Senior GMP/GDP QA Manager Drug Products - Combination Products

About Idorsia Pharmaceuticals Ltd

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 companies, with a strong scientific core.

Headquartered in the Basel Area (Allschwil) 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 800 highly qualified specialists dedicated to realizing our ambitious targets.

We are looking for an enthusiastic and motivated Senior GMP/GDP QA Manager Drug Products - Combination Products to join our team !

Job Responsibilities

• Provide GMP/GDP expertise thus ensuring that medicinal products are developed, manufactured, packed, labelled, distributed and controlled in accordance with regulatory expectations and applicable quality standards
• Perform GMP onsite audits at Contract Manufacturing Organizations (CMOs)
• Preparation of Quality Agreements in collaboration with CMOs and the CMC team
• Prepare, review, and/or approve internal SOPs and other GMP/GDP related documentation
• Execute QA 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
• Establish a quality risk management approach in projects based on ICH Q9 concepts to ensure that quality is understood and managed by all stakeholders throughout the product life cycle
• For assigned projects, ensure resolution of deviations, complaints, testing issues, discrepancies, Out of Specifications (OOS) and Corrective and Preventive Actions (CAPA)
• Notify management of potential quality and regulatory issues
• Support the review and optimization of the company’s pharmaceutical quality system by establishing relevant Key Performance Indicators.

Candidate’s Requirements

• Advanced University degree in Pharmacy (preferred), 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 product covering also combination products
• Excellent knowledge of GMP and GDP requirements, ability to interpret and implement quality standards
• Knowledge of drug product manufacturing, control, packaging and distribution procedures
• 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 environment where you can make a difference
• An innovative and open culture in a truly multicultural environment
• A competitive salary and generous social benefits

Work Location: Allschwil- Basel Area

Country: Switzerland

Business Area: Quality Assurance

Schedule:Fulltime

Job Type: Permanent

Job Code: 2628

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 will be informed in greater detail in due course.

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, please note that 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.