CHE - 8262 Baxalta Manufacturing Sarl
Quality Systems Specialist - Documentation(m/w/x)
Full-timeOn-siteExperienced
Neuenburg
New Job?Nejo!
Your personal AI career agent
BRBristol Myers Squibb
.Manager, Quality Operations(m/w/x)
Boudry
Full-timeOn-siteExperienced
Nejo AI Summary
Quality oversight for CMOs, including disposition documentation and cGMP compliance. Strong technical expertise in deviation resolution and risk assessments required. 4-day work week, company car for private use.
Requirements
- Balance of business, technical, and quality decisions
- Strong negotiation, communication, and presentation skills
- Technical expertise in deviation resolution, CAPA, and risk assessments
- Adaptability to changing environments with flexibility and urgency
- Good verbal, written, and presentation skills in English
- Knowledge of German
- Proficiency with global systems (SAP, Microsoft Office)
- Strong strategic and analytical thinking, problem solving, rapid decision making
- Capability in implementing goals in complex, ambiguous environments
- Negotiating and influencing without authority in complex situations
- Technical writing, computer knowledge, and communication skills
- Minimum B.S. degree in relevant scientific discipline
- Minimum four years experience in pharmaceutical operations
- At least two years in Quality, ideally product release or project quality
- Experience in aseptic, sterile, biological drug product manufacturing
- Experience in contract manufacturing or contract testing
- Experience with technical writing, authoring investigations, risk assessments, process descriptions, or study protocols
- Ability to negotiate and present complex topics verbally and written
- Knowledge of combination products manufacturing or finished drug product packaging
- Experience with biological product testing methods/quality control
- Experience with GMP tools and applications (SAP, QMS, Verity, Microsoft Office)
- Encouragement to apply even if resume doesn't perfectly align
Tasks
- Provide quality oversight for CMOs
- Support CMO disposition documentation management
- Ensure CMO compliance with BMS and cGMP standards
- Perform product disposition activities
- Author and maintain disposition documentation
- Review and recommend disposition of CMO documentation
- Escalate potential issues in disposition
- Maintain and archive batch documentation
- Input deviation, complaint, and change control information
- Prepare and review Quality Agreements
- Manage and report quality metrics
- Prepare Annual Product Quality Reviews
- Ensure inspection and filing submission readiness
- Review analytical and method protocols
- Support commercialization quality activities
- Provide quality support during inspections
- Support supplier relationship and procurement teams
- Review validation documents and change controls
- Escalate compliance gaps to senior management
- Evaluate external quality complaint investigations
- Maintain SAP Master Data for Quality
Work Experience
- 4 years
Education
- Bachelor's degree
Languages
- English – Advanced
- German – Basic
Tools & Technologies
- SAP
- Microsoft Office
- OneNote
- Visio
- Quality Management System (QMS)
- Verity
Benefits
Other Benefits
- Competitive benefits
- Employee resource groups
- Reasonable workplace accommodations
Flexible Working
- Work-life balance programs
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Bristol Myers Squibb 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.
Not a perfect match?
- Takeda
Product Quality Expert(m/w/x)
Full-timeOn-siteExperiencedNeuenburg - INTEGRA LIFESCIENCES CORP
Quality Compliance Manager - ECMP Site Facilitator(m/w/x)
Full-timeOn-siteSeniorLe Locle, Rietheim-Weilheim - Bristol Myers Squibb
Manager - Site procurement(m/w/x)
Full-timeOn-siteSeniorBoudry - CHE - 8262 Baxalta Manufacturing Sarl
Senior Operational Excellence Champion - Lean Black Belt(m/w/x)
Full-timeOn-siteSeniorNeuenburg
BRBristol Myers Squibb
.Manager, Quality Operations(m/w/x)
Boudry
Full-timeOn-siteExperienced
Nejo AI Summary
Quality oversight for CMOs, including disposition documentation and cGMP compliance. Strong technical expertise in deviation resolution and risk assessments required. 4-day work week, company car for private use.
Requirements
- Balance of business, technical, and quality decisions
- Strong negotiation, communication, and presentation skills
- Technical expertise in deviation resolution, CAPA, and risk assessments
- Adaptability to changing environments with flexibility and urgency
- Good verbal, written, and presentation skills in English
- Knowledge of German
- Proficiency with global systems (SAP, Microsoft Office)
- Strong strategic and analytical thinking, problem solving, rapid decision making
- Capability in implementing goals in complex, ambiguous environments
- Negotiating and influencing without authority in complex situations
- Technical writing, computer knowledge, and communication skills
- Minimum B.S. degree in relevant scientific discipline
- Minimum four years experience in pharmaceutical operations
- At least two years in Quality, ideally product release or project quality
- Experience in aseptic, sterile, biological drug product manufacturing
- Experience in contract manufacturing or contract testing
- Experience with technical writing, authoring investigations, risk assessments, process descriptions, or study protocols
- Ability to negotiate and present complex topics verbally and written
- Knowledge of combination products manufacturing or finished drug product packaging
- Experience with biological product testing methods/quality control
- Experience with GMP tools and applications (SAP, QMS, Verity, Microsoft Office)
- Encouragement to apply even if resume doesn't perfectly align
Tasks
- Provide quality oversight for CMOs
- Support CMO disposition documentation management
- Ensure CMO compliance with BMS and cGMP standards
- Perform product disposition activities
- Author and maintain disposition documentation
- Review and recommend disposition of CMO documentation
- Escalate potential issues in disposition
- Maintain and archive batch documentation
- Input deviation, complaint, and change control information
- Prepare and review Quality Agreements
- Manage and report quality metrics
- Prepare Annual Product Quality Reviews
- Ensure inspection and filing submission readiness
- Review analytical and method protocols
- Support commercialization quality activities
- Provide quality support during inspections
- Support supplier relationship and procurement teams
- Review validation documents and change controls
- Escalate compliance gaps to senior management
- Evaluate external quality complaint investigations
- Maintain SAP Master Data for Quality
Work Experience
- 4 years
Education
- Bachelor's degree
Languages
- English – Advanced
- German – Basic
Tools & Technologies
- SAP
- Microsoft Office
- OneNote
- Visio
- Quality Management System (QMS)
- Verity
Benefits
Other Benefits
- Competitive benefits
- Employee resource groups
- Reasonable workplace accommodations
Flexible Working
- Work-life balance programs
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Bristol Myers Squibb 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
Bristol Myers Squibb
Industry
Pharmaceuticals
Description
The company is dedicated to transforming patients’ lives through science and promotes global participation in clinical trials.
Not a perfect match?
- CHE - 8262 Baxalta Manufacturing Sarl
Quality Systems Specialist - Documentation(m/w/x)
Full-timeOn-siteExperiencedNeuenburg - Takeda
Product Quality Expert(m/w/x)
Full-timeOn-siteExperiencedNeuenburg - INTEGRA LIFESCIENCES CORP
Quality Compliance Manager - ECMP Site Facilitator(m/w/x)
Full-timeOn-siteSeniorLe Locle, Rietheim-Weilheim - Bristol Myers Squibb
Manager - Site procurement(m/w/x)
Full-timeOn-siteSeniorBoudry - CHE - 8262 Baxalta Manufacturing Sarl
Senior Operational Excellence Champion - Lean Black Belt(m/w/x)
Full-timeOn-siteSeniorNeuenburg