Becton, Dickinson and Company
Assoc. Director, Quality Management, Contract Manufacturing(m/w/x)
Full-timeOn-siteSenior
Eysins
from CHF 158,600 - 253,775 / year
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20206030 Fresenius Kabi SwissBioSim GmbH
(Senior) Manager – Quality operations and Deputy Responsible Person (RP)(m/w/x)
Eysins
Full-timeOn-siteManagement
Nejo AI Summary
Managing GDP quality tasks and GMP support for medicinal products, fulfilling deputy Responsible Person duties. Significant experience as lead auditor for pharmaceutical manufacturing required. Focus on critical quality assurance and regulatory compliance.
Requirements
- BA/BS, MA/MS in scientific discipline or related field
- 5 years’ experience in Quality function in pharmaceutical industry
- Strong understanding of GMPs, GDP, ICH guidelines
- Significant experience as lead auditor for pharmaceutical manufacturing
- Experience with regulatory agencies such as Swissmedic, EMA, FDA
- Prior experience as deputy Responsible Person & interactions with Swissmedic
- Fluency in English; German and/or French beneficial
- Ability to work effectively in team-oriented environment
- Leadership, Drive, Enthusiasm skills
- Goal-Orientated and commitment to follow up on tasks
- Decision Making, Problem Solving, Independence skills
- Flexibility and willingness to travel (up to approx. 25%)
- Proactive and Self-motivated
Tasks
- Manage GDP-related quality tasks
- Support GMP activities for trading Medicinal Products
- Maintain knowledge of cGxP regulations and applicable standards
- Implement requirements into local procedures
- Act as deputy Responsible Person (RP)
- Support GxP activities for commercial medicinal products
- Contribute to maintenance of Quality Systems for Swissmedic licenses
- Support due diligence and supplier qualification activities
- Manage Quality Agreements and conduct audits
- Oversee collection and processing of Events, Changes, and CAPAs
- Notify management of events requiring immediate action
- Develop and collect Key Quality/Compliance Indicators
- Contribute to continuous improvement of quality processes
- Identify training needs for the BU Pharma & Nutrition team
- Contribute to internal audits and Health Authorities inspections
- Support quality oversight of C(D)MOs and Testing Labs
- Manage Quality Management Reviews for BU Pharma & Nutrition
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Basic
- French – Basic
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 206030 Fresenius Kabi SwissBioSim GmbH 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.
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20206030 Fresenius Kabi SwissBioSim GmbH
(Senior) Manager – Quality operations and Deputy Responsible Person (RP)(m/w/x)
Eysins
Full-timeOn-siteManagement
Nejo AI Summary
Managing GDP quality tasks and GMP support for medicinal products, fulfilling deputy Responsible Person duties. Significant experience as lead auditor for pharmaceutical manufacturing required. Focus on critical quality assurance and regulatory compliance.
Requirements
- BA/BS, MA/MS in scientific discipline or related field
- 5 years’ experience in Quality function in pharmaceutical industry
- Strong understanding of GMPs, GDP, ICH guidelines
- Significant experience as lead auditor for pharmaceutical manufacturing
- Experience with regulatory agencies such as Swissmedic, EMA, FDA
- Prior experience as deputy Responsible Person & interactions with Swissmedic
- Fluency in English; German and/or French beneficial
- Ability to work effectively in team-oriented environment
- Leadership, Drive, Enthusiasm skills
- Goal-Orientated and commitment to follow up on tasks
- Decision Making, Problem Solving, Independence skills
- Flexibility and willingness to travel (up to approx. 25%)
- Proactive and Self-motivated
Tasks
- Manage GDP-related quality tasks
- Support GMP activities for trading Medicinal Products
- Maintain knowledge of cGxP regulations and applicable standards
- Implement requirements into local procedures
- Act as deputy Responsible Person (RP)
- Support GxP activities for commercial medicinal products
- Contribute to maintenance of Quality Systems for Swissmedic licenses
- Support due diligence and supplier qualification activities
- Manage Quality Agreements and conduct audits
- Oversee collection and processing of Events, Changes, and CAPAs
- Notify management of events requiring immediate action
- Develop and collect Key Quality/Compliance Indicators
- Contribute to continuous improvement of quality processes
- Identify training needs for the BU Pharma & Nutrition team
- Contribute to internal audits and Health Authorities inspections
- Support quality oversight of C(D)MOs and Testing Labs
- Manage Quality Management Reviews for BU Pharma & Nutrition
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Basic
- French – Basic
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 206030 Fresenius Kabi SwissBioSim GmbH 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
206030 Fresenius Kabi SwissBioSim GmbH
Industry
Pharmaceuticals
Not a perfect match?
- Becton, Dickinson and Company
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