Director Distribution QA – ARDx North America

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 107,000 colleagues serve people in more than 160 countries

Director Distribution QA – ARDx North America

Orlando, FL

The Rapid Diagnostics Division at Abbott is a part of our Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies. We have an exciting opportunity for a Director Distribution QA – ARDx North America located at our Orlando, FL operations.

In this role, the incumbent will manage and develop strategies for performing detailed oversight of practices for ARDx distribution logistics for our Business Services group, as well as in overseeing the external distribution network of third party logistics providers based in North America. The responsibilities include ensuring that policies and procedures comply with guidelines set forth by all applicable regulations, both domestic and international, as well as applicable ISO (International Standardization for Organization) standards, for the distribution quality control and to meet import/export requirements as necessary.

In addition, the role directs and guides the quality and local teams in the establishment and achievement of quality objectives, including all aspects of quality system and training. Establish quality systems and plans to assure storage, handling, import/export and distribution of the highest quality products to meet agency and customer requirements. And, may interface with outside regulatory agencies including the US FDA, USDA, Health Canada and other international agencies as needed.

Also responsible for establishing, promoting and overseeing continuous improvement initiatives and coordination across ARDx distribution functions to ensure a quality mindset while supporting key business objectives are met. Directing complex cross-functional process improvements across the distribution and logistics network for ARDx, including third part logistics providers and key distributors. Works collaboratively with ARDx Global Business Services, BU Operational, Supply Chain, Quality and Regulatory functions, often interacting at multiple levels, including local and WH management and up through BU directors and DVPs as needed.

Reports on weaknesses, ineffective procedures, policy exceptions and discrepancies and recommends appropriate corrective actions to business processes, quality system procedures and guidance, and ensures compliance and quality-minded approach while making decisions to keep the customer needs as a primary focus.

The Role

• Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives
• Keeps the organization's vision and values at the forefront of decision making and action.
• Provides general direction to region directors, managers, exempt specialists and non-exempt support in various areas, groups and/or operations.
• Represents ARDx QA responsibilities and expectations to external partners, distributors and ensure our requirements are met. Where necessary, communicates effectively for needs of quality improvements and monitors progress to these plans.
• Builds strategic internal collaborations and external partnerships when needed to further organizational objectives.
• Interacts internally and externally with executive level management, outside regulatory agencies, customers, vendors and/or suppliers
• Coordinates across functional areas, business units, and/or geographies in order to achieve company or area goals.
• Utilizes technical/professional knowledge and skills to establish, interpret and execute company policies in a major segment of the company.
• Monitors and ensures compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, MOH, ISO, WHO, etc.).
• Makes and executes operational decisions with a strategic perspective.
• Directs and controls the activities and budget of functional areas as relevant.
• Establish and maintain relevant Quality Systems in compliance with regulatory requirements and meet business needs.
• Reviews, analyzes and presents to senior staff and other groups the effectiveness of the relevant Quality System elements.
• Recommends and implements changes to the system as the result of changing regulations and/or business needs.
• Analyzes data, provides recommendations to manufacturing sites, and drives decisions regarding Distribution quality related issues, nonconformances/CAPA or other potential areas of risk as identified.
• Communicates quality policies, strategies and procedures to the organization through written documents, presentations and discussions.
• Leads assigned departments by developing, communicating, and building consensus for goals and programs that support division, business unit and company objectives in a rapidly evolving division of the broader corporation.
• Creates mid- to long-range plans to carry out objectives established by ARDx management; develops and calculates a budget for one or more departments to meet organizational goals; forecasts future departmental or group needs including human and material resources and capital expenditures; determines and establishes organizational structure and supervisory relationships subject to top management approval.
• Typically makes decisions that translate programs established by ARDx management into operational plans and schedules; work is performed without appreciable direction; consequences of erroneous decisions or recommendations would normally result in failure to achieve goals critical to the major objectives of the organization and would seriously affect the financial, employment, or public relations position of the company.

Required Education and Experience:

• Bachelor’s Degree (± 12 years) in an engineering, scientific or technical discipline is required
• Minimum 10 years previous related experience required- in a Distributor Quality assurance role preferably in a medical device industry