Director, Global Quality Assurance & Environmental Management
Thermo Fisher Scientific / Organisationsutvecklarjobb / Uppsala
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hela Sverige Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Our four premier brands - Life Technologies, Thermo Scientific, Fisher Scientific and Unity Lab Services - offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit
www.thermoscientific.com/phadiaDirector, Global Quality Assurance & Environmental Management
Reports To: Vice President, QA, RA & EM
Group/Division: SDG/IDD
Position Location: Uppsala, Sweden
Number of Direct Reports: 8
We are looking to recruit a senior Leader for the role as Director, Global Quality Assurance & Environmental Management. You will be responsible for continuing to develop our Quality and Environmental Management Systems to constantly meet industry standards, and to ensure compliance with all regulations relevant for the in-vitro diagnostic industry. Acting as a change agent is your attribute, and your desire to develop strong teams toward a World Class quality organization is another key asset in this important leadership position. The position requires senior management experience operating in an international environment.
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Our four premier brands - Life Technologies, Thermo Scientific, Fisher Scientific and Unity Lab Services - offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit
www.thermoscientific.com/phadiaPosition Summary:
As Director for Global Quality Assurance (QA) and Environmental Management (EM), you are responsible for ensuring divisional compliance of regulatory directives and standards applicable to the medical device and in vitro diagnostic industries as relevant for all markets being served. This position oversees and directs global quality and environmental systems/compliance activities, provides quality management guidance to the entire organisation, as well as manages the global QA & EM teams. This position is also responsible for making decisions that affect the product safety and efficacy and the company's reputation in the market. The position reports to the Vice President of Global QA, RA & EM, and serves as a key business partner, working closely with the entire organization to ensure division wide compliance and product quality.
Key Responsibilities:
• Ensure global compliance with medical device and in vitro diagnostic regulations, directives and standards
• Develop the functional strategic roadmap to match and support the overall business goals
• Assess current organizational structure in quality. Make and implement recommendations and changes that will move the business toward a World Class quality organization.
• Be the ambassador for continuous improvements of product quality and services.
• Improve the customer experience regarding initial quality and long- term reliability by leading quality related cross-functional collaboration throughout the life cycle management process. This will involve strong cross functional skills to arrive at the most effective execution of the Quality System.
• Assure proper communication and company-wide training related to regulations applicable to the medical device and in-vitro diagnostic industries.
• Interface, as necessary, with regulatory agencies and professional organizations in order to verify that corporate and departmental systems remain current and competitive.
• Manage, audit, analyze and propose improvements in the Quality Management System.
• Establish, organize & monitor the annual Quality Plan improvement efforts
• Lead and manage external inspections, e.g. from the FDA or a Notified Bodies, customer audits and other third party Quality System evaluations.
• Author, change and update Quality Manual and QA procedures as applicable.
• Maintain up-to-date knowledge of all applicable regulations, guidelines and standards.
• Conduct Quality Management Reviews, ensuring periodic cross-functional evaluation of quality metrics and implement corrective actions against adverse trends and non-conformances.
Requirements/Qualifications:
• University degree in medical/technical sciences
• Significant experience from quality and environmental management systems in an IVD/Medical device environment, e.g. QSR, EU medical directive, ISO 13485, ISO14001, ISO14971, etc.
• Minimum of 10 years in a medical regulated industry with 5 or more years in a management position, including personnel and budget responsibilities.
• Senior experience in managing external inspections from competent authorities and notified bodies.
• Experience in building long term strategies and execution.
• Experience in global operations and vigilance management reporting.
• Excellent verbal/written communication skills; fluency in Swedish and English preferred.
• Willingness to travel in order to accomplish assigned goals. ( (Up to 15 % of your time)
Interpersonal and Leadership skills:
• Coaching Leadership style with ability to set clear direction and delegate authority.
• Being a role model leader in developing and motivating people at all levels.
• Proven ability to adapt to changing organizational and operational needs and the ability to lead others through change.
• Strong team player and leader with the ability to work across multiple functions and disciplines.
• Creating an energetic and forward looking environment.
• Ability to create a strong quality culture, fostering integrity.
• Build trustful and strong networking relationships.
• Creative, with analytical problem solving skills.
For further information please contact:
Annika Berg, Vice President, Global QA, RA & EM + 46 18 166551
Håkan Olsson, Director HR + 46 18 165346.
Publiceringsdatum2015-02-02Arbetstider och omfattningTillsvidare
Heltid
ErsättningFast månads- vecko- eller timlön
Så ansöker duPlease send your application with CV and marked reference no.6 to
hr.idd@thermofisher.com no later than 18th of February 2015.
Ansökan kan skickas till e-postadress:
hr.idd@thermofisher.comKontaktAnnika Berg, Vice President, Global QA, RA & EM, + 46 18 166551
Håkan Olsson, Director HR, + 46 18 165346.
FöretagThermo Fisher Scientific
AdressThermo Fisher Scientific
Box 6460
75137 UPPSALA
KontorsadressRapsgatan 7P
Övriga kontaktuppgifterTelefonnummer: 018-165000
E-postadress:
hr.idd@thermofisher.com Jobbnummer 2151685
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