Merck & Co., Inc.
Sr Director Drug Substance Facility Lead(m/w/x)
Full-timeOn-siteManagement
Luzern
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MEMerck & Co., Inc., Rahway, NJ, USA
Responsible Person Dir Quality Assurance(m/w/x)
Werthenstein
Full-timeOn-siteSenior
Nejo AI Summary
Site batch release and certification for biological agents and clinical trial products. Previous Responsible Person experience and Life Science degree required. Support for regulatory inspections (Swissmedic).
Requirements
- Bachelor’s degree in Life Science
- Eligible as Responsible Person per I-SMI.TI.17
- Previous Responsible Person experience
- Strong Quality enterprise systems experience
- Experience supporting regulatory inspections (Swissmedic)
- Cross-functional teamwork, collaboration, influencing, negotiation skills
- Effective communication skills (oral and written)
- Strong project management skills and experience
- Auditing
- Change Management
- Client Relationship Building
- Creativity
- Cross-Cultural Awareness
- Diversity Programs
- Leadership
- Mentoring Staff
- People Leadership
- Pharmacovigilance
- Policy Implementation
- Process Improvements
- Quality Assurance (QA)
- Quality Assurance Systems
- Quality Investigations
- Quality Systems Compliance
- Regulatory Compliance
- Risk Management
Tasks
- Act as Responsible Person for site batch release
- Execute batch record reviews and certification
- Provide Responsible Person input for deviations
- Support batch disposition QMS topics
- Support material review and disposition
- Oversee site internal audit program
- Perform for-cause audits
- Review and approve CAPA responses
- Verify CAPA effectiveness
- Lead audits and mentor site auditors
- Host guest auditors from other sites
- Audit other company sites
- Mentor auditors on compliance skills
- Review and approve audit reports
- Lead initiatives for audits and CAPA
- Manage major change notifications to health authorities
- Approve technical and quality agreements
- Perform risk communication for management
- Provide quality oversight for deviations
- Approve change controls and complaints
- Communicate with functional areas
- Resolve comments and issues during reviews
- Identify compliance gaps
- Implement recommendations for improvement
- Maintain compliance, efficiency, and accuracy
- Stay updated on cGMP requirements
- Represent department on cross-functional teams
- Ensure permanent inspection readiness
- Develop and maintain business processes
- Provide expert technical knowledge
- Perform additional assigned activities
- Provide first-line issue resolution for the team
Work Experience
- 10 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- LIMS
- SAP-Quality
- MES
- Veeva Q-Docs
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Merck & Co., Inc., Rahway, NJ, USA 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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MEMerck & Co., Inc., Rahway, NJ, USA
Responsible Person Dir Quality Assurance(m/w/x)
Werthenstein
Full-timeOn-siteSenior
Nejo AI Summary
Site batch release and certification for biological agents and clinical trial products. Previous Responsible Person experience and Life Science degree required. Support for regulatory inspections (Swissmedic).
Requirements
- Bachelor’s degree in Life Science
- Eligible as Responsible Person per I-SMI.TI.17
- Previous Responsible Person experience
- Strong Quality enterprise systems experience
- Experience supporting regulatory inspections (Swissmedic)
- Cross-functional teamwork, collaboration, influencing, negotiation skills
- Effective communication skills (oral and written)
- Strong project management skills and experience
- Auditing
- Change Management
- Client Relationship Building
- Creativity
- Cross-Cultural Awareness
- Diversity Programs
- Leadership
- Mentoring Staff
- People Leadership
- Pharmacovigilance
- Policy Implementation
- Process Improvements
- Quality Assurance (QA)
- Quality Assurance Systems
- Quality Investigations
- Quality Systems Compliance
- Regulatory Compliance
- Risk Management
Tasks
- Act as Responsible Person for site batch release
- Execute batch record reviews and certification
- Provide Responsible Person input for deviations
- Support batch disposition QMS topics
- Support material review and disposition
- Oversee site internal audit program
- Perform for-cause audits
- Review and approve CAPA responses
- Verify CAPA effectiveness
- Lead audits and mentor site auditors
- Host guest auditors from other sites
- Audit other company sites
- Mentor auditors on compliance skills
- Review and approve audit reports
- Lead initiatives for audits and CAPA
- Manage major change notifications to health authorities
- Approve technical and quality agreements
- Perform risk communication for management
- Provide quality oversight for deviations
- Approve change controls and complaints
- Communicate with functional areas
- Resolve comments and issues during reviews
- Identify compliance gaps
- Implement recommendations for improvement
- Maintain compliance, efficiency, and accuracy
- Stay updated on cGMP requirements
- Represent department on cross-functional teams
- Ensure permanent inspection readiness
- Develop and maintain business processes
- Provide expert technical knowledge
- Perform additional assigned activities
- Provide first-line issue resolution for the team
Work Experience
- 10 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- LIMS
- SAP-Quality
- MES
- Veeva Q-Docs
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Merck & Co., Inc., Rahway, NJ, USA 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
Merck & Co., Inc., Rahway, NJ, USA
Industry
Pharmaceuticals
Description
Merck & Co., Inc. is a global biopharmaceutical company committed to discovering, developing, manufacturing, and marketing a broad range of innovative health care products.
Not a perfect match?
- Merck & Co., Inc.
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Fachverantwortlicher Qualitätsmanagement(m/w/x)
Full-timeOn-siteJuniorHochdorf - 3568 MSD Int. Business GmbH
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