Head of Quality and Regulatory Affairs

von: Belimed Life Science AG | Ort: Sulgen
N: BelimedLifeScienceAG
Die Belimed Life Science AG ist ein global tätiges Unternehmen mit Hauptsitz in Sulgen, Schweiz. Die Belimed Life Science AG entwickelt, produziert, vertreibt, installiert, modifiziert und optimiert Anlagen zur Reinigung und Sterilisation in den Anwendungsbereichen: Pharma, Biopharma, Life Science und Kosmetika für Labor- und Produktionsapplikationen. Mit Retrofitlösungen für bestehende Anlagen, der Entwicklung von Zubehör und weitreichende Qualifizierungstätigkeiten runden wir unser Dienstleistungsportfolio ab. Den aktuellen neuen Herausforderungen der Branche für eine schnelle Entwicklung von Impfstoffen und Medikamenten und der notwendigen Sicherstellung der Qualität von diesenpharmazeutischen Endprodukten werden wir mit neuen, innovativen Lösungen auf höchstem Niveau gerecht. Nach der erfolgten Ausgründung am 01.04.2019 aus der Belimed AG haben wir aktuell mehr als 350 Spezialisten an zwei Standorten in Sulgen (CH) und in Grosuplje (SI).Lust auf Arbeiten mit heissem Dampf und reinstem Wasser? Dann bewerben Sie sich bei uns als:

Head of Quality and Regulatory Affairs

The Head of Quality is the direct contact person with regard to the department he or she heads. Implements and manages the quality processes and management systemof "Belimed Life Science AG". Ensures that the organization is aware of the requirements under EN ISO 13485 and the general GMP requirements according to FDA guideline. Takes responsibility for handling non-compliant products and complaints and coordinates appropriate corrective and preventive actions. Acts as a contact person regarding quality (management) for customers and suppliers. Tasks:

  • Implementation of corporate strategy and corporate goals
  • Supports the organization in implementing and managing required quality processes.
  • Defines the certification strategy in cooperation with the CEO and coordinates the certification of the quality management system with the notified body.
  • Ensures that the organization is aware of life science-specific requirements such as material declaration and verification, GMP processes, FAT/SAT procedures, validation, etc.
  • Supports the organization in determining an appropriate level of training in the Life Science business area according to customer needs.
  • Supports the organization in ensuring the conformity of distributors and subcontractors, e.g. certification, level of training, contractual issues (regulatory matters).
  • Coordinates and handles nonconformities and investigations, ensures the effectiveness of corrective and preventive actions.
  • Supports customer complaint management.
  • Determines whether quality controls are effective.
  • Coordinates and implements pressure equipment approvals for new products and/or in new countries.
  • Develops and reports on the required "Life Science AG" quality performance indicators (KPIs)
  • Acts as a point of contact with customers for quality-related concerns (e.g. supplier questionnaires, desktop and on-site audits); Coordination of customer audits with suppliers of outsourced processes.
  • Conducts internal audits and supplier audits (e.g. subcontractors)
  • Definition, introduction and revision of company-specific quality documents and process instructions.
  • Support the implementation of change orders.
  • Is the responsible person in the implementation of 8D Reports.

Responsibilities:

  • The quality management system of "Belimed Life Science AG" has been introduced and still has to be implemented and managed by the QM manager
  • Role of QA: Decides on FAT release, delivery, concessions and delivery stops
  • Releases type plates in cooperation with engineering (e.g. Test mark)
  • Drafted the Declarations of Conformity (countersignature)together with the Head of Engineering
  • Leads the QA team at all Belimed Life Science sites
  • Competencies in accordance with the Articles of Association and management guidelines (leadership and business competencies) of Belimed Life Science AG.
  • Is empowered to establish non-conforming conditions in internal and external audits and reviews and to agree on corrective actions.
  • In case of quality deviations: Is authorized to prohibit work and/or delivery, as well as to initiate permanent corrective actions inside or outside (suppliers, outsourced processes, customer installations) of the organization.
  • In such cases, there is an obligation to inform the CEO and the relevant bodies.

Abilities:

  • Strong interpersonal and communication skills
  • An independent, honest person who understands business, customer and regulatory requirements, requests and expectations and can communicate them to stakeholders.
  • A structured and systematic way of working.
  • Coaching and leadership; Working in an interdisciplinary team
  • Result-oriented and focused on the defined goals.
  • Readiness for supplier (outsourced processes) and customer visits (10%-20%)

Experience:

  • Bachelor's degree in (Electrical Engineering or Mechanical Engineering)
  • At least 5 years of relevant professional experience in the life science sector
  • German as mother tongue, English at advanced C1 level
  • Proven, several years of experience as a quality manager or in a leading rolewithin a quality assurance organization.
  • Guidelines, regulations, and standards for life sciences, e.g. EN ISO 13485, GMP, …
  • Expertise in regulations and standards in the field of pressure equipment, sterilization and washing/disinfection technologies is desirable.
  • MS Office (required), SAP or similar ERP systems (advantageous)

Take on a central role in a dynamic international company. With us, you can expect a varied and exciting job in a complex field. Interested in this challenge? Then we look forward to receiving your application documents (CV, letter of motivation and references) via our careers page.

Wir prüfen gerne Dossiers von Personalstellenvermittlern, unter der Bedingung, dass die Geschäftsbedingungen für die Vermittlung in jedem Fall individuell verhandelt werden. Allgemeine Konditionen werden nicht anerkannt.

N: BelimedLifeScienceAG

  • Sulgen

Webseite Belimed Life Science AG

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