Senior Specialist Quality Assurance (External Manufacturing) m/f/d

  • Berlin
  • Greifswald
  • Remote
  • Vollzeit
Senior Specialist Quality Assurance (External Manufacturing) m/f/d, 1. Bild
We are a global and growing speciality pharmaceutical company with an exceptional, sustainable business model. Our mission: to be THE platform for established and trusted branded products in various therapeutic areas and indications and to ensure their availability in the highest quality as an important partner of the innovation-driven pharmaceutical industry for the global market!

We have a common goal: to improve people's health and lives. That's why we don't think in terms of quick effects, but want to achieve more with our actions - in the long term and reliably.

All of this is only possible with people who don't just do their job, but want to achieve something themselves. We are so successful because we develop and encourage our colleagues and give them the freedom and flexibility they need for their daily work.

Your responsibility:

Quality Oversight & Compliance

  • Provide quality leadership and oversight for products manufactured at external sites.
    Ensure CMOs comply with GMP, global regulatory requirements, and company quality standards
  • Conduct risk assessments, deviation investigations, and approve CAPAs (Corrective & Preventive Actions)
  • Lead or support audits and inspections (regulatory, corporate, and customer)
  • Act as the primary quality interface between the company and assigned CMOs
  • Monitor and evaluate performance of external partners through KPIs and periodic reviews
  • Review and approve technical/quality agreements, manufacturing documents, and change controls
  • Oversee review and approval of batch records, validation reports, and quality documentation
  • Drive quality improvements at external sites to enhance efficiency, compliance, and reliability
  • Identify risks in supply chain and manufacturing processes; develop and implement mitigation strategies
  • Support implementation of Quality Management System (QMS) enhancements across CMOs
  • Partner with Regulatory Affairs, Supply Chain, and other functions for product lifecycle management
  • Provide expert quality input for technology transfers and validation activities
  • Support inspections and responses to authorities

Your Profile:

  • You have successfully completed a degree with a relevant focus (e.g., Pharmacy, Chemistry, Biotechnology, Life Sciences, or similar) or hold a comparable qualified education
  • You have at least 10 years of experience in the pharmaceutical industry, including at least 5 years in Quality Assurance, Quality Compliance, or External Quality. You bring extensive experience in managing external manufacturing organizations (CMOs/CDMOs)
  • You possess solid knowledge of ICH, FDA, EMA, GMP, GDP, and other international regulatory requirements and you also have demonstrable expertise in audits, deviation management, CAPA, and QMS processes, as well as proven success in supporting regulatory inspections (e.g., FDA, EMA)
  • Your communication, negotiation, and stakeholder-management skills are excellent and you work effectively in a matrix and multicultural environment
  • Your work style combines the ability to align compliance requirements with business needs, high attention to detail, and a strong commitment to quality
  • You combine strategic thinking with a hands-on approach
  • You speak fluent English and German at least at level B1 or better.
  • Additionally, you have solid MS Office skills and ideally experience with SAP

Our Offer:

  • A growing company with a diverse and open-minded working environment with employees from around 40 different countries
  • Flexible working models adapted to your needs (e.g. up to 100% remote working and up to two months from abroad within the EU possible), working time account with time off in lieu, 30 days' holiday
  • Flexible benefits budget that you can use according to your individual preferences, such as a higher employer contribution to the company pension scheme, fitness & health offers or subsidies for travel or meal costs. E.g. higher employer contribution to the company pension scheme, fitness & health offers or subsidies for travel or catering costs
  • Discounts at hundreds of partner companies through access to the corporate benefits platform
  • Internal and external training courses, tailored to your personal goals
  • Company and team events to build relationships outside of the workplace and celebrate successes together
  We look forward to receiving your detailed application! Please only use the "Apply now" function for your application.