20 beste Stellen als director of quality in stein, ag – aktuell auf Personalsuche

Director, QMS BPO, Quality Issue Escalation, Risk & Knowledge
BeiGene —Basel, BS
- 100%
- Microsoft Powerpoint
- Microsoft Excel
- Microsoft Outlook
Senior Director, Global Head of Client Services - Clinical Trials Division
Thermo Fisher Scientific —Basel, BS
- CHF 157’700 - CHF 236’525 pro Jahr
- 100%
- Projektmanagement
- Bachelor
- Führungserfahrung
- Bezahlte Feiertage
- Bezahlte Ferien
Executive Director, Quality Site Head Stein
Lonza —Stein, AG
- 100%
- Master
- Elektronisches Patientendossier
- Produktion
13 Tage
Associate Director QA - Growth Project 80-100%
Lonza —Stein, AG
- Management-Erfahrung
- Englisch
- Bachelor
- Umzugskostenzuschus
Associate Director, Program and Alliance Management - Discovery to Phase II
Monte Rosa Therapeutics, Inc —Basel, BS
- CHF 145’000 - CHF 170’000 pro Jahr
- 100%
- Doktorat
- Forschungserfahrung
- Microsoft Office
Senior Director, Medical Affairs, Hemato-Oncology, Europe
BeiGene —Basel, BS
- CHF 251’100 - CHF 313’900 pro Jahr
- 100%
- CRM-Software
- Doktorat
- Bis zu 50% Reiseanteil
11 Tage
Director, Medical Affairs, Hemato-Oncology, Europe
BeiGene —Basel, BS
- CHF 209’300 - CHF 261’600 pro Jahr
- 100%
- CRM-Software
- Doktorat
- Bis zu 50% Reiseanteil
11 Tage
Associate Director, Good Clinical Practice (GCP) Audit and Vendor Management
BeiGene —Basel, BS
- 100%
- Homeoffice
- Microsoft Powerpoint
- Microsoft Excel
- Microsoft Outlook
Director, Strategic Sourcing
Thermo Fisher Scientific —Allschwil, BL
- 100%
- Homeoffice
- Management-Erfahrung
- Englisch
- Analysefähigkeit
Associate Director, Commercial Insights and Analytics
BeiGene —Basel, BS
- 100%
- Englisch
- Microsoft Office
- SQL
Associate Director, Technology Transfer 80-100%
Lonza —Stein, AG
- Doktorat
- Englisch
- Bachelor
- Umzugskostenzuschus
Senior Regulatory Group Director
Roche —Basel, BS
- 100%
- Microsoft Excel
- Management-Erfahrung
- Master
1 Tag
Associate Director, Technical Project Leader Drug Substance
Idorsia Pharmaceuticals Ltd. —Basel, BS
- 100%
- Doktorat
- Englisch
- Master
Senior Manager Global QMS Transformation (a) - 100%
Bachem Holding AG —Bubendorf, BL
- Homeoffice
- Management-Erfahrung
- PMP
- Forschungserfahrung
- Pensionskasse
Biostatistics Director
Neurocrine Bioscience —Allschwil, BL
- 100%
- Doktorat
- Datenanalyse
- Forschungserfahrung
Executive Director, Regulatory Strategy
Neurocrine Bioscience —Allschwil, BL
- 100%
- Management-Erfahrung
- Doktorat
- Master
Title Clinical Development Manager - Endocrinology
Recordati —Basel, BS
- 100%
- Management-Erfahrung
- Datenanalyse
- Englisch
Executive Director, IT Business Partner – Advanced Synthesis
Lonza —Basel, BS
- 100%
- Management-Erfahrung
- Master
- Analysefähigkeit
11 Tage
Principal, Strategic Advisory Consulting (Life Sciences Supply Chain & Operations)
IQVIA —Basel, BS
- 100%
- Management-Erfahrung
- Englisch
- Master
Sr. Director, Global Immunology Franchise
Alfasigma Group —Basel, BS
- Management-Erfahrung
- Erfahrung in der IT
- Führungserfahrung

Ich möchte aktuelle Job-E-Mails für Stellen als director of quality in stein, ag erhalten

Wenn Sie sich bei Ihrem Konto anmelden, stimmen Sie den Nutzungsbedingungen, den Richtlinien zur Verwendung von Cookies sowie der Datenschutzerklärung von SimplyHired zu.

Weitere Job-Standorte erkunden

director of quality jobs near stein, ag

Jobs als Director Of Quality in Basel, BS

Jobs als Group Leader in Basel, BS

Jobs als Project Leader in Basel, BS

Jobs als Life Science Consultant in Basel, BS

Jobs als Healthcare Project Management in Zürich, ZH

Jobs als Director Of Program Management in Zürich, ZH

Jobs als Director Of Program Management in Baar, ZG

Jobs als Program Manager in Zürich, ZH

Jobs als Supply Chain Director in Canton Of Schaffhausen

Jobs als Supply Chain Director in Fribourg, FR

Jobs als Senior Director in Zug, ZG

Jobs als Supply Chain Director in Altdorf, UR

Jobs als Commercial Director in Zürich, ZH

Jobs als Creative Director in Genève, GE

Jobs als Director in Geneva, GE

Jobs als Director Pharma in Basel, BS

Jobs als Digital Transformation Consultant in Zürich, ZH

Jobs als Transformation Manager in Zoug, ZG

Jobs als Transformation Manager in Basel, BS

Jobs als Project Manager in Basel, BS

Director, QMS BPO, Quality Issue Escalation, Risk & Knowledge

BeiGene -
Basel, BS

Jetzt bewerben

Details zur Stelle

100% | Pensum: 90-100%

Qualifikationen

Microsoft Powerpoint
Power BI
Microsoft Excel
Microsoft Outlook
Management-Erfahrung
Textverarbeitung
SAP
Biotechnologie
Microsoft Office
Master
Bachelor
PC-Kenntnisse
Qualitätssysteme
Führungserfahrung

