20 beste Stellen als process expert in basel, bs – aktuell auf Personalsuche

Senior Manager, GCP Inspection Lead
BeiGene —Basel, BS
- CHF 141’800 - CHF 177’300 pro Jahr
- 100%
- Englisch
- Microsoft Office
- PC-Kenntnisse
Research Associate – Organic Synthesis.
SpiroChem AG —Basel, BS
- Doktorat
- Laborerfahrung
- Englisch
Integrated Medical Engagement Change Management Lead
Roche —Basel, BS
- 100%
- Doktorat
- Projektmanagement
- Ohne Hochschulabschluss
Senior Process Automation Engineer (DSP) (a), 100%
Bachem Holding AG —Stein AG, AG
- 100%
- Englisch
- Forschungserfahrung
- SPS-Steuerung
11 Tage
Key Account Manager (f/m/d) - Biopharma
Avantor —Basel, BS
- 100%
- Englisch
- Projektmanagement
- Erfahrung mit Netzwerken
Innovative Process Technician
Ecolab —Witterswil, SO
- 100%
- Englisch
- Bachelor
- Produktion
- Aufstiegsmöglichkeiten
Predictive Business Steering - GPM (m/f/d)
Bayer —Basel, BS
- Kommunikationsfähigkeit
Post-Doc-Wissenschaftler
Roche —Basel, BS
- 100%
- Doktorat
Global Ecosystem Insights Beyond TA Market Insights Leader
Roche —Basel, BS
- 100%
- Forschungserfahrung
- Analysefähigkeit
- Bachelor
12 Tage
Principal, Health Economics, Health Technology Assessment
IQVIA —Basel, BS
- 100%
- Microsoft Excel
- Master
- Erfahrung mit Netzwerken
13 Tage
Senior Group Director, Safety Development & Processes
Roche —Basel, BS
- 100%
- Master
- Betriebswirtschaftslehre
- Führungserfahrung
5 Tage
Head of Medical Affairs IOMH (m/f/d)
Boehringer Ingelheim (Schweiz) GmbH —Basel, BS
- 100%
- Homeoffice
- Englisch
- Führungserfahrung
- Kommunikationsfähigkeit
Data scientist in Oncology
Universität Basel —Basel, BS
- 100%
- Doktorat
- Datenanalyse
- Englisch
Global OE Specialist - Lean (a), 100%
Bachem Holding AG —Bubendorf, BL
- 100%
- Management-Erfahrung
- Englisch
- Forschungserfahrung
Global Ecosystem Insights Beyond TA Insights Product Enablement Leader
Roche —Basel, BS
- 100%
- Forschungserfahrung
- Analysefähigkeit
- Bachelor
12 Tage
Global Category Lead, Capital Equipment
Fresenius Medical Care —Basel, BS
- 100%
- Management-Erfahrung
- Englisch
- Microsoft Office
Associate Director - HNC Regional Science EMEA
dsm-firmenich —Kaiseraugst, AG
- Doktorat
- Englisch
- Master
4 Tage
Global Ecosystem Insights Beyond TA Portfolio Insights Leader
Roche —Basel, BS
- 100%
- Forschungserfahrung
- Analysefähigkeit
- Bachelor
12 Tage
MSAT Technical Lead - Drug Substance - Biologics
Sobi —Basel, BS
- 100%
- Hybrides Arbeiten
- Management-Erfahrung
- Englisch
- Produktion
Direkt bewerben
Senior Statistical Methodology Data Scientist
Genentech —Basel, BS
- 100%
- Doktorat
- Mentoring
6 Tage

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Senior Manager, GCP Inspection Lead

BeiGene -
Basel, BS

Jetzt bewerben

Details zur Stelle

100% | Pensum: 90-100%
CHF 141’800 - CHF 177’300 pro Jahr

Qualifikationen

Englisch
Microsoft Office
Qualitätssicherung
PC-Kenntnisse
Kommunikationsfähigkeit

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.

