6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of……
Minimum 10 years of experience in Pharmacovigilance within the pharmaceutical or biotechnology industry. Understanding of adverse event reporting requirements……
Proven experience as quality or safety manager. Inspect premises and the work of personnel to identify issues or non-conformity (e.g. not using protective……
Orientation résultats, capacité à structurer, prioriser et livrer dans un environnement exigeant. Minimum 10 ans d’expérience en Assurance Qualité en……
Taking responsibility for the development of programme's content, teaching methods and the curriculum, quality assurance and resource planning as well as for……
Ability to work closely with operational teams in manufacturing and laboratory areas. As a Quality Pharma Specialist, you are responsible for compliance……
This role provides leadership for nonconformance investigations, production quality support, and sterility assurance activities to maintain product quality,……
At least 5 years of experience in Quality Assurance, Quality Management Systems (QMS), and/or Compliance Management, ideally within a GMP-regulated……
The work location will be Bern or Lausanne, with frequent travel abroad and maximum of 35% home office. Leadership & Collaboration: Demonstrated success in……
GMP Batch Record and Product or Program Document: reviewing executed batch records (paper and electronic), product or program specific documents, deviation and……
Language Skills: Proficiency in German (min. C1 Level) and good English skills (written and spoken) are mandatory for international visitor contact and system……
Reporting to the Senior Director, Global GCP Inspection Management, R&D Quality, the Senior Manager, Inspection Management serves as an inspection lead with……
Gemeinsam leisten wir täglich einen Beitrag für unsere Vision „Wir bringen Leichtigkeit in Ihr Zuhause und Kreativität in Ihre Küche“. Darauf sind wir stolz.…
Our flexible working practices help you optimize personal and business performance while creating an environment where all employees can develop their skills……
Strong experience in all CAPEX project activities required to scope, develop, procure, construct and qualify new equipment and facilities required to meet……
Implement aspects of production quality assurance and document control activities to ensure compliance with internal procedures and international regulations.…
Le/La Superviseur·se de Laboratoire QC Physico-Chimie est responsable des activités opérationnelles de contrôle qualité physico-chimique liées à la substance……
The state-of-the-art facilities on the USB campus provide all DBM researchers with access to a fully GMP-compliant environment for ATMP manufacturing and……
La Segreteria di Stato dell'economia (SECO) è il centro di competenza della Confederazione per tutte le questioni inerenti alla politica economica e del lavoro……
Zur Verstärkung unseres Teams in Kriens suchen wir per sofort oder nach Vereinbarung eine selbständige Persönlichkeit als. ZFP-Ausbildung VT, PT, MT, mind.…
You'll collaborate with cross-functional teams to drive continuous improvement initiatives, lead investigations, and implement corrective actions to maintain……
Conducting inspections at suppliers’, customers’, or transit locations within the assigned region. Conducting visual quality inspections of goods, materials,……
The Manager, GMP Quality is responsible for the oversight and day-to-day quality interface with CDMO producing DS & DP for MRTx's ongoing clinical programs.. This includes supporting the review of MBRs/EBRs, analytical methods, validation protocols/reports, specifications, release data packages and stability protocols/report. This role will also supportextneral audits , inspection readiness and regulatory authority inspections.
Support new vendor qualification, audits and Quality Technical Agreements (QTAs) management.
Monitor vendor compliance; escalate risks to Sr. Leadership in a timely, structured manner.
Documentation & Quality Systems
Author and maintain GMP/GDP SOPs with a phase-appropriate approach; develop and provide cGMP and other GxP training, as appropriate.
Provide risk-based GMP impact assessments aligned with international regulations
Quality Assurance and Analytical GMP responsibilities
Review MBRs/EBRs, analytical methods, validation protocols/reports, specifications, release data packages and stability protocols/reports
Support clinical batch release/disposition in collaboration with CMC and Supply Chain
Manage / Lead internal and external quality events (e.g. change controls, deviations, troubleshooting, investigations, CAPAs) and ensure timely closure; proactively flag overdue items
Regulatory & Compliance
Provide Quality input to CMC sections of regulatory submissions
Support inspection readiness activities; assist in preparation and remediation of audit responses.
Maintain GDP compliance for clinical trial material distribution; support cold chain oversight.
Qualifications:
6 years’ experience with a MS (organic chemistry, biology, analytic or related life science); and includes progressively more responsible QA and analytical related scientific/technical discipline or equivalent combination of education and relevant experience in the pharmaceutical industry, related GMP environment
Hands-on External Quality oversight for clinical phase, extensive QMS experience. Familiarity with QP batch certification (EU Annex 16) and GDP Responsible Person role is an advantage
Deep understanding of analytical and QC operations, CMC, regulatory requirements, and best industry practices with proven matrix leadership in managing cross-functional teams
Recognized as a subject matter expert within the organization, with the ability to solve advanced GxP problems and guide others
Proficiency with electronic QMS platforms (e.g. Veeva Vault, MasterControl or equivalent)
Start-up or lean-team experience; operates without extensive infrastructure
Fluent English required; German, French and/or Spanish is an advantage
Das Mindestgehalt beträgt CHF 115'000 und das Höchstgehalt CHF 140'000.
CHF 115'000 – CHF 140'000/J (Arbeitgeberangabe)
CHF 127'500
/Jahr (Mittelwert)
Basel
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