Vollständige Stellenbeschreibung

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

The QMS Business Process Owner is responsible for managing assigned escalated GxP and Quality incidents in an end-to-end process on global level, initiating GxP/Quality incident prevention measures and maintaining (incl continuous improvement) of defined incident management related processes within regulated environments on global level. GxP (Good Practices) guidelines are critical for ensuring product quality, safety, and regulatory compliance in the pharmaceutical / life sciences sector. As BPO, the Director leads and oversees that quality incidents are managed effectively, root causes are identified, lessons learned are issued, and corrective and preventive actions (CAPAs) are developed to maintain the highest standards of compliance and patient safety and that the process operates for all BeOne operational groups.

As BPO for Quality Risk Management (QRM) frameworks, ensuring compliance with regulatory requirements (e.g., ICH Q9). Serve as a Subject Matter Expert (SME) and Facilitator for quality risk assessment, investigations, change control, and resolution of complex quality issues including review of regulatory CMC submission content.

Further, this position will build and grow the knowledge management processes and tools to enable rapid access to data and knowledge over the entire product lifecycle in collaboration with the Product Data Quality team.

This role requires a blend of technical expertise, leadership skills, and a proactive approach to quality and risk management as well as to continuous improvement.

Essential Functions of the Job:

Processes: Develop, maintain and implement assigned GxP/Quality incident management processes that align with organizational goals and latest regulatory requirements on global level.
Manage and oversee the intake, triage, investigation, documentation, and resolution of GxP and quality-related issues and incidents in an end-to-end process, including resulting from deviations, regulatory and/or GxP non-conformances or other quality events.
Cross-Functional Collaboration: Partner with manufacturing, quality assurance, quality control, regulatory affairs, clinical operations, development, patient safety and other stakeholders to ensure timely and thorough management of GxP and quality incidents.
Root Cause Analysis and CAPA management: Drive and support comprehensive root cause investigations. Drive and oversee the development of corrective and preventive actions plans and lessons learned related to escalated GxP and Quality incidents. Drive initiation and execution of market actions, if required.
Regulatory and GxP Compliance: Ensure that the Escalation and Notification to Management related activities and documentation meet the relevant regulatory agency and other relevant requirements for the industry (FDA, EMA, any local regulations, ISO, WHO); prepare for and support inspections and audits.
Training & Communication: Develop and deliver training on incident management procedures, share lessons learned from managed GxP/Quality incidents and promote a culture of quality and accountability across the organization.
Metrics & Reporting: Ensure meeting of key performance indicators (KPIs), track incident trends, and provide regular reports.

Education and Experience Required:

Bachelor’s degree and 8+ years of experience in quality sciences, quality systems, or related fields within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices).
Master’s degree and 10+ years direct experience preferred

Supervisory Responsibilities:

6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.

Computer Skills:

Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint). Ability to learn specialized platforms (Veeva, Power BI, Calyx, SAP, etc)

Other Qualifications:

Experience with regulatory interactions including notification and communication with health authorities on global level for sensitive compliance topics.

Travel: Up to 20%

Salary Range Switzerland: 178,600.00 CHF - 223,300.00 CHF

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

Fosters Teamwork
Provides and Solicits Honest and Actionable Feedback
Self-Awareness
Acts Inclusively
Demonstrates Initiative
Entrepreneurial Mindset
Continuous Learning
Embraces Change
Results-Oriented
Analytical Thinking/Data Analysis
Financial Excellence
Communicates with Clarity

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

Jetzt bewerben

Erweiterte Suche

director of quality Jobs in stein, ag

Director, QMS BPO, Quality Issue Escalation, Risk & Knowledge

Senior Director, Global Head of Client Services - Clinical Trials Division

Executive Director, Quality Site Head Stein

Associate Director QA - Growth Project 80-100%

Associate Director, Program and Alliance Management - Discovery to Phase II

Senior Director, Medical Affairs, Hemato-Oncology, Europe

Director, Medical Affairs, Hemato-Oncology, Europe

Associate Director, Good Clinical Practice (GCP) Audit and Vendor Management

Director, Strategic Sourcing

Associate Director, Commercial Insights and Analytics

Associate Director, Technology Transfer 80-100%

Senior Regulatory Group Director

Associate Director, Technical Project Leader Drug Substance

Senior Manager Global QMS Transformation (a) - 100%

Biostatistics Director

Executive Director, Regulatory Strategy

Title Clinical Development Manager - Endocrinology

Executive Director, IT Business Partner – Advanced Synthesis

Principal, Strategic Advisory Consulting (Life Sciences Supply Chain & Operations)

Sr. Director, Global Immunology Franchise

Ich möchte aktuelle Job-E-Mails für Stellen als director of quality in stein, ag erhalten

Related Searches

Weitere Job-Standorte erkunden

Tools für Jobsuchende

Arbeitgebertools

Durchsuchen

Bleiben Sie in Kontakt