Die KI-Suchmaschine für Jobs
Specialist QA Compliance(m/w/x)
Beschreibung
You will strengthen the global quality footprint by managing MAH compliance processes, advising partners on GMP matters, and fostering a culture of excellence through training.
Lass KI die perfekten Jobs für dich finden!
Lade deinen CV hoch und die Nejo-KI findet passende Stellenangebote für dich.
Anforderungen
- •Degree in Life Sciences, Pharmacy, Chemistry, or related field
- •Advanced degrees or certifications in Quality Management or Regulatory Affairs (plus)
- •3+ years experience in GMP Compliance, QMS, and MAH/Sponsor processes
- •Strong analytical and problem-solving skills
- •Ability to interpret complex regulatory requirements
- •Ability to work collaboratively in matrix organizations
- •Relationship and network building skills
- •Proactive approach to risk identification
- •Drive for continuous improvement initiatives
- •Excellent written and verbal English communication skills
- •Ability to deliver training and present information
Ausbildung
Berufserfahrung
3 Jahre
Aufgaben
- •Design and maintain the MAH/Sponsor process landscape
- •Ensure global regulatory compliance for manufacturing processes
- •Advise strategic partners on complex GMP matters
- •Prepare recommendations for compliance decision-making
- •Coordinate and support Quality forums and committees
- •Deliver compliance training to various stakeholders
- •Promote a quality-driven mindset across the organization
- •Support peers within the Quality matrix organization
- •Collaborate with teams to resolve compliance problems
- •Improve the pharmaceutical quality system per ICH guidelines
- •Report on quality metrics and identify risks
- •Implement mitigation strategies for operational excellence
Tools & Technologien
Sprachen
Englisch – verhandlungssicher
Benefits
Flexibles Arbeiten
- •Flexible hours
Mehr Urlaubstage
- •Vacation account
Weiterbildungsangebote
- •Digital Learning
- •LinkedIn Learning
Karriere- und Weiterentwicklung
- •Performance and talent development
- •Leadership development
Sonstige Vorteile
- •Apprenticeships
Lockere Unternehmenskultur
- •Culture on an equal footing
Sinnstiftende Arbeit
- •Opportunities to shape and impact
Mentoring & Coaching
- •Support for your full potential
Firmenfahrrad
- •Company bike
Öffi Tickets
- •Job ticket
- •Deutschlandticket
Betriebliche Altersvorsorge
- •Employer-funded pension
Kinderbetreuung
- •Childcare
- BioNTech SEVollzeitnur vor OrtSeniorMainz
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Specialist QA Compliance(m/w/x)
Die KI-Suchmaschine für Jobs
Beschreibung
You will strengthen the global quality footprint by managing MAH compliance processes, advising partners on GMP matters, and fostering a culture of excellence through training.
Lass KI die perfekten Jobs für dich finden!
Lade deinen CV hoch und die Nejo-KI findet passende Stellenangebote für dich.
Anforderungen
- •Degree in Life Sciences, Pharmacy, Chemistry, or related field
- •Advanced degrees or certifications in Quality Management or Regulatory Affairs (plus)
- •3+ years experience in GMP Compliance, QMS, and MAH/Sponsor processes
- •Strong analytical and problem-solving skills
- •Ability to interpret complex regulatory requirements
- •Ability to work collaboratively in matrix organizations
- •Relationship and network building skills
- •Proactive approach to risk identification
- •Drive for continuous improvement initiatives
- •Excellent written and verbal English communication skills
- •Ability to deliver training and present information
Ausbildung
Berufserfahrung
3 Jahre
Aufgaben
- •Design and maintain the MAH/Sponsor process landscape
- •Ensure global regulatory compliance for manufacturing processes
- •Advise strategic partners on complex GMP matters
- •Prepare recommendations for compliance decision-making
- •Coordinate and support Quality forums and committees
- •Deliver compliance training to various stakeholders
- •Promote a quality-driven mindset across the organization
- •Support peers within the Quality matrix organization
- •Collaborate with teams to resolve compliance problems
- •Improve the pharmaceutical quality system per ICH guidelines
- •Report on quality metrics and identify risks
- •Implement mitigation strategies for operational excellence
Tools & Technologien
Sprachen
Englisch – verhandlungssicher
Benefits
Flexibles Arbeiten
- •Flexible hours
Mehr Urlaubstage
- •Vacation account
Weiterbildungsangebote
- •Digital Learning
- •LinkedIn Learning
Karriere- und Weiterentwicklung
- •Performance and talent development
- •Leadership development
Sonstige Vorteile
- •Apprenticeships
Lockere Unternehmenskultur
- •Culture on an equal footing
Sinnstiftende Arbeit
- •Opportunities to shape and impact
Mentoring & Coaching
- •Support for your full potential
Firmenfahrrad
- •Company bike
Öffi Tickets
- •Job ticket
- •Deutschlandticket
Betriebliche Altersvorsorge
- •Employer-funded pension
Kinderbetreuung
- •Childcare
Über das Unternehmen
BioNTech SE
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen entwickelt bahnbrechende Medikamente zur Verbesserung der globalen Gesundheit und zur Bekämpfung von Krankheiten.
- BioNTech SE
Manager QA Compliance(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Engineer Compliance & Qualification GMP(m/w/x)
Vollzeitnur vor OrtBerufserfahrenMainz - BioNTech SE
Engineer Compliance CSV & DI(m/w/x)
Vollzeitnur vor OrtBerufserfahrenMainz - BioNTech SE
Associate Director SCM Compliance(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Manager Compliance Engineering(m/w/x)
Vollzeitnur vor OrtBerufserfahrenMainz