Qualification Services Manager - Enterprise

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.

Essential Responsibilities: The Enterprise Solutions & Services deliver turnkey Vaccine/MaB factories called KuBio™ which is a modular built factory building including a FlexFactory™, which is based on single use principles, the FlexFactory typically consist of 80-90% GE equipment. Turnkey is understood as Installation, Calibration, Site Acceptance test and IQ-OQ of delivered equipment before handed over to customers.

More information can be found at https://www.gelifesciences.com/en/rs/solutions/bioprocessing/products-and-solutions/enterprise-solutions/Kubio

Enterprise Solutions within GE Healthcare Life Sciences are responsible for Preparing proposals for KUBio’s and FlexFactories(FF) Process design projects Project Management of KUBio and FlexFactory Supply Chain and logistic planning of FlexFactory equipment and automation Strategy, planning and execution of qualification and Commissioning of KUBio Commissioning and IQ-OQ execution of FlexFactory equipment including Automation

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 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 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. Resourcefulness, commitment, interpersonal, communication and negotiation skills. Excellent verbal and written communication skills in English. Ability to travel 20%- 40%. Uppsala, Sweden is the preferred location. Any other European city with proximity to a major airport may be taken into consideration too.

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.