Idorsia Pharmaceuticals Ltd
Senior Clinical QA Manager(m/w/x)
Full-timeOn-siteSenior
Basel
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IDIdorsia Pharmaceuticals Ltd
Global Senior Pharmacovigilance QA Manager(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
Leading compliance audit programs and standardizing drug safety approaches across affiliate sites for a biopharmaceutical company. Master's degree in a scientific discipline and expert pharmacovigilance regulations knowledge required. Global scope with cross-affiliate coordination.
Requirements
- Experience in Commercial GDP QA/Supply Chain QA
- Strong background in Pharmacovigilance/Drug Safety and master's degree in relevant scientific discipline
- Expert knowledge of international Pharmacovigilance regulations
- In-depth knowledge of pharmaceutical industry practices
- Experience in training employees on GVP requirements
- At least 10 years of QA/industry/health authority experience
- Prior experience in coordination of Pharmacovigilance inspections
- Reliability, conscientiousness, and goal orientation
- Excellent problem-solving and risk management skills
- Ability to work independently and in a team
- Excellent communication and interpersonal skills
- Ability to establish collaborative partnerships and apply diplomatic skills
- Fluency in English; knowledge of German and French advantageous
- Experience in GDP, warehousing, and distribution of commercial products
- Proficiency in Microsoft Office applications
Tasks
- Lead and manage PV compliance audit programs
- Ensure standardized PV approach across affiliate sites
- Establish and maintain relationships with internal stakeholders
- Provide expert-level PV knowledge and guidance
- Lead key project initiatives across the organization
- Offer strategic advice to stakeholders for policy decisions
- Act as local PV QA Manager for affiliate sites
- Support affiliates in implementing local PV systems
- Maintain and improve a global PV QA audit program
- Perform PV QA audits of vendors and affiliates
- Track, record, and report audit results consistently
- Identify and document corrective/preventive actions
- Cooperate with EU QPPV and national Affiliate Safety Managers
- Prepare for and follow up on inspections at Idorsia sites
- Escalate significant PV compliance issues to senior management
- Provide QA output to establish and maintain PSMF Quality section
- Ensure inspection readiness of vendors conducting PV activities
- Review archiving procedures at affiliate sites
- Evaluate CAPA and deviation management procedures
- Manage non-conformances related to GxP
- Collaborate with HQ QA on documentation and training records
- Plan periodic information exchanges on PV system topics
- Stay updated on global pharmacovigilance regulations
- Inform management about changes in country-specific PV laws
- Review key global and local Quality System documents
- Drive accountability for Quality and Compliance
Work Experience
- 10 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Basic
- French – Basic
Tools & Technologies
- Microsoft Office
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Idorsia Pharmaceuticals Ltd and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Not a perfect match?
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IDIdorsia Pharmaceuticals Ltd
Global Senior Pharmacovigilance QA Manager(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
Leading compliance audit programs and standardizing drug safety approaches across affiliate sites for a biopharmaceutical company. Master's degree in a scientific discipline and expert pharmacovigilance regulations knowledge required. Global scope with cross-affiliate coordination.
Requirements
- Experience in Commercial GDP QA/Supply Chain QA
- Strong background in Pharmacovigilance/Drug Safety and master's degree in relevant scientific discipline
- Expert knowledge of international Pharmacovigilance regulations
- In-depth knowledge of pharmaceutical industry practices
- Experience in training employees on GVP requirements
- At least 10 years of QA/industry/health authority experience
- Prior experience in coordination of Pharmacovigilance inspections
- Reliability, conscientiousness, and goal orientation
- Excellent problem-solving and risk management skills
- Ability to work independently and in a team
- Excellent communication and interpersonal skills
- Ability to establish collaborative partnerships and apply diplomatic skills
- Fluency in English; knowledge of German and French advantageous
- Experience in GDP, warehousing, and distribution of commercial products
- Proficiency in Microsoft Office applications
Tasks
- Lead and manage PV compliance audit programs
- Ensure standardized PV approach across affiliate sites
- Establish and maintain relationships with internal stakeholders
- Provide expert-level PV knowledge and guidance
- Lead key project initiatives across the organization
- Offer strategic advice to stakeholders for policy decisions
- Act as local PV QA Manager for affiliate sites
- Support affiliates in implementing local PV systems
- Maintain and improve a global PV QA audit program
- Perform PV QA audits of vendors and affiliates
- Track, record, and report audit results consistently
- Identify and document corrective/preventive actions
- Cooperate with EU QPPV and national Affiliate Safety Managers
- Prepare for and follow up on inspections at Idorsia sites
- Escalate significant PV compliance issues to senior management
- Provide QA output to establish and maintain PSMF Quality section
- Ensure inspection readiness of vendors conducting PV activities
- Review archiving procedures at affiliate sites
- Evaluate CAPA and deviation management procedures
- Manage non-conformances related to GxP
- Collaborate with HQ QA on documentation and training records
- Plan periodic information exchanges on PV system topics
- Stay updated on global pharmacovigilance regulations
- Inform management about changes in country-specific PV laws
- Review key global and local Quality System documents
- Drive accountability for Quality and Compliance
Work Experience
- 10 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Basic
- French – Basic
Tools & Technologies
- Microsoft Office
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Idorsia Pharmaceuticals Ltd and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Idorsia Pharmaceuticals Ltd
Industry
Pharmaceuticals
Description
Idorsia is a biopharmaceutical company focused on discovering, developing, and commercializing transformative medicines.
Not a perfect match?
- Idorsia Pharmaceuticals Ltd
Senior Clinical QA Manager(m/w/x)
Full-timeOn-siteSeniorBasel - 1201 F. Hoffmann-La Roche AG
QA Manager(m/w/x)
Full-timeOn-siteSeniorKaiseraugst - Idorsia Pharmaceuticals Ltd
Drug Safety Scientist(m/w/x)
Full-timeOn-siteSeniorAllschwil - Roche
Senior Vice President - Global Head of Safety Risk Management(m/w/x)
Full-timeOn-siteManagementBasel - 1201 F. Hoffmann-La Roche AG
QA Manager IT/OT(m/w/x)
Full-timeOn-siteSeniorBasel