Head of External Manufacturing & Partnering Quality Assurance
Duchnice (pow. warszawski zachodni)

Boost your career with us

Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.

Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!

Your role

In this role you will be responsible for all aspects of Quality Assurance with respect to supply of products to Polpharma Biologics from external suppliers (API, Drug Products and Finished Products) and to Third-Party QC Laboratory Services. You will be also responsible for ensuring appropriate oversight, assessment and mitigation of risk related to quality practices and supply, and for ensuring that all aspects of the relationship, and the management thereof, are in compliance with cGMP and regulatory requirements, Polpharma Biologics Group procedures and industry practices. You will be tasked with responsibility for the Quality liaison with customers where Polpharma Biologics Group provides CDMO services.

Your responsibilities

  • Management, support and supervising Third Parties and Licensees with respect to implementation and maintenance of local Quality Management Systems and with regards to provision of adequate resources and performance monitoring
  • Ensuring the Quality Assurance Agreements are created and maintained according to Polpharma Biologics requirements, that they are regularly reviewed and followed, and that they address the respective roles, responsibilities and requirements for all parties involved in the supply of the product
  • Ensuring that all aspects of Quality Management of the External Manufacturer are carried out according to the standards defined, and are regularly reported and assessed for adequacy of performance
  • Determining the quality strategy and the Quality Planning for the External Manufacturing of Polpharma Biologics and ensuring that all critical issues are incorporated with clear and timely actions to address the issues
  • Implementing and maintaining a Quality Risk Management program that assesses the individual Quality Risk Assessments of Third Parties and the adequacy of proposed CAPA plans
  • Mitigating unacceptable risk in conjunction with External Supply management and Polpharma Biologics Quality
  • Ensuring robust review and escalation of critical quality issues arising within the area of responsibility
  • Management and approving all major and critical quality issues according to the Quality Agreement and Polpharma Biologics procedures, as well as ensuring that investigations are correctly executed, and all required actions are taken appropriately and in a timely fashion
  • Management and approving major changes according to the Quality Agreement and Polpharma Biologics procedures, as well as ensuring that assessments are correctly executed, liaise with technical and regulatory functions, and all required implementation actions are taken appropriately and in a timely fashion
  • Providing QA representation on External Manufacturing Boards and for projects (transfers, launches, due-diligence, other)
  • Monitoring and promoting positive Third-Party and Supplier Relationships, facilitating open and forthright communication, cooperation, and rapid issue resolution
  • Assessing the resource needs and identifying resources and planning to ensure Quality auditing of External Suppliers is carried out, confirming the schedule is adhered to, and follow-up actions are completed
  • Assessing and ensuring External Supplier readiness for HA inspections (PAI, directed, other)
  • Representing Quality liaison with customers where Polpharma Biologics Group provides CDMO services – coordinating and facilitating interactions with the respective Site Quality SMEs at Polpharma Biologics

If you have

  • Master’s or doctoral degree in a relevant field (pharmacy, biotechnology, biochemistry, chemistry)
  • 10 or more years of experience in the pharmaceutical industry, with direct experience with Pharmaceutical/Biopharmaceutical/API products
  • Experience in QA Operations, production, QC and/or other relevant operational areas, but must include minimum 5 years in QA, and 3 years of management and/or project management experience
  • Thorough knowledge of cGMP requirements
  • Strong understanding of regulatory requirements for commercial pharmaceutical and biological products
  • Proven track record with FDA, EMEA, and others
  • Strong understanding of risk assessment and risk management fundamentals/tools
  • Technical understanding of manufacturing/testing processes
  • Strong organizational and project management skills to be able to lead cross-functional teams
  • Strong leadership, influencing and communication skills
  • Ability to work and adapt to the company and local culture in a transformational complex environment
  • Can-do attitude and willingness to transform organization with strong focus on people
  • English - full professional proficiency, speaking or willingness to learn Polish is an advantage

We offer

  • Company car
  • Private healthcare
  • Cutting-edge technology equipment
  • Attractive salary
  • International work environment
  • Relocation package
  • And much more…
Join our Team!

Why you should work with us