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Job Information


Primary Job Function

As an experienced resource, function is responsible for leading continuous improvement initiatives, global quality projects, compliance initiatives, risk assessments and remediation activities involving various areas under scope of responsibility. This role requires vast experience in Quality Systems and GMP compliance, and the ability to apply this knowledge to all manufacturing sites across EPD. The job also requires the ability to share the knowledge and influence other’s organization into compliance. The position can be based in Chile, Argentina, Colombia or Puerto Rico.

Core Job Responsibilities

• Provides inspection readiness support to EPD locations, as applicable, through the identification of compliance gaps and risks, and participation in the remediation process.

• Provides on-site support during regulatory inspection, as applicable, as Front or Back Room resource and Division scribe.

• As part of the Global Compliance team, supports EPD Compliance Program during coordination and execution of on-site compliance assessments and the identification of remediation plans. This includes both Compliance and Data Integrity assessments.

• Provides divisional oversight on key remediation activities resulting from Division internal audits, to ensure timely and comprehensive completion.

• Develops and implements Division wide compliance initiative and interacts with Regional QA Directors and QA Heads representing Divisional QA. Will also represent Division in Corporate driven initiatives.

• Assess the appropriateness and timeliness of proposed CAPAs, and track CAPA follow-up to close.

• Reads and extracts developing regulations and trends from available sources to provide recent perspectives during audits. Ensure a proactive determination of regulatory, compliance and quality issues and integrates them into audits/assessments on a priority basis.

• Responsible for communication and documentation of internal and external compliance related information. Includes changes in regulations, new guidelines and guidance documents from regulatory authorities and trade organizations.

• Responsible for leading continuous improvement initiatives including creation, scoping and implementation.

• Manages assigned global quality projects and compliance initiatives.

• Trains employees on areas of expertise, as requested

Position Accountability / Scope

The Manager Quality Assurance works with guidance from the Director of Global Audit and Compliance. This position partners with Operations, Contract QA, Development, Purchasing and Supply Chain to ensure GxP compliance globally in EPD sites.

Minimum Education

Bachelor Degree or equivalent level of education in a relevant scientific/ technical discipline such as Chemistry, Pharmacy, Biology, Microbiology, Engineering or industry experience with sufficient exposure to pharmaceutical industry is a must.

Minimum Experience/ Knowledge Required

• 7-10 year experience in pharmaceutical Industry or government regulatory agency and at least 5 years of GxP experience with responsibility for managing the quality system

• Experience in conducting and handling audits and inspections

• Strong knowledge of relevant regulations for quality systems and compliance, including Data Integrity regulations.

• 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 analysing 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.

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 email