QA Manager (GMP/GDP)

Location: 

Allschwil-Basel Area, CH

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 1000 highly qualified specialists dedicated to realizing our ambitious targets.

 

We are looking for a QA Manager GMP GDP to join our dynamic and motivated team !

 

Job Responsibilities 

 

  • Provide GMP/GDP quality assurance expertise during development and commercialization of Idorsia’s products
  • Ensure all required quality activities are initiated and completed according to the development or commercial stage
  • Ensure that medicinal products are designed, developed, manufactured and controlled according to adequate quality standards
  • Support review and optimization of the company's pharmaceutical quality system for assigned processes. 
  • Pro-actively participate to the optimization of the quality system by proposing new procedures, tools or modification of existing ones
  • For assigned projects, provide guidance on the resolution of complaints, testing issues, deviations, discrepancies and Out of Specifications (OOS), investigations and propose Corrective and Preventive Actions (CAPA) as needed
  • Establish a quality risk management approach in projects based on six sigma concepts and training 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, commercial products and/or investigational medicinal products including approval of master process documentation, batch record review and assessment of change controls
  • Notify CMC team and management of potential quality, regulatory and lead time issues
  • Participate, represent and defend quality activities in CMC team meetings
  • Assist in the conduct of GMP/GDP audits at 3rd party sites when needed 
  • Preparation of GMP/GDP Agreements in collaboration with CMOs and the CMC team
  • Write, review, and/or approve internal SOP’s and other GMP/GDP related documentation

 

Candidate's requirements

 

  • University degree in Pharmacy, Chemistry or alternative technical/science university degree: master level minimum preferred.
  • >3 years of experience in different positions like pharmaceutical product development/ quality control/ analytical development/ chemical production or similar operational positions in the pharmaceutical industry
  • >3 years of experience in quality assurance of drug substance and/or drug product
  • Knowledge and understanding of Drug Substance and/or Drug Product development, manufacturing process, quality control, packaging and distribution.
  • Qualification to become an EU Qualified Person (and/or FvP) an added value. 
  • Good knowledge of (c)GMP/GDP’s 
  • Ability to interpret and implement Quality standards 
  • Ability to manage complex projects and prioritize workload according to the project importance
  • Ability to pro-actively initiate and lead quality activities  
  • Ability to manage multiple tasks with competing priorities 
  • Good interpersonal and influencing skills 
  • Self-confident, assertiveness and autonomy to deal with complex stakeholders/situations
  • Ability to communicate clearly and professionally both verbally and in writing
  • Fluent in English and at least basic knowledge of an additional European language, German or French advantageous

 

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 benefits


Work Location: Allschwil - Basel Area
Country: Switzerland
Business Area: Global Pharmaceutical Development - Quality Assurance
Schedule: Full time
Job Type: Permanent
Job ID: 3483

 

If you are interested, please click on apply now.

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.