Quality Assurance Manager (m/f/d)

PXG Pharma GmbH is a well-established, fast-growing healthcare business based in Germany. As one of Europe’s leading providers of premium private label healthcare products and licensed medicines, we offer a broad range of high-performance food supplements, medical devices, cosmetics, medicines, and personal care products. We are active in 25 countries and currently provide over 800 products across a number of premium brands – both our own and the private label brands of our customers.

At PXG Pharma GmbH we are looking for a Quality Assurance Manager (m/f/d) at our headquarters in Mannheim. 

Your Tasks

  • Implement and maintain the quality management systems to ensure compliance with regulations and adherence to PXG Pharma’s quality standards.
  • Support the Head of Quality in managing all aspects of quality assuranceacross our global operations, with a focus on continuous improvement and efficiency.
  • Work closely with various teams to ensure the safety and efficacyof our products, contributing to the overall goal of quality excellence.
  • Foster a culture of quality within their area of responsibility, ensuringthat quality considerations are integral to all decision-making processes
  • Execute supplierqualification processes, includingassessing suppliers againstPXG Pharma’s qualitystandards and maintaining a register of qualified suppliers.
  • Manage relationships with suppliers from a QA perspective, includingconducting regular performance reviews and addressing any quality-related issues promptly.
  • Execute the product qualification process as per Company procedures, ensuring that all products meet the requiredquality standards before they are released to the market.
  • Collaborate with the Product Development and Procurement teams to addressany quality-related issues during the product qualification process.
  • Manage the complaintsprocess, handling any quality-related complaints from customers or regulatory bodies promptly and effectively.
  • Analyze complaint data to identifytrends and areas for improvement in product quality and the quality managementsystem.
  • Organize and document quality relevant processes regardingGMP, GDP, ISO 13485, and Quality Risk Management of PXG Pharma.
  • Enable PXG’s success by ensuring full compliance with legal requirements across all businessareas, including non-licensed products such as vitamins, minerals, food supplements, and medical devices.
  • Continuously improve and support all corresponding processesand facilities ensuring“inspection readiness”.
  • Provide regulatory support and consulting to Business Development and the product managers in the areas of GMP, GDP, medical devices, PPE, food supplements and cosmetics within the scope of business development.
  • Prepare and implementtraining for employeesin accordance with valid regulations and laws.
  • Evaluate the impact of new regulatory requirements in the business processes. Ensure risk-based approaches are used to define or review processes.
  • Ensure maintenance of the Quality network within the business:ensure the share of best practices and relevant information.
  • Deputize the Head of Quality in case of longer absence.

Your Profile

  • Several years of experience in quality management, preferably in the pharmaceutical industry.
  • Experience with quality assurance techniques and tools, and familiarity with industry standards such as GMP, GDP, ISO 13485, IFS and Quality Risk Management.
  • Experience in managing supplier relationships and conducting audits.
  • Excellent communication skills to work effectively with various teams and stakeholders.
  • Ability to perform in a dynamic environment, across different cultures.
  • A bachelor’s degree and master’s degree in Pharmacy, Life Science, Industrial Pharmacy or a related field.
  • It is a plus to fulfil the requirement under § 14 Abs. 1 Nr. 4 of the German Medicines Act (AMG).
  • Fluent in English, very good knowledge of German

Our Benefits:

  • Future-proof: We are growing and expanding. We are the market leader and offer you a permanent employment contract, 13 monthly salaries, vacation pay as well as 30 days of vacation and much more. (job bike, company pension scheme, etc.)
  • Reconciliation of private and professional life: We offer mobile office and flexible working time models.
  • Career: We promote you! There are great opportunities within the PHOENIX Group.
  • Continuing education: We would love to - we are happy if you are eager to learn. The PHOENIX Learning World offers you an exclusive range of further training courses.
  • Team: This is how we work. We promote team cohesion through small and large events.

 

Please apply online including your salary expectation and your earliest possible starting date. Your contact person is Florian Thome. We are looking forward to your application!

 

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