Responsable Qualité — Roche

CHF 85 500 - 129 500
Roche · Suzhou (BS)
Categoria: Qualità Contratto: full-time Salario: CHF 85 500 - 129 500
Postuler
Lieu
Suzhou
Contrat
full-time
Publié
il y a 55 jours
SalaireCHF 85 500 - 129 500

Vue d’ensemble du poste

At Roche you can show up as yourself, embraced for the unique qualities you bring.

Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally.

This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come.

Responsabilités principales

  • Drive business results and customer value a) Responsible for ensuring that manufactured products in Suzhou meet Health Authority regulations, Notified Body requirements, Company standards and expectations.
  • Establish and support inspection readiness to ensure successful outcomes.

Entreprise et contexte

  • Prepare adequate and timely responses to any inspection observations and implement appropriate and thorough corrections, as necessary. b) Engage and influence the organization to ensure that Product Quality is our focus by ensuring that products manufactured in Suzhou meet regulatory requirements and product specifications.
  • Works directly in a complex, global environment with the chapters and the other Network Leads to deliver high quality products, ensure our right to operate and continuously improve. c) Provide leadership and guidance to staff directing Quality functions, manage performance and development of direct reports to ensure achievement of organizational, and departmental goals and a productive environment. d) Maintain an effective Quality governance and continually improve the governance to meet business and compliance needs.
  • Communicate significant quality or regulatory issues and risks that may impact product quality or regulatory compliance in a timely manner to Executive Management. e) Develop annual budget, revise forecasts to meet business needs and monitor/control expenditures to assure efficient use of company resources. f) Appointed as the Site Management Representative and Person Responsible for Regulatory Compliance (PRRC) equivalent under China Medical Device GMP regulations and international standards (e.g., ISO 13485:2016).
  • Accountable for ensuring the site’s technical documentation, quality management systems, and regulatory filings are meticulously drawn up, maintained up-to-date, and fully aligned with NMPA, FDA, and European regulations to safeguard our right to operate. 2.
  • Advance the work of the Network, making tradeoffs and breaking silos a) Partner with the Operations Site Head on strategic business direction and decisions.
  • Break down silos and improve working effectiveness as an “integrator” across the organization as needed; in particular through collaboration with other Networks Leaders and stakeholders to resolve escalated bottlenecks and dependencies, as well as rebalance work & help in line with greater strategic priorities. b) Build and maintain strong partnerships with other site and network leaders to assure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationships. c) Coordinate with Functional Partners to aggregate upcoming LCTs’ needs and upcoming priorities, to better understand upcoming resource demands on the Network.
  • Empower and enable the Network a) Develop and communicate organizational strategies, which ensure the GMP compliance of the site, continuous improvements and achievement of long-term goals. b) Negotiate with Senior Leadership across the organization to influence decision making. c) Lead,

Détails supplémentaires

  • You serve as a key member of the Global perations Quality Leadership Team (GOQLT) and the Site Leadership Team, modeling Agile behaviors and driving operational excellence.
  • Responsibilities: Drive business results and customer value a) Responsible for ensuring that manufactured products in Suzhou meet Health Authority regulations, Notified Body requirements, Company standards and expectations.

Notes et contenu original

  • Main Tasks &
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Questions sur cette offre

Quel salaire propose Roche pour ce poste ?

Roche indique CHF 85 500 - 129 500 bruts par an pour ce poste à Suzhou. Il s'agit du salaire publié dans l'annonce d'origine (ou, si l'employeur ne précise pas de montant, d'une estimation réaliste pour le rôle et le secteur) — le calculateur de ce site le convertit en net réel une fois l'impôt frontalier et les cotisations sociales appliqués.

Est-ce un poste à temps plein, et quel type de contrat propose Roche ?

Cette offre est un poste en temps plein. Le type de contrat affiché ici provient directement de l'annonce originale de l'employeur ; confirmez toujours les horaires exacts, le préavis et la durée d'essai avec Roche pendant le processus de candidature, ces détails pouvant varier même au sein de la même catégorie de contrat.

Ai-je besoin d'un permis de frontalier pour un poste dans le canton de Bâle ?

Les résidents UE/AELE domiciliés dans la zone frontalière du pays voisin du canton de Bâle peuvent demander un permis G ; l'employeur suisse le dépose auprès de l'office cantonal des migrations après signature du contrat. Les règles de zone frontalière et les délais varient selon le pays voisin et le canton — confirmez les détails auprès de l'office des migrations du canton de Bâle ou avec les RH pendant la candidature.

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