QA Director, Commercial and Affiliate

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 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Job Title

QA Director, Commercial and Affiliate

The Opportunity

The QA Director, Commercial and Affiliate will develop, establish and maintain operational quality assurance programs, policies, processes, procedures and controls ensuring that the organization conforms to established standards and agency regulations. This position can work out of any AVD Vascular Division location.

What You’ll Work On

• Define and communicate overall vision and cascaded objectives for the departments.
• Provides overall leadership for Quality policies, approaches, and standard practices. Maintains alignment with US and International regulations and standards, as well as Abbott quality systems.
•  Responsible for AV Quality Commercial Excellence PMO, globally. The incumbent is responsible for oversight of quality practices for the commercial organization.  This includes the development, implementation and maintenance of systems around commercial distribution of Vascular products, and quality responsibilities for distributors/in-country partners and affiliates around the world who distribute product and/or take customer complaints. The incumbent will take a proactive approach ensuring that all regulatory requirements and company QA policies and procedures are met as part of any commercial launches and/or applicable pilot program discussions.
• The role also has responsibility for active participation on the CAPA Review Board for internal Exception Reports, Corrective Actions and Investigations.  The incumbent will also play a key role in external inspections/audits that take place in the across commercial affiliates or Corporate Audit.  This position also provides support for development and implementation of any required corrective action plans resulting from affiliate audits.
• Some functional site responsibilities may require providing high level direction of all activities related to calibration of measurement equipment used throughout the organization in accordance to policy, including equipment traceability, out of tolerance management, and interval management.
• Assures Quality provides technical support and services to Operations and Research & Development functions. Supporting approved projects and objectives of both functions.
• Identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
• Be a champion of Quality, Lean and disciplined problem solving throughout the organization to identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
• Provide influential leadership with US and OUS sites to drive proactive quality improvements and harmonization.
• Provide diligent and fact-based communication to Executive Management team, peers, and team.
• Provide management and development of the Quality staff.
• Be an effective member of the cross-functional Director organization to foster continuous quality compliance, cost, and predictive measures improvements by maintaining effective Quality Metrics and define and execute activities to resolve decreases in performance.
• Support all Divisional initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, including EN ISO 13485, 21CFR 820 Quality System Regulation, MDD, JPAL and CMDR.
• Ensures that product acceptance activities are handles in a manner that complies with all pertinent regulatory requirements. Reports on the performance of the quality system

Required Qualifications

• Bachelor’s degree + 16 years experience
• Minimum 10 years In quality desired with at least 3+ years management of demonstrated compliance excellence, value improvement, risk reduction, and cost containment
• Demonstrated ab