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

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.

Responsibilities:

CDMO & Vendor Quality Oversight

Primary GMP/GDP Quality contact for identified vendors (DS & DP) supporting clinical programs; day-to-day quality interface.
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
Ability to travel up to ~15% to CDMOs

Jetzt bewerben

Erweiterte Suche

quality control Jobs in basel bs

Manager / Sr. Manager – Quality GMP

Workshop Technician

QA/QC Engineer (Junior / Professional)

Forum Basiliense Junior Fellows

Global Microbial Supply Chain & Industrialization Manager

Architects and Designers

Cabin Installation Supervisor - Business Jets Completions

Verification & Validation Engineer

QRC Manager (m/f/d)

Lab Technician QC - Late Phase 100% (a)

Aircraft Avionics Technician

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

Technical Project Manager (m/f/d)

Laboratory Technician in Physics

Laboratory Technician in Physics

ICT System Specialist, Network & Infrastructure (80-100%)

Senior/Principal Steward for Engineering Standards

MES System Engineer (a), 80 - 100%

CFO (Chief Financial Officer) - SME

PhD Student in Forecasting Resistance Spread and Epidemiological Impact (100%)

Ich möchte aktuelle Job-E-Mails für Stellen als quality control in basel bs erhalten

Related Searches

Weitere Job-Standorte erkunden

Tools für Jobsuchende

Arbeitgebertools

Durchsuchen

Bleiben Sie in Kontakt