Director of Quality Operations
GE Healthcare Bio-Sciences AB / Kemiingenjörsjobb / Ospecificerad arbetsort
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hela Sverige Visa alla jobb hos GE Healthcare Bio-Sciences AB i Ospecificerad arbetsort Role Summary/Purpose:
The QO Director will have the overall responsibility for Oslo Site Quality Operations, i. e. QA and QC units for Oslo Plant incl. Process Chemistry (PC) and Pharmaceutical Pilot Plant (PPP), as well as QA responsibility for Technology Development (TD) and New Product Development (NPD).
The Oslo site has 400 employees in total and is located at Storo.
Essential Responsibilities:
The QO Director is part of the plant and site management group and reports into the central Quality unit. The overall objective of the function is to ensure that the GE Healthcare AS functions at Oslo site manufacture and release products in accordance to conditions laid down in the Manufacturing License, actual Marketing Authorization or New Drug Applications, guidelines for Good Manufacturing Practice and CFR 21 parts 210 and 211, and company Quality Standards.
Responsibilities in details:
Head of the QO unit with responsibility for approx. 70 employees within QA and QC. This includes to proactively reevaluate the strategy, set common long term goals and to inspire the team to work passionately on those.
Continuously challenges and rewards team members for taking action.
Reexamines critical assumptions, seek differing perspectives and suggest new ways of solving problems.
Aligns and coordinates with key stakeholders locally and internationally.
Identifies core competencies for the future and systematically develop the team?s capabilities.
Accountable for ensuring full quality and regulatory compliance of the plant (incl GMP), while driving process effectiveness and efficiency at the site.
Ensures site audit readiness and responsible for the Quality System audits; prepares and executes Quality Management System reviews.
Has authority to stop productions, issue product holds, make decisions about budgets and people accountability, release products and sign of project milestones.
Maintains positive agency relationships-liaisons with regulatory agencies upon site inspections and participates in external technical forums.
Qualifications/Requirements:
Master's Degree in Pharmacy, Chemistry, Biology, or other relevant discipline.
Minimum of 5 years' management experience.
Extensive cross-functional and managerial experience from a pharmaceutical industry preferably in Manufacturing, Quality Control/Quality Assurance.
Ability to determine long-term objectives and priorities and puts vision behind every action.
Ability to identify promising strategies and to evaluate the need for a major change in strategy.
Ability to inspire and develop employees, teams and an organization.
Likes to spend most of the time as a coach vs a reviewer of work, and ability maximize others contributions.
High degree of fluency in spoken and written English, and able to read and speak Norwegian.
Varaktighet, arbetstid
Tillsvidare
Heltid
Publiceringsdatum2015-05-01ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2015-05-31
Please apply online at
Klicka på denna länk för att göra din ansökanAnge följande referens när du ansöker: 2008648
FöretagGE Healthcare Bio-Sciences AB
KontorsadressNycoveien 1-2,
Oslo
Övriga kontaktuppgifterTelefonnummer: +47 40914519
Jobbnummer 2274881
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