Senior Quality Assurance Manager* (m/w/d) / Senior Manager Qualitätssicherung / Non-Profit-Pharmaunternehmen

Welcome to DIZG!

We -- the German Institute for Cell and Tissue Replacement -- are a non-profit drug manufacturer from Berlin and have been one of the largest pharmaceutical and biotechnologically oriented non-profit institutions of its kind in Europe for 30 years. We are dedicated to promoting healthcare through innovative solutions. As specialists in human transplants, we strive for the highest quality to contribute to the health and well-being of patients worldwide.

Our constantly growing team of 140 dedicated employees, whether in manufacturing, accounting, research & development, marketing, sales, or legal, works daily to supply clinics and surgeons in Germany and Europe with human cell and tissue transplants for surgical procedures, including in trauma surgery, orthopedics, and reconstructive surgery.

We are looking for you, starting immediately, full-time, as Senior Quality Assurance Manager (m/f/d) / Senior Manager Quality Assurance*.

What you do with us

You are primarily responsible for:

• Defining qualification and validation measures and supporting qualification and validation processes, taking regulatory requirements into account
• Supplier and service provider management
• Creating risk analyses (e.g., processes, CCS) in collaboration with the departments

In addition, you will support the following tasks:

• Evaluation of deviations / OOS, root cause and extent analysis, and definition of measures for CAPA plans, including their implementation
• Support and monitoring of change control procedures
• Identification and implementation of improvement potentials (processes and quality systems)
• Training and support regarding systems, policies, procedures, and core processes related to quality assurance
• Creation and adaptation of existing quality assurance procedures and work instructions
• Preparation and execution of customer and supplier audits, including processing deviations

What you bring with you

• A completed technical or scientific degree, e.g., in pharmacy, chemistry, biology, biotechnology, engineering, or a comparable qualification
• At least 8 years of professional experience in quality assurance, ideally in a manufacturing pharmaceutical company
• A very good understanding of relevant regulations (e.g., EU-GMP, ICH, EDQM)
• Deviation management, CAPA, change control, qualification/validation, risk analyses, and audit/supplier management are routine for you
• Proficiency in common quality management systems (e.g., eQMS, DMS, SOP and Form Guard) and MS 365; experience with digital GxP systems is an advantage
• Very good German and good English skills, both written and spoken

What we offer you

• A permanent employment contract in a secure industry
• Annual special payment (depending on economic success)
• Recreation allowance (depending on economic success)
• An annual automatic salary increase (depending on economic success)
• 30 days of vacation with a 5-day work week
• 3 paid leave days per year
• Flexible working hours between 5 AM and 10 PM
• Up to 2 days of home office per week
• Structured onboarding
• Responsibility and creative freedom
• Flat hierarchies and real teamwork
• Company covers the cost of your work glasses
• 20% employer contribution to your company pension plan
• €29 employer contribution to the BVG ticket (environmental ticket or Deutschlandticket) or alternatively a €29 monthly subsidy for charging e-vehicles on our company premises
• Access to the corporate benefits discount platform
• Free fruit and drinks
• Rolls and salads for a small fee
• Free parking
• €60 Amazon birthday voucher
• Team events and company celebrations
• And above all, a truly meaningful activity, on whose success the health recovery of seriously ill people or even their survival depends. With us, you are part of a smart, diverse team characterized by commitment and helpfulness, which wants to achieve a lot with you.

Do you have any questions?

You can reach us by phone at 030 / 6576 - 4080. We look forward to your application! You can find more about us and our work on our website at www.dizg.de. Also, follow us on LinkedIn to stay up-to-date.

We do not tolerate any form of discrimination, whether based on ethnic origin, age, religion, belief, gender, sexual identity, marital status, disability, or any other characteristic.

We store and process your personal data (including your application documents) for the purpose of the application procedure. Our data protection notices apply.