External Quality is an agile organization that excels in quality and risk management, through building links with our internal team members and external partners.
Locations (3)
Allschwil, Basel-Country, Switzerland
Beerse, Antwerp, Belgium
Latina, Italy
Responsibilities
Provide quality assurance support and oversight for external Synthetics manufacturing operations, including commercial manufacturing, packaging, testing, release, stability and related supply activities.
Review, coordinate and provide quality concurrence or approval, as applicable, for deviations, non-conformances, investigations, CAPAs, change controls, complaints, product disposition records, manufacturing instructions, specifications, validation documentation, technical studies and quality agreements.
Monitor quality and compliance performance of assigned external manufacturers using quality metrics, risk ratings, audit outcomes, inspection history, supplier performance data and issue trends.
Identify, communicate and elevate quality, compliance or supply risks in a timely manner and support practical, risk-based mitigation and remediation plans.
Support qualification, ongoing monitoring and lifecycle management of external manufacturers and strategic partners in alignment with External Quality processes.
Requirements
Bachelor’s degree or equivalent university degree in Pharmacy, Science, Engineering or a related technical discipline
The anticipated base pay range for this position is:
€49’100.00 - €78’200.00
Responsibilities
Provide quality assurance support and oversight for external Synthetics manufacturing operations, including commercial manufacturing, packaging, testing, release, stability and related supply activities.
Review, coordinate and provide quality concurrence or approval, as applicable, for deviations, non-conformances, investigations, CAPAs, change controls, complaints, product disposition records, manufacturing instructions, specifications, validation documentation, technical studies and quality agreements.
Monitor quality and compliance performance of assigned external manufacturers using quality metrics, risk ratings, audit outcomes, inspection history, supplier performance data and issue trends.
Identify, communicate and elevate quality, compliance or supply risks in a timely manner and support practical, risk-based mitigation and remediation plans.
Support qualification, ongoing monitoring and lifecycle management of external manufacturers and strategic partners in alignment with External Quality processes.
Requirements
Bachelor’s degree or equivalent university degree in Pharmacy, Science, Engineering or a related technical discipline.
CQV Specialist ensures control, compliance, availability, and integrity of GMP‑required documentation to maintain regulatory compliance and operational traceability.
Responsibilities
Draft and maintain Standard Operating Procedures (SOPs)
Senior Automation Engineer will lead internal team members, suppliers, OEMs, system integrators, Digital/IT partners, automation-system owners, and cross-functional stakeholders to deliver OT infrastructure, industrial networking, integration, historian, virtualization, cybersecurity, and lifecycle initiatives in a cGMP manufacturing environment.
Responsibilities
Lead internal team members, suppliers, OEMs, system integrators, Digital/IT partners, automation-system owners, and cross-functional stakeholders to deliver OT infrastructure, industrial networking, integration, historian, virtualization, cybersecurity, and lifecycle initiatives in a cGMP manufacturing environment.
Own vision requirements and inspection specifications across filling, AVI, device assembly, and packaging.
Define inspection scope and measurable acceptance criteria with Quality and equipment specialists, resolving supplier and integration gaps.
Specify, configure, and troubleshoot cameras, lenses, illumination, exposure, triggering, and image geometry.
Establish stable image acquisition across product formats, equipment speeds, and expected variation in materials and presentation.
Senior technical leader responsible for investigation oversight and analytical problem‑solving support across the Quality Control organization.
Compensation
$162,000—$175,000 USD
Responsibilities
Oversee QC OOS, OOT, deviations, atypical results, invalid assays, and laboratory investigations across Chemistry, Microbiology, and Raw Materials
Lead or facilitate complex, high‑impact, recurring, or cross‑functional investigations
Ensure investigations include clear problem statements, hypotheses, scientifically justified testing, defensible root causes, product‑impact assessments, and CAPAs where appropriate
Challenge root‑cause conclusions not adequately supported by data
Facilitate root‑cause analysis using 5‑Why, fishbone/Ishikawa, fault‑tree, and FMEA/risk‑based tools
Requirements
Bachelor's degree in Chemistry, Biochemistry, Biology, Microbiology, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline
Nice to have: Master's degree or advanced scientific degree
Support QC testing for in-process, final product, and stability samples, including data review/verification, method transfer, documentation, deviations, investigations, and continuous improvement efforts.
