Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
Primary Job Function
Leads audits, assessments, and regulatory readiness activities across the corporation. Participate in cross-divisional activities to integrate information from compliance audits and assessments and regulatory trends that may impact Abbott Divisions.
Core Job Responsibilities
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Ensure proactive determination of regulatory, compliance, quality issues and manage to integrate them into audits, assessments, and regulatory readiness activities on a priority basis. Ensure that compliance gaps with Corporate Policies are communicated a assist with development and revisions to AQR policies by providing timely input and feedback. Identify serious compliance issues and risks so that they are understood; evaluate and provide feedback on adequacy of responses. Assist in the development and provides professional education on compliance and quality topics that are key to Abbott businesses.
Position Accountability / Scope
Effective performance of the position indirectly supports Abbott product marketing activities and management financial goals. The dollar impact on the Corporation as it relates to the incumbent's responsibility is enormous. Effective performance helps to improve product quality and prevent regulatory vulnerabilities that could result in product approval delays, product recalls or government seizure. Product quality and/or regulatory problems can negatively affect consumer health and safety, Abbott’s worldwide image, performance of Abbott earnings and market share and customer confidence and loyalty. Therefore, the regulatory accuracy and timeliness of the corporate audits is considered a first line of defense.
The position has broad responsibility that has significant impact throughout AQR and all divisions. The position is responsible for ensuring that executive management is aware of compliance business risks and regulatory requirements. The position is continually required to make technical decisions that affect product quality.
The individual must be able to work independently without direct supervision or guidance and to exercise judgment in determining when complex issues merit Corporate Management involvement. Decisions must be made based upon up-to-date technical/business knowledge and skills.
The responsibility requires very effective communication and decision making with all levels of management as well as other division and corporate departments. The incumbent must also work closely with senior management of the division when proposed changes to quality systems may have substantial impact on the operating units.
The incumbent has the authority and responsibility to direct, plan, develop and implement audit policies and programs for the systems division-wide.
Minimum Education
Four-year degree in a scientific, technical, or compliance discipline or equivalent experience (e.g., six years experience in related field).
Minimum Experience / Training Required
Individual must have excellent oral and written communication skills. Personal skills needed include tact, open-mindedness, maturity, tenacity, decisiveness, self-reliance and sound judgment. Persuasive, effective communication skills are essential with an ability to work effectively across divisional and technical areas. At least eight years in Quality Assurance or another function in the pharmaceutical, medical device, nutritional or related industry experience. Have complete knowledge of Quality Systems and Regulatory Science. One or two years in Compliance or Regulatory Affairs is desirable.
This position can bee located in the US, Spain, Germany or the Netherlands.
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