Head of Validation
Gdańsk

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

The Head of Validation is responsible for developing, implementing and managing the site validation strategies to meet cGMP and quality requirements on time and on budget to ensure that all equipment and systems are compliant with Regulatory Authorities’ expectations and related SOPs.

The role will supervise all validation activities required for an operational monoclonal antibody API commercial production facility with additional expansion to medicinal product manufacture. The role will be responsible for recruiting/managing a team of validation personnel both permanent and contract staff.

Your responsibilities

  • Review and approval of Validation Site Masterplan(s)
  • Mapping and planning QA validation activities and assessing the resources and timelines that are needed to complete activities
  • Leading Quality Assurance of Qualification and Validation of Facilities, Equipment, Utilities, Computerized Systems and Process/Cleaning validation activities
  • Review and Approval of validation protocols and reports, as required
  • Performing and approving Risk and/or Impact assessments with respect to validation and qualification activities
  • Review and QA Approval of Quality event records related to validation and qualification activities such as Deviation, CAPA, Change Controls etc.
  • Generation, review and approval of Quality Management System SOPs related to Validation, as required
  • Maintaining a high level of compliance focus in meeting Health Authority requirements and expectations (GIF, FDA etc.)
  • Validation strategy approach, decision making and regulatory expectation of decisions
  • Conducting risk-based evaluations, justifications and adequately reviewing and sponsoring the generation of QA systems derived documentation
  • Successful planning, execution and delivery of validation projects and associated documentation packages via engagement with business units (e.g. IT, Automation, Engineering, Quality Control), contractors and vendors
  • Collaborative work with engineering, validation and qualification teams to ensure selected vendors and service providers providing GxP validation related activities and services are suitably qualified in accordance with supplier/service provider qualification process
  • Recruitment, mentoring and managing a team of QA validation personnel
  • Develop, management and maintaining key internal and external stakeholder relationships

If you have

  • University degree in a science/engineering field (biotechnology, biology, pharmacy, chemistry or equivalent)
  • At least 5 years' experience in validation and qualification ideally within the biotechnology or pharmaceutical industry
  • 10+ years of experience in the pharmaceutical industry
  • Good EU GMP, US CFR and other pharmaceutical and biotechnological regulation knowledge
  • Experience in EMA and FDA regulated production facilities
  • Experience with Health Authority (GIF or FDA PAI)
  • Extensive knowledge on methods and approaches used in qualification of clean room systems, production equipment, computerized systems, process and cleaning validation processes
  • Experience with relevant international standards e.g. GAMP 5, ISO 10644, PDA
  • Experience in technology transfer is considered an advantage
  • Previous experience of FDA PAI is considered an advantage
  • Very good English is essential, speaking Polish is an advantage

We offer

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

Why you should work with us