20 beste Stellen als of quality assurance in basel bs – aktuell auf Personalsuche

Director, QMS BPO, Quality Issue Escalation, Risk & Knowledge
BeiGene —Basel, BS
- 100%
- Microsoft Powerpoint
- Microsoft Excel
- Microsoft Outlook
Manager / Sr. Manager – Quality GMP
Monte Rosa Therapeutics, Inc —Basel, BS
- CHF 115’000 - CHF 140’000 pro Jahr
- 100%
- Spanisch
- Englisch
Title Quality Assurance Manager CH & AT (m/w/d) FvP und fachkundige Person
Recordati —Basel, BS
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- Englisch
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Fachhochschule Nordwestschweiz FHNW —Muttenz, BL
- Teilzeit
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- Informatik
- Englisch
- Forschungserfahrung
- Weiterbildungen
14 Tage
Internal Auditor/Internal Audit Manager (with experience in Operations and/or Project Management)
Lonza —Basel, BS
- 100%
- Management-Erfahrung
- Englisch
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RiSM Internship for Students supporting Compliance and Data Integrity in Pharma (Basel, 9-12 months)
Roche —Basel, BS
- 100%
- Microsoft Powerpoint
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Swiss AviationSoftware —Allschwil, BL
- Informatik
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- Bachelor
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Sobi —Basel, BS
- 100%
- Hybrides Arbeiten
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Intertek Holding Deutschland GmbH —Reinach, BL
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Idorsia Pharmaceuticals Ltd. —Basel, BS
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Advanced CSV Consultants – Raum Basel
NNIT A/S —Basel, BS
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Bruker —Füllinsdorf, BL
- 100%
- Gastgewerbe
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NNIT A/S —Basel, BS
- 100%
- Homeoffice
- Englisch
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QA Shopfloor Manager 100% (a)
Bachem Holding AG —Bubendorf, BL
- 100%
- Homeoffice
- Englisch
- Master
- Bachelor
- Pensionskasse

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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

of quality assurance Jobs in basel bs

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

Manager / Sr. Manager – Quality GMP

Title Quality Assurance Manager CH & AT (m/w/d) FvP und fachkundige Person

Sr GVP QA

Operations Associate Life Science

4PL Freight Planner

Sr QA IT/CSV Compliance Specialist

Project Manager for European Digital Innovation Hub (50%-60%)

Internal Auditor/Internal Audit Manager (with experience in Operations and/or Project Management)

RiSM Internship for Students supporting Compliance and Data Integrity in Pharma (Basel, 9-12 months)

Release Manager

Global Quality GVP Manager

Inspector Quality Assurance (m/f/d/x)

Senior QA Compliance & Auditing Manager

Advanced CSV Consultants – Raum Basel

CSV Engineer

Accountant

Frontdesk Manager (m/f/d)

Senior CSV Consultant

QA Shopfloor Manager 100% (a)

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