The European Quality AssuranceManager is directly responsible for implementing and maintaining QualityManagement Systems in compliance with Abbott and ISO requirements and countryspecific regulations.
This position requires a highly experienced profile, ensuring compliance ofmulti-European site Quality Management Systems through both day to day businessoperations and the organisations’ Quality Objectives.
The position reportsto Senior Manager Commercial Quality Assurance.
Within the InfectiousDisease Developed Market (IDDM) commercial organization, the EU QA IDDMCommercial Manager is working in conjunction with the personnel at eachlocation to establish value added procedures.
The specific responsibilities include administration of quality systemprocesses for internal / external audits, CAPA, deviation management, training,document control, record control, risk management and quality managementreviews.
Abbott is lookingof a dedicated QA Commercial Manager to lead and administrate the QualityManagement Systems for our Italian andPortuguese commercial entities.
This role will also support and provideassistance, as needed, to the Nordics Commercial Quality team located in Oslo,Norway.
The position islocated preferably in Milan, Italy. With regular travel to Lisbon Portugal and occasionaltravel to Nordic countries.
Main responsibilities IDDM Italy and Portugal
The EU QA IDDM Commercial Manager is directly responsible forimplementing and maintaining each local QMS in compliance with Abbott and ISOrequirements and country specific regulations.
This shall be managed inconjunction with the personnel at each location.
The main responsibilities are the following :
Contribute to the development of company objectives and maintain acompliant Quality Management System.
Operates with business latitude and quality focus. Determines and develops approach to solutionswhere situations may have little or no precedent, with new and expanding businessoperations.
Makes prompt and sound decisions under conditions of uncertainty, thatproduce effective end results. Appliesrisk assessment techniques in such circumstances.
Drives improvements through management of projects, mentoring andsupport of local personal.
Drives compliance cross-functionally in alignment with the business unitobjective for collaboration, any local compliance specificities in Italy andPortugal and each site ISO9001 certification.
Maintains quality agreements with Third Parties, both intercompany andexternal.
The position also includes the following duties :
Implement new or modify existing processes to maintaincompliance with local entity, business unit, division, corporate, voluntarystandards and regulatory requirements.
Administrate quality system processesincluding document control, record control, training, internal audits,deviation management and CAPA.
Responsible for coordination and management of site Qualitymetric tracking, trending and reporting activities. Assure metrics appropriately characterize thekey performance indicators of the quality system.
Coordinate with entity management and facilitate QualityManagement Review activities, including quarterly quality objective reporting,escalation of issues with QMS impact and closure of open actions from previousmeetings.
The Quality representative for internalcompliance and 3rd party audits / inspections. Coordinate and manage all audits inconjunction with the Commercial office lead.
Manage Field Corrective Actionactivities
Facilitate Risk Management activities
Other duties as assigned.
The EU QA IDDM Commercial manageris also responsible for supporting IDDM Commercial Nordics’ QA team, whichincludes commercial and distribution activities in Norway, Denmark, Sweden andFinland.
This secondary role would include :
CoordinateBusiness Unit level tracking and trending activities including gathering informationneeded for Quality Management Review meetings
Assistwith quality system activities as identified by QA Nordics and IDDM CommercialQA management
Otherduties as assigned
Experience, Skills & Knowledge
BSc or equivalent in Lifesciences.
A minimum of 7 years’ experience with 5 years of progressivelyresponsible positions.
A broad knowledge of quality and regulated environments and industryregulators in Italy and Portugal.
Excellent communication skills (both verbal and written).
Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully in order to build positive relationships and improve business results.
Ability to work effectively within a team in a fast-paced changing environment. Multi-tasks, prioritizes and meets deadlines in timely manner.
A capacity to influence across European IDDM commercial sites to gainacceptance and accountability of multi-site collaborations
Possesses and applies a broad expertise of Quality Assurance, and itsapplication within an international company
Possesses advanced knowledge of QA commercial operations and practices to enable appropriatedecisions and provide recommendation to EU QA IDDM Commercial team and otherfunctional areas.
Language : Italian (fluent and / or native), Portuguese (Fluent and / ornative), English (professional C1 mimimum).