Working with the North America Commercial affiliates to provide support and guidance regarding · Providing Quality Systems leadership, tactical and strategic direction as well as technical support to approx. 30 commercial affiliates. · Assure that quality related issues associated with products distributed by the affiliates conform to current Good Manufacturing Practices (cGMP) /Good Distribution Practices (cGDP), Abbott Quality standards, and other applicable regulatory standards - The position will report directly to the QA Operations Director, and will have direct reports for the region- Regional CAPA and Complaints. In addition the position will have Global QA Distribution oversight.
Promote sound, quality principles at Commercial Affiliates while minimizing cost increases and potential disruptions to business.
Understand and support Abbott Nutrition Commercial quality organization and issues.
Develop and manage the North America Commercial Affiliate Quality Plan.
Provide training to ensure compliance with identified quality goals and standards.
Provide overall technical and documentation support of commercial affiliates.
Support local market outsourcing activities and product launches through management of the First Lot Quality Review program.
Support cost effective systems necessary to assure that products that are locally manufactured and or distributed comply with Abbott Nutrition QA policies and local regulatory/cGMP requirements.
Manage projects and programs as assigned by Abbott Nutrition management.
Represent the Commercial Affiliates on Cross-Region/Divisional and/or Corporate teams.
Serve as the region liaison with guest division (ANI) on Quality System matters.
Act as Region technical resource regarding Quality Systems and compliance.
Implement and manage quality systems and training programs as necessary to support CAPA, validation, complaint registration, physician sample handling, inspectionreporting and tracking, policy implementation, etc. at the commercial sites.
Liase with guest division (ANI) regarding quality issues and services managed thought the host Abbott Nutrition commercial sites.
Host services provided may include but are not limited to product inspection, overlabeling and product release services provided for products for division markets.
Manage technical or service level agreements as necessary between quality system providers or guest organizations.
Drive the Management Review process for Commercial Affiliates at the regional level.
Advise Senior Management of compliance status and risk.
Position will oversee decision-making process in determining field actions and associated activities in local markets.
Position will coordinate activities between commercial sites, plants and distribution centers as necessary to ensure policy requirements are met in respect to field actions.
Interpret and evaluate local markets regulatory requirements and standards.
Position will represent local markets in Corporate or Regional/Division led quality initiatives to determine applicability and scope of implementation.
Position will compare and evaluate benefits, local standards and expectations and compliance risks vs. cost.
Integrate key AQR/Abbott Nutrition initiatives (Soltraqs, SOLID) into commercial sites as appropriate, based on compliance risk and availability of resources and business processed to support.
Position reports to and is accountable to the Direct, Global Commercial & Distribution Quality Assurance.
The commercial QA Manager (North America) is responsible for ensuring that Abbott Nutrition commercial affiliates implement and maintain cost effective quality system solutions and remain in compliance with regulatory requirements.
Failure to meet this goal can result in Abbott Nutrition not fulfilling the commitments of the region/division or corporate compliance plans.
Financial penalties to the division, regulatory action and/or wasted resources are possible consequences.
As importantly, the quality of Abbott Nutrition products is a competitive advantage in the market place, and any lessening of our standards can have an adverse long term impact on our business.
College or University degreerequired, technical (life Sciences) or business related discipline · QP eligibility is preferred · Pharmaceutical or medical device (or related industry) QA/Regulatory Operations 5+ years · Management of complex project or programs 2-3 years