Quality Manager

vor 23 Stunden

Zug, Schweiz iNova Pharmaceuticals Vollzeit

About INova

iNova is a different kind of health company. We are leading the way to better health by delivering innovative, patient-centric products that improve the lives of people around the world. Our diverse portfolio of iconic, market-leading consumer health brands and prescription medicines are backed by science and distributed in over 75 markets across Asia, Australia, New Zealand, Middle East & Africa and Europe. Experience the iNova difference today.


The Opportunity

We currently have an opportunity for a Quality Manager, to join our Quality Assurance team on a full-time basis.


Reporting to the Head of Quality Operations (EMEA and NA), core focus of the role is to be the Responsible Person (“fachtechnisch verantwortliche Person”) of iNova Pharmaceuticals (Switzerland) AG according to article 17 and 18 of Medicinal Products Licensing Ordinance (MPLO; SR 812.212.1). The successful incumbent will also be responsible for the following:


  • Direct technical supervision of the facility and in particular ensures that the medicinal products are handled appropriately.
  • Ensures that the import and wholesale trading in medicinal products are in conformity with the GDP rules described in Annex 4 of MPLO and ensures that the legal provisions applicable to therapeutic products are observed.
  • Is authorised to issue instructions within its sphere of activity.
  • Ensures jointly with the company management its deputization by adequately qualified specialists.
  • If the facilities cease operations, or if operations can be expected to cease imminently, the Responsible Person must report this situation to Swissmedic without delay.
  • May not sit on one of the facilities’ supervisory committees and must decide on the release or rejection of batches independently of the company’s management.
  • Market Release
    • Decides on the market release of a batch before it is placed on the market.
    • Checks and confirms whether:
      • a valid batch certificate issued by the manufacturer is available and whether the batch was manufactured in conformity with the GMP rules described in Annex 1 of MPLO;
      • the batch in question fulfils the requirements of the authorisation;
      • the conditions described in Articles 11 and 12 of MPLO have been fulfilled; and
      • the entire supply chain is in conformity with the authorisation and the GDP rules described in Annex 4 of MPLO.
  • Comply with Swissmedic regulations.

Key Accountabilities And Performance Indicators Include:

  • Ensures that a quality management system is implemented and maintained. Provide QMS support for Switzerland and EU records.
  • Focuses on the management of authorised activities and the accuracy and quality of records.
  • Ensures that initial and continuous training programmes are implemented and maintained.
  • Coordinates and promptly performs any recall operations for medicinal products.
  • Ensures that relevant customer complaints are dealt with effectively.
  • Ensures that suppliers and customers are approved.
  • Approves any subcontracted activities which may impact on GDP.
  • Ensures that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place.
  • Keeps appropriate records of any delegated duties.
  • Decides on the final disposition of returned, rejected, recalled or falsified products.
  • Approves any returns to saleable stock.
  • Ensures that any additional requirements imposed on certain products by national law are adhered to.
  • Notifies Swissmedic according to MPLO Article 41 in case of any amendments to the content of the license or all major changes to facilities, equipment or procedures used for import or wholesale trading with medicinal products and which could influence quality.
  • Reviews and evaluates the Product Quality Reviews of products, for which iNova Pharmaceuticals (Switzerland) AG is Marketing Authorisation Holder, according to swissmedicines inspectorate Technical Interpretation I-SMI.TI.14.
  • Ensure goals and priorities support the business strategic directions.
  • Responsible for Quality management Review (QMR) within a region and support global QMR.
  • Drive consistency and standardization across distribution teams.
  • Responsible to identify, communicate and mitigate quality and compliance performance risk. Lead appropriate oversight of Quality Risk in Supply Chain operations supporting distribution globally.
  • Support audit activities if required.

About You

To be successful in this role, you will possess a tertiary education (university or equivalent / higher technical institute) in the area of natural sciences. Additional requirements include:

  • Technical know-how of the processes a Responsible Person will be responsible for.
  • The Responsible Person should speak the Swiss national language spoken in the company and English.
  • The Responsible Person must live within reasonable distance of the site.
  • At least 5 years’ experience in quality in pharmaceutical industry.
  • Proven track record of knowledge and experience of GMP as well as GDP.
  • Able to handle multiple tasks in a fast-paced environment.
  • Takes initiative and ownership.
  • A problem solver.
  • A blend of technical knowledge and experience and the ability to articulate these needs and their solutions.
  • Be able to work independently and in a team environment across multiple functions and countries.
  • Very good communication skills both written and oral.

Additional Requirements / Working Conditions:

Adhere to company values at all times.

If you wish to be part of an energetic team within a thriving organisation, focused on bringing innovative products to market, please APPLY TODAY We want you to join us in our pursuit of healthy living

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