Merck & Co., Inc., Rahway, NJ, USA
Responsible Person Dir Quality Assurance(m/w/x)
Full-timeOn-siteSenior
Werthenstein
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MEMerck & Co., Inc., Rahway, NJ, USA
Associate Director Quality Assurance(m/w/x)
Luzern
Full-timeOn-siteSenior
Nejo AI Summary
Ensuring GMP compliance for clinical supply functions at Werthenstein site, including leading Health Authority Inspections. In-depth knowledge of integrated, automated operations and drug substance manufacturing experience required. Forensic laboratory operations in Schachen, focusing on oncology and infectious diseases.
Requirements
- In-depth knowledge of integrated, automated, recipe-driven operations (e.g., DeltaV, SAP, MES)
- Experience in drug substance manufacturing
- Participation and leading Health Authority Inspections
- Experience in pharmaceutical, biotech, or regulated industry
- Technical writing (investigations, lab reports, SOPs, batch records, protocols)
- Ability to conduct multiple investigations within deadlines
- Ability to manage multiple projects and initiatives
- Master’s Degree in Engineering, Sciences, or related field
- Experience with formal problem-solving techniques (e.g., RCA, Lean Six Sigma)
- cGMP experience in sterile, vaccine, bulk, or finished goods pharma environment
- Detailed understanding of CPPs, CQAs, and equipment qualification principles
- Adaptability
- Audit Management
- Compliance Investigations
- Compliance Programs
- Computer System Validation (CSV)
- Deviation Management
- Global Program Development
- GMP Compliance
- Good Manufacturing Practices (GMP)
- Project Leadership
- Project Risk Assessments
- Quality Assurance Systems
- Quality Management System Improvement
- Quality Oversight
- Quality Risk Management
- Quality Standards
- Quality Systems Compliance
- Regulatory Compliance
- Risk Management and Mitigation
- Risk Mitigation Strategies
- SAP PP (Production Planning)
- Strategic Thinking
- Systematic Problem Solving
- Technical Writing
- Training and Development
Tasks
- Report to Associate Director, QA Operation Schachen Biologics
- Support clinical quality activities at Werthenstein site
- Ensure GMP compliance for clinical supply functions
- Lead and support compliance-based programs and projects
- Solve complex quality and compliance problems
- Initiate and manage quality system improvements
- Develop and implement quality directives
- Monitor and report compliance metrics
- Manage and update Standard Operating Procedures (SOPs)
- Assess and report compliance status and risk posture
- Stay informed of current GMP requirements and industry trends
- Comment on proposed regulations and communicate impacts
- Ensure departmental SOPs align with current regulations
- Review and approve GMP documentation for regulatory filings
- Prepare for and accompany regulatory agency inspections
- Draft responses to inspectional observations
- Advise on GMP compliance for facility design and equipment selection
- Represent Quality in internal and external manufacturing programs
- Review and approve batch records and deviations
- Manage activities within resource constraints
- Develop quality systems and policies for Development Quality
- Represent Development Quality on project teams
- Participate in GMP audit and inspection programs
- Evaluate and report audit findings
- Notify management of compliance issues and trends
- Lead implementation of automated IT systems for efficiency projects
- Contribute to QMS redesign for facility and lab
- Participate in due diligence for new asset integration
- Review external vendor documents for risk mitigation
- Upskill less experienced staff to manage complex tasks
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Fluent
- German – Advanced
Tools & Technologies
- DeltaV
- SAP
- Manufacturing Execution System
- Root Cause Analysis
- Lean Six Sigma
- SAP PP (Production Planning)
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
Associate Director Quality Assurance(m/w/x)
Luzern
Full-timeOn-siteSenior
Nejo AI Summary
Ensuring GMP compliance for clinical supply functions at Werthenstein site, including leading Health Authority Inspections. In-depth knowledge of integrated, automated operations and drug substance manufacturing experience required. Forensic laboratory operations in Schachen, focusing on oncology and infectious diseases.
Requirements
- In-depth knowledge of integrated, automated, recipe-driven operations (e.g., DeltaV, SAP, MES)
- Experience in drug substance manufacturing
- Participation and leading Health Authority Inspections
- Experience in pharmaceutical, biotech, or regulated industry
- Technical writing (investigations, lab reports, SOPs, batch records, protocols)
- Ability to conduct multiple investigations within deadlines
- Ability to manage multiple projects and initiatives
- Master’s Degree in Engineering, Sciences, or related field
- Experience with formal problem-solving techniques (e.g., RCA, Lean Six Sigma)
- cGMP experience in sterile, vaccine, bulk, or finished goods pharma environment
- Detailed understanding of CPPs, CQAs, and equipment qualification principles
- Adaptability
- Audit Management
- Compliance Investigations
- Compliance Programs
- Computer System Validation (CSV)
- Deviation Management
- Global Program Development
- GMP Compliance
- Good Manufacturing Practices (GMP)
- Project Leadership
- Project Risk Assessments
- Quality Assurance Systems
- Quality Management System Improvement
- Quality Oversight
- Quality Risk Management
- Quality Standards
- Quality Systems Compliance
- Regulatory Compliance
- Risk Management and Mitigation
- Risk Mitigation Strategies
- SAP PP (Production Planning)
- Strategic Thinking
- Systematic Problem Solving
- Technical Writing
- Training and Development
Tasks
- Report to Associate Director, QA Operation Schachen Biologics
- Support clinical quality activities at Werthenstein site
- Ensure GMP compliance for clinical supply functions
- Lead and support compliance-based programs and projects
- Solve complex quality and compliance problems
- Initiate and manage quality system improvements
- Develop and implement quality directives
- Monitor and report compliance metrics
- Manage and update Standard Operating Procedures (SOPs)
- Assess and report compliance status and risk posture
- Stay informed of current GMP requirements and industry trends
- Comment on proposed regulations and communicate impacts
- Ensure departmental SOPs align with current regulations
- Review and approve GMP documentation for regulatory filings
- Prepare for and accompany regulatory agency inspections
- Draft responses to inspectional observations
- Advise on GMP compliance for facility design and equipment selection
- Represent Quality in internal and external manufacturing programs
- Review and approve batch records and deviations
- Manage activities within resource constraints
- Develop quality systems and policies for Development Quality
- Represent Development Quality on project teams
- Participate in GMP audit and inspection programs
- Evaluate and report audit findings
- Notify management of compliance issues and trends
- Lead implementation of automated IT systems for efficiency projects
- Contribute to QMS redesign for facility and lab
- Participate in due diligence for new asset integration
- Review external vendor documents for risk mitigation
- Upskill less experienced staff to manage complex tasks
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Fluent
- German – Advanced
Tools & Technologies
- DeltaV
- SAP
- Manufacturing Execution System
- Root Cause Analysis
- Lean Six Sigma
- SAP PP (Production Planning)
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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
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., Rahway, NJ, USA
Responsible Person Dir Quality Assurance(m/w/x)
Full-timeOn-siteSeniorWerthenstein - Merck & Co., Inc.
Sr Director Drug Substance Facility Lead(m/w/x)
Full-timeOn-siteManagementLuzern - AbbVie
QA Manager (FvP/Responsible Person)(m/w/x)
Full-timeOn-siteSeniorCham - Sanofi International AG
Global Head of Strategic Projects and Portfolio Management EM&S – Global Launch Center(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz - Roche Diagnostics Int. AG
Senior Engineer - Design Control Excellence(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz