ABBOTT LABORATORIES Associate Director, Site Quality Assurance (QA) Salary in the United States

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 103,000 colleagues serve people in more than 160 countries.

ABOUT ABBOTT POINT OF CARE:

Abbott Point of Care (APOC) is a global leader in providing with-patient diagnostic testing solutions that are fast, portable, accurate and affordable. We are a division of Abbott, a global, diversified healthcare innovator with a legacy of pioneering work in medical diagnostics.

Our i-STAT System is an advanced, handheld system that allows medical staff to perform diagnostic testing without having to leave the patient's side. The system provides real-time, lab-quality results using only a few drops of blood and delivers accurate results in minutes rather than hours. The i-STAT System family of products and services fosters a collaborative, patient-centered environment while driving improved operational performance. Our products can play a valuable role in accelerating the patient-care decision-making process throughout the continuum of care. More than 80,000 i-STAT handhelds are used worldwide by healthcare professionals in a variety of settings.

POSITION OVERVIEW:

The Associate Director of Site Quality Assurance is responsible for the following activities:
Directing all activities within the Quality Assurance function for the single site business which include:

• Quality Assurance (Incoming Quality; Manufacturing Operations Quality)
• CAPA - Corrective Action Board; Metrics
• Materials Control – Receiving Inspection
• Management Responsibility that include Quality Management Reviews
• Auditing Product and Process Control - In-Process Inspection
• Statistical Techniques; Product Release; Validation
• Provide support and guidance in preparation of responses to Division, Corporate and external audits
• Assure compliance with all appropriate regulatory requirements
• Assist in bringing new products to market in a timely manner and within regulatory requirements

PRIMARY JOB SCOPE:

• Chief interface with regulatory agencies such as FDA.  Responsible for final product release for site. 
• This position is accountable to the DVP APOC QA for achieving mutually agreed objectives on a timely basis. 
• Decisions and recommendations made by this position have a direct impact on marketed items for domestic and international sales.
• Must effectively communicate; prepare; and negotiate both internally with APOC personnel and externally with various regulatory agencies; failure to do so will have direct impact on market entry dates and market presence for new products.
• Shutdown of production lines; which results in reduced revenues and company profits could also be a consequence of failure to manage this responsibility satisfactorily.
• Position impacts operations through GMP compliance requirements and activities such as audits, training, etc.

CORE JOB RESPONSIBILITIES:

The Associate Director, Site QA is responsible for implementing and maintaining the effectiveness of the Quality System which include:

• Responsible for continual improvement of the quality system.
• Responsible for establishing; implementing and maintaining the quality system; including quality policy; planning; the organizational structure to support the quality system; and management review of the quality system to determine its effectiveness.
• Act as the Site Management Representative. 
• Chief interface with FDA; ISO and customer entities for audits and communications. 
• Maintain the Quality Policy; planning; and the organizational structure to support the quality system. 
• Monitor and respond as required to assure the quality system is effective.
• Responsible for final product release.
• Formulates long-range objectives; plans and programs for Site Quality.
• Develops Quality Philosophies consistent with Corporate and Division Policies; and implements these within the Site.
• Develops, implements, and maintains an effective Quality data collection and information reporting systems.  Assures that these systems provide for the timely identification and reporting of product; hardware and/or software problems associated with incoming; in-process and finished product.
• Directs the analysis of product defects and recommends modifications in products or quality standards where such appear to be warranted.
• Assures that processes; products; and procedures comply with pertinent regulatory requirements and quality policy.
• Manages and motivates department personnel (including hiring; firing and evaluation of direct reports) to assure department goals; duties; and responsibilities are met and/or exceeded.
• Drives the organization for product quality and reliability awareness as well as assuring a high level of customer service.

QUALIFICATIONS:

Minimum experience required includes:

• 5 years of experience as a Quality Manager in a Medical Device (IVD preferred) environment
• 10 years of experience in GMP environment, long-range planning and facility requirements
• Up to 15% global travel

EDUCATION

• Bachelor’s Degree required in Life Science; Engineering; or Industrial Technology.
• Master’s Degree preferred in MBA or MS Engineering or MS Quality or MS Industrial Technology