Qualification Services Manager - Enterprise
GE Healthcare Bio-Sciences AB / Kemistjobb / Uppsala
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GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
Role Summary:
The specific function as KUBio Qualification Services Manager within Enterprise Solutions has the responsibility for qualification and commissioning strategy so as planning and execution of the same for KUBio's.
Key Responsibilities / Essential Functions:
Strategy part
• Develop strategy for Qualification and Commissioning for the KUBio projects based on regulatory requirements. Standardize and develop a document plan and document templates fulfilling regulation requirements which secure a seamless delivery and quality of needed documents.
• Owner of and responsible for template documents for KUBio Qualification and Commissioning.
• Support Qualification Services on regulatory requirements on FlexFactory Qualification and Commissioning.
Contract phase
• Responsible for generation of QMP, QM and CMP (Qualification master plan, Quality matrix and Commissioning master plan) documents prior to contract signature.
• Leading discussions and coordination between customer and E&O team during contractual phase for QMP, QM and CMP.
• Responsible for coordinating with KUBio vendors regarding requirements/ expectations from GEHC on document deliverables.
Execution phase
• Act as a PM for KUBio Qualification an Commissioning during execution with 20-30% on site appearance.
• After contractual signature lead and coordinate all qualification and Commissioning documents in close coordination with ESPM, generate a proper document plan which includes clear defined responsibilities and secure that it is communicated to customer and 3rd party vendors.
• Review and secure that all prepared documents are reviewed by necessary functions and are fulfilling GE requirements as defined in the strategy.
• Drive and have the responsibilities for all activities regarding review, t-cons, meetings etc on Qualification topics with customer and vendors in close cooperation with ESPM (Enterprise Solutions PM).
• Follow up with involved parties to secure the document project plan is kept.
• Responsible for manpower load of subject matters experts (on site/off site) to secure deliverables from KUBio vendors in close cooperation with ESPM.
• Close coordination between Customer/Vendor/ESPM in all aspects of Qualification/ Commissioning matters.
• Responsible for securing lessons learned are in cooperated in templates and WoW.
Support Function
• Support other Enterprise groups so as FF Qualification Services on regulatory matters.
• Participation in audits performed by our customers as appropriate.
Qualifications/Requirements:
The specific function as KUBio Qualification Services Manager within Enterprise Solutions has the responsibility for qualification and commissioning strategy so as planning and execution of the same for KUBio's.
The goal is to secure that all regulatory requirements are fulfilled and protocols are developed according to defined document templates both by GE and 3rd party vendors in timely manner according to defined project plan.
The KUBio Qualification Services Manager position requires close cooperation with:
• KUBio suppliers
• Customers
• Enterprise Project Manager (ESPM)
• Evaluation and Offering Team (E&O)
• Regulatory affairsFF Qualification Services
The candidate must be able to manage the interactions in a matrix/cross-functional organization structure to ensure timely execution of Qualification and validation activities.
The KUBio Qualification Services Manager will report into the Enterprise Service Leader who is globally responsible for the implementation of FlexFactory and dotted line into Evaluation and Offering (E&O) Team Leader.
Qualifications/requirements:
• Bachelor's or Master degree in technology, biotechnology, cell biology, biochemistry or equivalent experience (defined as High School -Diploma/GED and major experience in above mentioned fields).
• Expert within methods of equipment validation in GxP environment.
• Expert in relevant industrial standards such as GAMP5, ASTM E2500, ISPE, ICH.
• Profound project management skills.
• An understanding of marketing, sales and support processes, customer needs and have product knowledge.
• Solid knowledge of GE Upstream and Downstream equipment.
• Ability to work effectively across functions to deliver results and execute multiple commitments within the Global Environment.
• Multitasking abilities to drive critical issues simultaneously.
• Resourcefulness, commitment, interpersonal, communication and negotiation skills.
• Excellent verbal and written communication skills in English.
• Excellent skills in MS Office products.
• Be based in Uppsala (SE) as preferred priority or Marlborough MA (US) and ability to travel 20%- 40%.
Desired Characteristics:
• Strong organization, planning and presentation skills
• Service and team oriented
• Strong business sense with an ability to work independently
• Innovative, resourceful and flexible
• A good sense of quality and high energy with the ability to meet all assigned deadlines
• Be able to prioritize and run project with needed rigor to be able to meet delivery dates
If you have questions regarding the position please contact Adam Jarolics +45 2460 5550. Last day to apply is August 15th.
Locations:
Sweden; Uppsala
Publiceringsdatum2018-07-31Så ansöker duSista dag att ansöka är 2018-08-26
Klicka på denna länk för att göra din ansökanFöretagGE Healthcare Bio-Sciences AB
KontorsadressBjörkgatan 30
Jobbnummer 4267563
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