Debiopharm
Pharmaceutical
PharmaceuticalQuality(pQM)Specialist
“Pharmaceutical Quality (pQM) Specialist at Debiopharm. Skills: Pharmaceutical Quality System (PQS) strengthening, GMP support to development projects and external manufacturing partners, External Partnership Management, Project Representation, Quality Documentation Management, System Operations support, Compliance & Inspection support, Continuous Improvement initiatives. Ensure robust oversight of quality documentation and vendor activities. Strengthen the Pharmaceutical Quality System (PQS)”
What You'll Achieve.
Improve the lives of people affected by cancer and infectious diseases; Transform promising therapies into treatments that can reach those who need them most, faster; Support the high-quality development of investigational medicinal products for our patients; Ensure inspection readiness; Enable data-driven decision-making
Industry & Context.
analytical skills
What They're Looking For.
Must Have
University degree in Pharmaceutical Sciences, Chemistry, Life Sciences, or a related field, Proven experience from at least 3-5 years in GMP operations within pharmaceutical development, QA/QC, or CDMO environments, A solid understanding of EU GMP, ICH guidelines, and quality system elements, analytical and organizational skills with the ability to work both autonomously and within cross-functional teams, Great ability to build and maintain working relationships across departments, and to influence cross-functional stakeholders to ensure quality compliance and project alignment, Fluent in both English and in French
Nice to Have
Experience with deviations, CAPA, and batch record review is considered a advantage
What You'll Do.
Ensure robust oversight of quality documentation and vendor activities
Strengthen the Pharmaceutical Quality System (PQS)
Contribute to the preparation
and implementation of Quality Agreements with CDMOs
Act as the pQM representative for assigned development projects
offering GMP guidance throughout the product lifecycle
Manage the lifecycle of pharmaceutical quality documentation
Oversee the archiving and verification of Batch Record Review files
Support Quality Leads in managing deviations
Collaborate with internal teams and CDMOs to ensure inspection readiness
Support quality risk management activities
Coordinate GMP training
Analyze quality KPIs to enable data-driven decision-making
How You'll Work.
Team & Collaboration
Work within cross-functional teams; Build and maintain working relationships across departments; Influence cross-functional stakeholders to ensure quality compliance and project alignment; Collaborate with internal teams and CDMOs
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