Inactive

Bachem

Develops and manufactures peptides and oligonucleotides

Manager QA Projects

Regulatory & Quality (Life Sciences)Posted on Nov 13

Full-timeBubendorf, SwitzerlandNo salary listed

About the Job

Requirements

A Master's or Ph.D. in chemistry, biology, pharmacy, or a comparable technical field is required.
At least 2 years of professional experience in project management and quality assurance within the chemical or pharmaceutical industry is required.
A strong understanding of quality assurance topics and solid current Good Manufacturing Practice knowledge, including EU-GMP and FDA requirements, is required.
Experience supporting process validations, including risk management, is required.
Excellent verbal and written communication skills in both German and English are required.

Responsibilities

Represent Quality Assurance in product-related projects at the Bubendorf site.
Assess and make decisions on Quality Assurance-relevant topics within individual projects.
Coordinate project-specific tasks within Quality Assurance departments and act as a key contact for other departments, including Production, Quality Control, and Project Management, regarding current Good Manufacturing Practice compliance and troubleshooting.
Define control strategies and overall lifecycle strategies from Good Manufacturing Practice development through process validation to support commercial manufacturing.
Review and approve Good Manufacturing Practice documents, changes, deviation reports, and corrective and preventive actions.
Serve as the contact point for internal and external stakeholders on Quality Assurance matters and represent Quality Assurance in meetings between Bachem and clients.

Desired Qualifications

A structured and solution-oriented approach, high comprehension, and the ability to clearly convey complex topics internally and externally.
A quick-learning, resilient, service-minded, and flexible approach, with confidence in decision-making and the ability to thrive in a team environment.

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 Bubendorf 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 German 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 Bubendorf
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?

We look forward to receiving your complete application documents via our application portal.

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

About the Company

Bachem

Develops and manufactures peptides and oligonucleotides

Bachem provides development and manufacturing of peptides and oligonucleotides for research, clinical development, and commercial products. Its offerings include custom synthesis and scale-up production, analytical testing, and related services across the drug development spectrum. Customers work with Bachem by specifying desired sequences and specifications, after which Bachem designs, synthesizes, and quality-controls the peptides or oligonucleotides and delivers them in appropriate scales and formats. The company differentiates itself through more than five decades of experience, a global footprint with sites in Europe, the US, and Asia, and an integrated set of services spanning discovery support to commercial manufacturing. Its goal is to help pharmaceutical and biotechnology companies advance peptide- and oligonucleotide-based therapies by providing reliable, scalable, and well-supported manufacturing and development capabilities.

Company size: 1,001-5,000
Company stage: IPO
Headquarters: Bubendorf, Switzerland
Founded: 1971

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