Senior Facility Compliance Manager

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

 

The Senior Facility Compliance Manager ensure the Clinical Manufacturing Units-operational readiness.

 

  • Implement effective qualification and preventive maintenance programs for the clinical manufacturing units and equipment's.
  • Ensure performance of existing equipment, used in solids and parenteral dosage forms, and utilities (HVAC, water, gas, etc.)
  • Collaborate in Engineering projects within the Clinical Manufacturing Units ensuring that GMP requirements are considered and fulfilled.
  • Coordinates facility compliance team and work with outside contractors.
  • Support equipment procurements, discussion with vendors, writing of URS, Qualification protocols and reports.
  • Support inspections by internal Quality Management auditors or external authorities
  • Coordination of cleaning verification / validation project teams and environmental monitoring activities
  • Manage Health and safety system.
  • Together with the Head of Clinical Manufacturing unis, develop and implement engineering solutions for in house projects requiring the development of liquids and semi-solids formulations, including parenteral.

 

Candidate’s Requirements

 

  • Engineer or Equivalent with Master's degree
  • Minimum of 5 years job relevant working experience in the pharmaceutical industry who has demonstrated previous success for leading teams and coordinate engineering projects.
  • Knowledge of GMP, oral and sterile production processes, based on current guidelines.
  • Previous experience in projects involving construction of new sterile facilities and/or implementation of aseptic fill and finish equipment and processes will be valued.
  • Ability to negotiate, plan, and coordinate in house activities to support operational readiness.
  • Excellent interpersonal skills with the ability to adapt effectively to rapidly changing organization issues, structures and dynamics
  • Excellent English knowledge (oral and written)

 

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: 1188

 

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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