Reporting to the Senior Director, Global GCP Inspection Management, R&D Quality, the Senior Manager, Inspection Management serves as an inspection lead with primary responsibility for Health Authority GCP inspection readiness across cross‑functional clinical study teams. This role oversees end‑to‑end inspection planning and execution, including inspection logistics, stakeholder coordination, and continuous process improvements, to ensure research and development activities comply with applicable global regulatory requirements, guidelines, laws, and internal standards and practices.

Essential Functions of the job:

Lead and oversee GCP Inspection readiness activities and serve as inspection lead for regulatory Health Authority inspections, including but not limited to FDA, MHRA, EMA, CFDI, MFDS, PMDA, TGA, and TFDA.
Collaborate with cross-functional clinical study teams to develop and execute an integrated, risk‑based inspection readiness strategy, ensuring consistent alignment across functions.
Manage end‑to‑end inspection readiness activities, including development and maintenance of inspection storyboards with subject matter experts (SMEs), proactive identification and mitigation of inspection‑related risks, and planning, facilitation, and leadership of mock inspections and Health Authority inspections.
During regulatory inspections, coordinate and assign inspection requests to appropriate SME), providing oversight and guidance to ensure accurate, timely, and effective responses.
Create/revise appropriate SOPs and tools for inspection readiness and management.
Implement and maintain key QA systems, including investigations, Significant Quality Events (SQEs), Deviations, and CAPAs.
Demonstrate ability to solve complex problems requiring in-depth evaluation of various factors.
Fulfill all inspection commitments, respond to inspections, and carry out post-inspection activities, corrective and preventative actions, and resolve any issues for timely closure.
Manage a central repository of global inspection status and updates.
Meticulous attention to detail, excellent reviewing skills, and ability to independently manage multiple tasks in a fast-paced environment.
Support/manage Site Inspection Preparation Visit (SIPV) at investigative sites.
Lead and facilitate post-inspection lessons learned sessions to trends, share best practices, and drive sustainable process improvements.
Demonstrate the ability to define strategic direction and lead initiatives that enhance quality systems, inspection readiness, and overall operational excellence.
Exhibit strong leadership capabilities, including the ability to mentor, coach, and develop team members and cross‑functional partners.
Possess a thorough understanding of global regulatory requirements and guidelines governing the conduct of clinical trial operations across multiple regions.

Supervisory Responsibilities:

Not Applicable

Computer Skills: All basic Microsoft Office Programs

Other Qualifications:

+7 years of experience in GCP-related Quality Assurance function of the pharmaceutical, biotechnology or related health care industry.
High level of understanding of international GCP requirements and standards in the pharmaceutical, medical device and biotech industries.
Excellent English language skills, and additional language depending on locations and need.
Excellent verbal and written communication skills
Ability to effectively collaborate in a dynamic environment.

Travel:

Flexible to travel, including international.
May require up to 35% travel, sometimes with short notice time.

Salary Range Switzerland: 141,800.00 CHF - 177,300.00 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

process expert Jobs in basel, bs

Senior Manager, GCP Inspection Lead

Research Associate – Organic Synthesis.

Integrated Medical Engagement Change Management Lead

Senior Process Automation Engineer (DSP) (a), 100%

Key Account Manager (f/m/d) - Biopharma

Innovative Process Technician

Predictive Business Steering - GPM (m/f/d)

Post-Doc-Wissenschaftler

Global Ecosystem Insights Beyond TA Market Insights Leader

Principal, Health Economics, Health Technology Assessment

Senior Group Director, Safety Development & Processes

Head of Medical Affairs IOMH (m/f/d)

Data scientist in Oncology

Global OE Specialist - Lean (a), 100%

Global Ecosystem Insights Beyond TA Insights Product Enablement Leader

Global Category Lead, Capital Equipment

Associate Director - HNC Regional Science EMEA

Global Ecosystem Insights Beyond TA Portfolio Insights Leader

MSAT Technical Lead - Drug Substance - Biologics

Senior Statistical Methodology Data Scientist

Ich möchte aktuelle Job-E-Mails für Stellen als process expert in basel, bs erhalten

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