Manager QA Projects , 100%

more-jobs; Bubendorf; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

Bachem sucht einen erfahrenen Manager QA Projects (a) für 100% Stelle am Standort Basel. Sie leiten QA-bezogene Projekte, treffen Entscheidungen zu QA-Themen und koordinieren Aufgaben mit Produktion, Qualitätskontrolle und Projektmanagement, um GMP-Compliance sicherzustellen.

Sie bringen mindestens 2 Jahre Erfahrung im Projektmanagement und QA in der chemisch-pharmazeutischen Industrie mit, verfügen über solides EU-GMP/FDA-Wissen und beherrschen Risikomanagement.

Qualifikationen

• Master's or Ph.D. in chemistry, biology, pharmacy, or a related field.
• Minimum 2 years in project management and QA within chemical/pharma industries.
• Strong knowledge of EU-GMP and FDA regulations (cGMP).
• Experience supporting process validations including risk management.
• Structured, solution-oriented, and able to communicate complex topics clearly.

Aufgaben

• Represent QA in product-related projects at the site.
• Assess and decide on QA topics within individual projects.
• Coordinate QA tasks and liaise with Production, QC, and PM for cGMP compliance.
• Define control strategies and lifecycle strategies from development to process validation.
• Review and approve GMP documents, changes, deviations, and CAPAs.
• Serve as QA contact for internal and external stakeholders and clients.

Kenntnisse

QA topics knowledge

cGMP knowledge

Process validation experience

Risk management

Ausbildung

Master's or Ph.D. in chemistry, biology, pharmacy, or a comparable technical field

Jobbeschreibung

Manager QA Projects (a), 100%

Bachem ist ein börsenkotiertes, auf die Peptid-Chemie fokussiertes Technologie-Unternehmen mit einem umfassenden Leistungsangebot für die Pharma- und Biotechnologie-Industrie. Bachem ist spezialisiert auf die Entwicklung innovativer, effizienter Herstellungsverfahren und die zuverlässige Produktion Peptid-basierter pharmazeutischer Wirkstoffe. Ein umfangreicher Katalog von Biochemikalien für Forschungszwecke und exklusive Kundensynthesen ergänzen das Angebot. Mit Hauptsitz in der Schweiz sowie Niederlassungen in Europa und den USA ist das Unternehmen weltweit tätig und verfügt über die industrieweit grösste Erfahrung und Fachkompetenz. In der Zusammenarbeit mit ihren Kunden legt Bachem grössten Wert auf Qualität, Innovation und Partnerschaft.

Manager QA Projects (a), 100%

To drive our continuous organic growth, we are constantly looking for highly qualified professionals. To strengthen Quality Assurance team, we are looking for a dedicated and experienced Manager QA Projects (a), 100%.

Your tasks:

• Represent QA in product-related projects at the site.


• Assess and make decisions on QA-relevant topics within individual projects.


• Coordinate project-specific tasks within QA departments and act as a key contact for other departments (e.g., Production, Quality Control, Project Management) regarding cGMP compliance and troubleshooting.


• Define control strategies and overall lifecycle strategies from GMP development through process validation to support commercial manufacturing.


• Review and approve GMP documents, changes, deviation reports, and CAPAs.


• Serve as the contact point for internal and external stakeholders on QA-related matters and represent QA in meetings between Bachem and clients.

Your profile:

• Master's or Ph.D. in chemistry, biology, pharmacy, or a comparable technical field.


• Minimum of 2 years of professional experience in project management and quality assurance within the chemical/pharmaceutical industry.


• Strong understanding of QA topics, solid cGMP knowledge (EU-GMP, FDA), and experience in supporting process validations including risk management.


• Structured and solution-oriented professional with a high level of comprehension and strong communication skills, capable of clearly conveying complex topics internally and externally.


• A quick learner with a resilient, service-minded, and flexible personality who thrives in team environments and makes confident decisions.


• Excellent verbal and written communication skills in both and English.

Our offer:

• A dynamic and rapidly growing work environment with internal development and training opportunities


• Flexible working hours with home office days and an option for obtaining additional vacation days through workload reduction


• Company‑run daycare center on the Bachem Campus in


• 60% coverage of pension fund contributions by Bachem AG as well as option for extra-mandatory pension provision with our Pension Plan Plus


• Access to benefits platforms with discounts from external partners


• Fresh, healthy and varied food in our staff restaurant


• A wide range of free sports activities on the Bachem Campus

Would you like to drive innovation together with us?

Learn more about the Bachem Group and get inspired by our exciting work environment at our location in !