve the issues

+ Excellent verbal and written communication skills, and project management skills

+ Fluent in Spanish and English

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or e**********

Requisitos

Commercial Qa Manager Latam
Empresa:

Abbott


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