Head of Technical Research and Development Quality
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 position you will lead the site Quality Assurance organization for Technical Research and Development. You will be tasked with establishing and maintaining the quality systems in the department and ensuring all the relevant GxP operations conducted comply with current regulation, legal and regulatory requirements as well as Polpharma Biologics internal regulations.

Your responsibilities

  • Establishing a phase appropriate Quality System for Technical R&D in Duchnice in close alignment with the Polpharma Biologics Group Quality Unit
  • Maintaining and continuously improving this Quality System to the growing scope of the department
  • Providing phase appropriate Quality Oversight for TR&D projects (process and analytical), with review and approval of studies protocols and reports
  • Providing technical quality input on all TR&D relevant matters, and assign relevant resources to support TRD& project initiatives
  • Coordinating consistency checks execution across TR&D for regulatory relevant source documents
  • Overseeing equipment and software qualification and validation, ensuring that Data Integrity requirements are reflected in systems and processes
  • Overseeing Quality systems management in the TR&D department, including management of activities such as quality events, change controls, documentation management systems and archiving, supplier management, training, and self-inspections
  • Coordinating preparation, support and follow-up for audits & inspections (authorities, partners, customers)

If you have

  • 5 years or more of Biologics Drug Substance manufacturing or QC testing for clinical or commercial supply
  • 2-3 years of Quality Assurance experience, preferably
  • 3 years of Technical Development experience (process or analytical)
  • University degree in such fields as: chemistry, biotechnology, molecular biology, biochemistry, pharmacy, medicine or related
  • Strong analytical knowledge (physicochemical and biochemistry), good upstream and downstream processing knowledge
  • Strong technical writing skills (familiarity with study/validation report writing, CMC documentation content, technical assessments
  • Very good knowledge of issues related to cGMP and quality system approach, ability to define phase requirements for TR&D
  • Good organizational skills
  • Teamwork and problem resolving skills, ability to risk based decisions and driving execution

We offer

  • Private healthcare;
  • Life insurance;
  • Private pension plan;
  • Relocation package;
  • and more…
Join our Team!

Why you should work with us