Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.
In order to achieve this, we will develop Idorsia into one of Europe’s leading biopharmaceutical company, with a strong scientific core.
Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet – the ideal constellation to bringing R&D efforts to business success.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 600 highly qualified specialists dedicated to realizing our ambitious targets.
Quality Manager Drug Substance Job ID: PD1733
Provide GMP/GDP quality assurance expertise during development and later during commercialization of Idorsia’s products
Perform GMP onsite audits at Contract Manufacturing Organizations (CMOs)
Preparation of GMP/GDP Agreements in collaboration with CMOs and the CMC team
Write, review, and/or approve internal SOP and other GMP/GDP related documentation
Ensure that medicinal products are designed, developed, manufactured and controlled according to quality standards
Establish a quality risk management approach in projects based on six sigma concepts to ensure that quality is understood and managed by all stakeholders throughout the product life cycle
Manage all required activities to support release of active ingredients, investigational medicinal products including approval of master process documentation, batch record review, resolution of investigations, and assessment of change controls
Notify management of potential quality and regulatory issues
For assigned projects, provide guidance on the resolution of complaints, testing issues, discrepancies and Out of Specifications, investigations and Corrective and Preventive Actions as needed
Support review and optimization of the company’s pharmaceutical quality system by establishing and preparing review of relevant Key Performance Indicators.
Advanced University degree in Pharmacy, Chemistry or alternative technical/science university degree
Minimum of 5 years’ experience in different positions like pharmaceutical or chemical development, quality control, analytical development, chemical or pharmaceutical production or similar operational positions in the pharmaceutical industry
In addition, minimum of 3 years’ experience in quality assurance of drug substance
Excellent knowledge of GMPs and regulatory environments, ability to interpret and implement quality standards
Strong interpersonal and influencing skills
Excellent verbal and written communication skills in English
Ability to manage multiple tasks with competing priorities
Entrepreneurial mind set combined with cost consciousness
What Idorsia offers
Exciting opportunities for development and professional growth within our dynamic organization
A collaborative and solution oriented enviroment where you can make a difference
An innovative and open culture in a truly multicultural environment
If you are interested, please send your CV and motivation letter by email to email@example.com clearly stating the job title and reference of the position to which you are applying in the subject line.
Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course.
Please note Idorsia operates a strictly-controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.