QA Director, Commercial and Affiliate

Overview

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.

• Define and communicate overall vision and cascaded objectives for the departments.
• Provide overall leadership for Quality policies, approaches, and standard practices. Maintain alignment with US and International regulations and standards, as well as Abbott quality systems.
• Oversee AV Quality Commercial Excellence PMO globally. Responsible for quality practices for the commercial organization, including development, implementation and maintenance of systems around commercial distribution of Vascular products, and quality responsibilities for distributors/in-country partners and affiliates worldwide who distribute product and/or handle customer complaints. Proactively ensure regulatory requirements and company QA policies and procedures are met for any commercial launches and/or applicable pilot programs.
• Participate on the CAPA Review Board for internal Exception Reports, Corrective Actions and Investigations. Play a key role in external inspections/audits at commercial affiliates or Corporate Audit, and support development and implementation of corrective action plans resulting from affiliate audits.
• Provide high level direction for calibration of measurement equipment used throughout the organization in accordance with policy, including equipment traceability, out of tolerance management, and interval management.
• Provide technical support and services to Operations and Research & Development functions, supporting approved projects and objectives of both functions.
• Identify opportunities to proactively ensure compliance with applicable internal, domestic and international quality regulations (US 21 CFR 820, ISO 13485, and related requirements).
• Champion Quality, Lean and disciplined problem solving to add value through risk reduction, cost improvement, and budgetary responsibility.
• Provide leadership with US and OUS sites to drive proactive quality improvements and harmonization.
• Communicate diligently and fact-based with Executive Management, peers, and team.
• Manage and develop the Quality staff.
• Collaborate within the cross-functional Director organization to foster continuous quality compliance, cost and predictive measures improvements by maintaining effective Quality Metrics and executing actions to address performance declines.
• Support Divisional initiatives in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Comply with FDA regulations and other regulatory requirements, company policies, procedures, and tasks. Maintain positive and cooperative communications with all levels of employees, customers, contractors, and vendors.
• Aggressively identify opportunities to proactively assure compliance with internal, domestic and international quality regulations (including EN ISO 13485, 21 CFR 820, MDD, JPAL and CMDR).
• Ensure product acceptance activities are conducted in compliance with regulatory requirements and report on the performance of the quality system.

• Bachelor’s degree plus 16 years of experience
• Minimum 10 years in quality with at least 3+ years in management of demonstrated compliance excellence, value improvement, risk reduction, and cost containment
• Demonstrated understanding of applicable FDA and TÜV regulations, and other clinical/regulatory requirements. Class III or II medical device background in a Quality Leadership role. Knowledge of Quality System Regulations (ISO 9001, ISO 13485).
• Strong leadership skills with ability to create momentum and deliver results. Strong organization, communication, and influential management ability. Ability to work in a highly matrixed and geographically diverse environment. Ability to set goals and provide constructive feedback to build positive relationships and improve results.
• Ability to work effectively in a team in a fast-paced, changing environment. Strong verbal and written communication with ability to communicate at multiple levels. Multitasking, prioritizing and meeting deadlines; strong organizational, planning, and follow-up skills and accountability.

• Master’s Degree Preferred

APPLY NOW:
The application process is ongoing. Please review all qualifications and requirements and submit your materials as directed by the posting.

Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:
Abbott benefits site ().

Follow your career…