Head of Quality Operations to Novavax
Badenoch & Clark / Övriga jobb / Uppsala
2017-09-18
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hela Sverige Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant protein nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Novavax is involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea and PATH. Together, Novavax ' network supports its global commercialization strategy to create real and lasting change in the biopharmaceutical and vaccinology fields. Additional information about Novavax is available on the company 's website,
www.novavax.com.We are seeking a Head of Quality Operations to join our Quality Operations Department at our subsidiary Novavax AB with placement in Uppsala, Sweden. Novavax AB develops, manufactures and supplies the Group 's proprietary adjuvant - Matrix - both to Novavax 's own vaccine development program as well as to external customers in the U.S. as in the EU.
The Head of Quality Operations in Uppsala will play an important role in ensuring that Novavax ' manufacturing and product release are in accordance with the requirements of its marketing authorization or approval for commercial use and clinical trial, GMP and other legal requirements. This individual will also lead the Novavax AB 's Quality Assurance Department as well as the Quality Control Department in Uppsala, including management of staff - about 10 people or more.
Responsibilities include but are not limited to:
Job description
• Responsible for successful leadership and management of the Quality Unit according to the strategic direction set by the Board of Directors and Executive Leadership.
• Develop site 's Quality vision and strategic plan including development of an organizational plan that incorporates goals and objectives of the group, including the regular interface with US Heads of Quality Assurance, Quality Control, and Global Manufacturing Operations.
• Ensure the effective and efficient day to day operation of the Quality function.
• Oversee the planning, implementation, evaluation, and continuous improvement of the Quality Management System to support product development and manufacture of adjuvants to supply EU, US, and ROW clinical trials and customers,
• Oversee the planning, implementation, evaluation, and continuous improvement of the Quality Control test operations including data trending, reagents and standards development, assay transfer, assay validation, and technical investigations.
• Manage a combined QA/QC headcount of 10+ team members.
• Interface with multiple Qualified Persons (QPs) at site and corporate level as necessary to ensure portfolio product release goals are aligned and achieved.
• Prepare budgets and ensure spend is according to the approved budget.
• Identify, evaluate, and mitigate risks to organizational success.
• Establish good working relationship and collaborative arrangements with internal and external stakeholders and partners.
• Oversee and/or participate in selection and implementation of multiple electronic system solutions to increase business efficiency and compliance.
Minimum Requirements:
• 10+ years ' technical experience in QA/QC from Biopharmaceutical and/or Vaccine industry
• 5+ years in a leadership role.
• Good knowledge and understanding of (at minimum) the Swedish MPA, US FDA, and EU MHRA regulations, including a proven track record of managing regulatory inspections.
• Proven technical and quality track record in advancing products from late stage development through and including commercial application, including PPQ activities. Experience with computerized quality system platforms (implementing as well as using)
• Experience with assay method development and/or lab operations
• Previous experience from working as a QP in Sweden is meriting
• Excellent language knowledge and communication skills (oral and writing), Swedish and English
• Ability to work in a global environment, with reporting structure in the US
• High integrity
• Business drive, understanding of Novavax 's needs and priorities
We are seeking an individual with excellent leadership capabilities. We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply.
How to apply
In this recruitment we cooperate with Badenoch & Clark. You register your application below or at badenochandclark.se, including your personal letter and CV in English. Please contact recruitment consultant Anette Eriksson if you have any questions, 018-65 33 06 . We look forward for you application no later than Sep 24th.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2017-09-18ErsättningFast lön
Så ansöker duSista dag att ansöka är 2017-09-24
Klicka på denna länk för att göra din ansökanKontaktAnette Eriksson 018-65 33 06
FöretagBadenoch & Clark
AdressBadenoch & Clark
Dragarbrunnsgatan 42
75320 UPPSALA
KontorsadressDragarbrunnsgatan 42
Jobbnummer 3704591
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