QA Compliance Manager

Location: 

Basel Area, Allschwil, 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 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.

 

Job Responsibilities


•    Verify by independent audit GMP compliance at third party service providers and within internal facilities
•    Establish and maintain the external QA audit plan and internal self-inspection program
•    Manage the External Supplier Qualification process and maintain the list of approved suppliers
•    Conduct GMP/GDP audits and self-inspections and coordinate with internal personnel and suppliers to schedule, execute and follow up on audit observations
•    Promptly report critical findings to the Responsible Person and Management 
•    Manage, review and approve change controls, deviations and CAPAs related to the internal pharmaceutical operations facilities (not project specific)
•    Write, review, and/or approve internal quality system SOPs and other GMP/GDP and regulatory related documentation 
•    Evaluate, develop, establish, and maintain internal processes and procedures for compliance with GMP/GDP standards and for process improvement (QS document including Quality agreements with third parties) 
•    Management of quality documents including use of EDMS systems used for electronic records 
•    Support and participate in Regulatory Authority Inspections 
•    Monitor changes in quality regulations and initiate required activities to maintain compliance of the quality system 
•    Collect and analyze all the information needed to prepare the Quality Management Review
•    Support optimization of Idorsia's pharmaceutical quality system by participating in the review of relevant Key Performance Indicators (with a focus on supplier’s performances)

 

Candidate’s Requirements 


•    University degree in Pharmacy, Chemistry or alternative technical/science university degree
•    Minimum 3 years’ experience as Auditor in GMP field, at least 1 year as Lead Auditor
•    Knowledge and experience in at least one of the following activities: drug product development, manufacturing processes, as well as quality control, packaging and distribution aspects 
•    Excellent knowledge of relevant GMP/GDP and international quality regulations e.g. ICH, ISO, WHO, PIC, FDA, EU GMP Guide (EudraLex Vol. 4), EU GDP and ability to interpret and implement quality standards 
•    Ability to work with multiple stakeholders within various disciplines and to manage complex projects and prioritize workloads according to the project importance 
•    Attention to detail, well-organized, ability to multi-task with good interaction with personnel at all levels
•    Ability to pro-actively initiate and lead quality compliance activities 
•    Self-confident, assertive and ability to deal with complex stakeholders/situations
•    Strong interpersonal and influencing skills 
•    Fluent verbal and written communication skills in English and at least basic knowledge of an additional European language e.g. German or French 
•    Experience in Medical Devices is a plus

 

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
  • A competitive salary and generous social benefits

 

Work  Location: Allschwil

Country: Switzerland

Business Area: Pharmaceutical Development

Schedule: Fulltime

Job Type: Permanent

Job ID: 1327

 

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 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.