Team Lead Quality Assurance Drug Product / EU Qualified Person

Location: 

Basel Area - Allschwil, BL, 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

 

  • As Expert Quality Manager, lead and supervise a group of Quality Managers focusing on Drug Product development and later, commercialization of Idorsia's products
  • Manage the group/direct reports by setting goals, organizing resources, coaching and providing feedback to direct reports
  • 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
  • Oversee all required QA activities to support release of drug products and finished packed commercial products including, approval of master process documentation, batch record review, resolution of investigations and assessment of change controls
  • Ensure resolution of complaints, testing issues, discrepancies, Out of Specifications (OOS) and Corrective and Preventive Actions (CAPA)
  • Prepare, review, and/or approve internal SOPs and other GMP/GDP related documentation
  • Prepare GMP/GDP Quality Agreements
  • As the appointed EU QP, take responsibility for the release of IMPs and later, commercial products to the market
  • 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.
  • Participate in GMP/GDP regulatory authority inspections and support affiliate sites in the implementation of compliant quality systems

 

Candidate’s Requirements

 

  • Advanced University degree in Pharmacy (preferred), Chemistry or alternative technical/science university degree
  • At least 5-years' experience in Quality Assurance role and specifically, as appointed EU Qualified Person in accordance with "Arzneimittelgesetz, §15"
  • At least 10 years’ experience in different positions like pharmaceutical product development, quality control, analytical development, chemical production or similar operational positions in the pharmaceutical industry, which includes experience in a leadership/line management role
  • Excellent knowledge of GMP and GDP requirements, ability to interpret and implement quality standards
  • Sound knowledge of drug product and combination product manufacturing, control, packaging and distribution procedures
  • Strong interpersonal and influencing skills to facilitate team work and strong cross functional working relationships
  • Excellent verbal and written communication skills in English and German
  • 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
  • A competitive salary and generous social benefits

 

 

Work  Location: Allschwil

Country: Switzerland

Business Area: Pharmaceutical  Development

Schedule: Fulltime

Job Type: Permanent

Job ID: 1117

 

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.

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