About the role

  • Lead CAPA and QA activities in a GMP-regulated environment. Drive continuous improvement of the quality system, training and compliance to protect product quality and patient safety.

Responsibilities

  • In a GMP-regulated environment, ensure compliance with all quality, GMP and regulatory requirements throughout manufacturing, testing and shipping.
  • Manage deviations and CAPA from root cause analysis through SAP-based implementation to effectiveness checks and final evaluation—working together with process owners.
  • Further develop the quality management framework by creating, maintaining and delivering company-wide training on overarching procedures and processes.
  • Increase awareness and compliance within teams through internal trainings on quality-relevant topics.
  • Review manufacturing documentation for GMP compliance, derive corrective actions and track their implementation.
  • Act as a sparring partner for the operational departments by supporting the development of GMP-compliant procedures and promoting stable process flows.
  • Drive QA projects forward and take project leadership when required; confidently represent supported quality processes during inspections.
  • Maintain focus on product impact and patient safety by conducting thorough investigations and producing well-founded risk assessments.

Requirements

  • Completed bachelor’s degree in a natural science, ideally with a focus on quality management
  • Qualification as a quality representative or equivalent professional experience desirable
  • At least 5 years’ professional experience in quality management in the medical device or pharmaceutical sector, or in project management within these industries
  • Solid knowledge of relevant regulatory requirements: GMP, GDP, ISO 13485, FDA Quality System Regulation, MDR
  • Good command of English, both written and spoken
  • Fluent in German, both written and spoken

Benefits

  • Exciting responsibilities — work with a high degree of ownership in an ambitious environment with excellent development opportunities
  • Attractive compensation — competitive base salary according to the chemical industry collective agreement, annual one-off payments (holiday pay, 13th salary, future contribution) and expansion of statutory long-term care insurance with a supplementary care policy
  • Financial additional benefits — support for private retirement provision, a life-phase account for paid leave (e.g., sabbatical, early retirement), discounts in numerous (online) shops, and bicycle leasing
  • Structured working hours — 37.5 hours per week, 1–2 days of remote work per week, time off in lieu for overtime, age-related leave schemes, 30 days annual leave, and special leave for exceptional occasions
  • Health & well-being — occupational health service with comprehensive preventive examinations, social counseling and an on-site employee canteen with freshly prepared meals daily
  • Sustainability and social engagement — sustainability as part of the company strategy and targeted support for initiatives in education, family and science through the company’s own foundations

Job title

Senior Quality Manager, CAPA

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Bachelor's Degree

Tech skills

Location requirements

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