Compensation
Summit West - NJ - US: $34.82 - $42.19per hour
Responsibilities
Perform routine testing of in-process, final product, and stability samples
Perform testing for method transfer/validation/verification
Perform data verification, data review and review of GMP documentation for general methods
May perform document revision, project, CAPA and deviation/ investigation related tasks and/or continuous improvement efforts
Senior Associate Plant QA responsible for providing QA guidance, batch record review, and support for production operations at AOH.
Compensation
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. Salary Range 82,081.95USD -111,052.05 USD
Responsibilities
Provide daily guidance and support to Production staff regarding compliance with SOPs and Work Instructions
Ensure regular presence in device assembly and packaging areas to monitor GMP operations and quality systems
Act as a first point of contact for production queries during packaging and labeling operations
Lead, mentor, and coach Operations and support personnel on quality matters
Review and approve batch production records and other GMP documentation
Requirements
High school/GED + 4 years of Quality and/or GMP Manufacturing experience
Associate’s + 2 years of Quality and/or GMP Manufacturing experience
Bachelor’s + 6 months of Quality and/or GMP Manufacturing experience
Master's
Nice to have: Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing Technologies
Summary
The CQV Specialist ensures the control, compliance, availability, and integrity of all documentation subject to GMP requirements in order to maintain site regulatory compliance and operational traceability. They check that all quality-related documents are created, reviewed, approved, distributed, and archived in accordance with applicable procedures.
Duties and responsibilities
Quality Master Plan Documentation - Draft and maintain:
Draft and maintain:
Standard Operating Procedures (SOPs)
Work Instructions
Internal « Quality Master Plan » updates
« Project Validation Plan » updates
« Change Control Management » procedure
Project-Specific GMP Documentation
Prepare project-specific quality documentation
FAT, SAT, IQ, and OQ protocols
Support to Project Managers During FAT & SAT Activities
Prepare FAT activities and pre-testing
Support the Project Manager during FAT execution
Follow up on non-conformities
Prepare qualification reports
Additional Responsibilities
Deliver GMP and GDP training and awareness activities
Support the preparation of internal and external audit
Rédaction de documents du « Quality Master Plan » :
Procédure de travail (SOP)
Instruction de travail
Mise à jour du « Quality Master Plan » interne
Mise à jour du « Project Validation Plan »
Procédure de « Change Control Managment»
Rédaction de la documentation GMP spécifique projet:
Rédaction du plan de qualité spécifique à un projet
Réalisation des protocoles FAT/SAT/IQ/OQ
Assistance aux responsables de projets durant les FAT&SAT :
Préparation de la FAT et des tests préliminaires
Accompagnement du responsable de projet durant la FAT
Suivi des non-conformités
Rapport de qualification
Tâches annexes et supplémentaires
Formation et sensibilisation pour GMP et GDP
Préparer les audits internes et externes
Required Experience
Minimum 5 years of experience in GMP documentation, validation, quality assurance, or a regulated pharmaceutical/biotech/medical device environment.
Experience creating and managing GMP documentation (SOPs, protocols, reports, validation plans, quality plans).
Experience supporting FAT, SAT, IQ, and OQ activities.
Experience working within Change Control, Deviation, CAPA, and Document Management systems.
Experience supporting internal and external audits and regulatory inspections.
Skills & Competencies
Strong knowledge of GMP, GDP, and validation requirements.
Excellent technical writing and document control skills.
Ability to review, organize, and maintain complex documentation packages.
Strong attention to detail and compliance mindset.
Effective communication and collaboration with Quality, Engineering, Automation, and Project Management teams.
Strong organizational and prioritization capabilities.
Problem-solving and root cause analysis skills.
Ability to work independently while managing multiple projects and deadlines.
Languages
English: Professional working proficiency (required)
French: fluent (required)
Key Performance Indicators (KPIs)
On-time completion of GMP documentation deliverables.
Percentage of documentation approved without major rework.
Closure rate of documentation review comments.
Timely completion of FAT/SAT/IQ/OQ/PQ documentation packages.
Number of overdue documentation actions.
Audit observations related to documentation compliance.
Change Control documentation closure performance.
Reduction in documentation errors, deviations, or recurring compliance observations.
Audit findings closure rate.
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