B

Bachem

Develops and manufactures peptides and oligonucleotides

Manager QA - Quality Management Systems, Quality Management Systems

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeBubendorf, SwitzerlandNo salary listed

About the Job

Requirements

  • A completed university degree in natural sciences, pharmacy, or a technical field at Master's level, or at Bachelor's level with relevant professional experience and additional qualifications.
  • Several years of Quality Management experience in a GMP-regulated environment, ideally in the pharmaceutical, biotech, or chemical industry.
  • Good knowledge of GMP and regulatory requirements in Switzerland and the EU.
  • Experience with Quality Management Systems and relevant QMS processes, such as document management, deviations, CAPA, or change management.
  • Experience in process ownership, process management, or subject-matter responsibility for Quality processes.
  • Experience in cross-functional project work and collaboration with different stakeholders.
  • Experience with electronic Quality Management Systems, such as Veeva, MasterControl, or comparable systems.
  • Very good written and spoken German and English.
  • Ability to analyze complex issues in a structured way and develop pragmatic solutions.
  • Strong communication and coordination abilities, and an interest in lateral leadership and cross-functional collaboration.

Responsibilities

  • Own the maintenance, governance, and continuous development of defined QMS processes.
  • Take process-owner or process-lead responsibility for selected Quality processes.
  • Coordinate and support local implementation of global Quality policies, standards, and process requirements.
  • Harmonize, standardize, and continuously improve global QMS processes.
  • Identify compliance risks and improvement opportunities, and initiate and follow up on appropriate actions.
  • Represent local requirements and support implementation of global Quality initiatives.
  • Participate in local and global Quality communities and projects.
  • Collect, analyze, and present relevant QMS metrics and trends.
  • Lead and contribute to projects to harmonize, simplify, and digitize Quality processes.

Desired Qualifications

  • Experience in audit and inspection environments.

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

Recently Posted Jobs

Explore more opportunities at Bachem

See more jobs