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Pharmaceutical Quality (pQM) Specialist(m/w/x)
Quality oversight for cancer and infectious disease therapies, including CDMO Quality Agreements and batch record review. 3-5 years GMP operations experience required. Equal-Pay certified workplace, inclusive culture.
Requirements
- University degree in Pharmaceutical Sciences, Chemistry, Life Sciences, or related field
- 3-5 years experience in GMP operations (pharmaceutical development, QA/QC, CDMO)
- Solid understanding of EU GMP, ICH guidelines, and quality system elements
- Experience with deviations, CAPA, and batch record review (advantageous)
- Strong analytical and organizational skills
- Ability to work autonomously and within cross-functional teams
- Great ability to build and maintain strong working relationships
- Ability to influence cross-functional stakeholders for quality compliance and project alignment
- Fluent in English
- Fluent in French
Tasks
- Contribute to Quality Agreements with CDMOs
- Represent pQM in assigned development projects
- Manage pharmaceutical quality documentation lifecycle
- Oversee archiving and verification of Batch Record Review files
- Support management of deviations, CAPAs, change controls, and OOS/OOT events
- Ensure inspection readiness with internal teams and CDMOs
- Support quality risk management activities
- Draft SOPs for continuous improvement
- Coordinate GMP training
- Analyze quality KPIs for data-driven decisions
Work Experience
- 3 - 5 years
Education
- Bachelor's degree
Languages
- English – Fluent
- French – Fluent
Benefits
Other Benefits
- Equal-Pay certified workplace
Informal Culture
- Inclusive and respectful workplace
Purpose-Driven Work
- Culture that values people, purpose, and performance
Startup Environment
- Opportunity to grow, share, and shape the future of healthcare
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Pharmaceutical Quality (pQM) Specialist(m/w/x)
Quality oversight for cancer and infectious disease therapies, including CDMO Quality Agreements and batch record review. 3-5 years GMP operations experience required. Equal-Pay certified workplace, inclusive culture.
Requirements
- University degree in Pharmaceutical Sciences, Chemistry, Life Sciences, or related field
- 3-5 years experience in GMP operations (pharmaceutical development, QA/QC, CDMO)
- Solid understanding of EU GMP, ICH guidelines, and quality system elements
- Experience with deviations, CAPA, and batch record review (advantageous)
- Strong analytical and organizational skills
- Ability to work autonomously and within cross-functional teams
- Great ability to build and maintain strong working relationships
- Ability to influence cross-functional stakeholders for quality compliance and project alignment
- Fluent in English
- Fluent in French
Tasks
- Contribute to Quality Agreements with CDMOs
- Represent pQM in assigned development projects
- Manage pharmaceutical quality documentation lifecycle
- Oversee archiving and verification of Batch Record Review files
- Support management of deviations, CAPAs, change controls, and OOS/OOT events
- Ensure inspection readiness with internal teams and CDMOs
- Support quality risk management activities
- Draft SOPs for continuous improvement
- Coordinate GMP training
- Analyze quality KPIs for data-driven decisions
Work Experience
- 3 - 5 years
Education
- Bachelor's degree
Languages
- English – Fluent
- French – Fluent
Benefits
Other Benefits
- Equal-Pay certified workplace
Informal Culture
- Inclusive and respectful workplace
Purpose-Driven Work
- Culture that values people, purpose, and performance
Startup Environment
- Opportunity to grow, share, and shape the future of healthcare
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Debiopharm
Industry
Pharmaceuticals
Description
Debiopharm is a privately-owned Swiss biopharmaceutical company committed to research in oncology and infectious diseases to improve patient outcomes and quality of life.
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