CHE - 8262 Baxalta Manufacturing Sarl
Quality Systems Specialist - Documentation(m/w/x)
Vollzeitnur vor OrtBerufserfahren
Neuenburg
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
BRBristol Myers Squibb
.Manager, Quality Operations(m/w/x)
Boudry
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – fortgeschritten
- Deutsch – Grundkenntnisse
Tools & Technologien
- SAP
- Microsoft Office
- OneNote
- Visio
- Quality Management System (QMS)
- Verity
Benefits
Sonstige Vorteile
- Competitive benefits
- Employee resource groups
- Reasonable workplace accommodations
Flexibles Arbeiten
- Work-life balance programs
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Bristol Myers Squibb erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Noch nicht perfekt?
- Takeda
Product Quality Expert(m/w/x)
Vollzeitnur vor OrtBerufserfahrenNeuenburg - Jabil Switzerland Manufacturing GmbH
Facilities / Maintenance Supervisor(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLe Locle - INTEGRA LIFESCIENCES CORP
Quality Compliance Manager - ECMP Site Facilitator(m/w/x)
Vollzeitnur vor OrtSeniorLe Locle, Rietheim-Weilheim - Bristol Myers Squibb
Manager - Site procurement(m/w/x)
Vollzeitnur vor OrtSeniorBoudry
BRBristol Myers Squibb
.Manager, Quality Operations(m/w/x)
Boudry
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – fortgeschritten
- Deutsch – Grundkenntnisse
Tools & Technologien
- SAP
- Microsoft Office
- OneNote
- Visio
- Quality Management System (QMS)
- Verity
Benefits
Sonstige Vorteile
- Competitive benefits
- Employee resource groups
- Reasonable workplace accommodations
Flexibles Arbeiten
- Work-life balance programs
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Bristol Myers Squibb erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
Bristol Myers Squibb
Branche
Pharmaceuticals
Beschreibung
The company is dedicated to transforming patients’ lives through science and promotes global participation in clinical trials.
Noch nicht perfekt?
- CHE - 8262 Baxalta Manufacturing Sarl
Quality Systems Specialist - Documentation(m/w/x)
Vollzeitnur vor OrtBerufserfahrenNeuenburg - Takeda
Product Quality Expert(m/w/x)
Vollzeitnur vor OrtBerufserfahrenNeuenburg - Jabil Switzerland Manufacturing GmbH
Facilities / Maintenance Supervisor(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLe Locle - INTEGRA LIFESCIENCES CORP
Quality Compliance Manager - ECMP Site Facilitator(m/w/x)
Vollzeitnur vor OrtSeniorLe Locle, Rietheim-Weilheim - Bristol Myers Squibb
Manager - Site procurement(m/w/x)
Vollzeitnur vor OrtSeniorBoudry