Quality Manager: Data Integrity

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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

This position provides Quality & Compliance oversight and management of the assigned Quality System elements for Polpharma Biologics.

The Quality Manager will provide Data Integrity compliance support and leadership to all facilities of Polpharma Biologics in the investigation, resolution and documentation of individual quality/compliance challenges and industry best practice.

This position will also be responsible for leading Data Integrity activities and monitoring of quality issues within the sites to assure reliability and compliance readiness and to identify events or trends that require investigation and improvement.

This position will be located in Gdansk, Poland and may require up to 10% domestic and/or international travel.

Position reports to: Group Head of Compliance.

Your responsibilities

  • Together with Group Head of Compliance, development of strategic direction and approach for Data Integrity (incl. Level 1 Plan)
  • Development of a detailed tactical plan for Data Integrity implementation (incl. Level 2 Plan)
  • Defining and rollout of the Data Integrity SOP and supporting tools e.g. risk-based assessments
  • Identifying and document systems and workflows that are impacted by data integrity requirements
  • Leading multi-disciplinary teams in the remediation of data integrity gaps and managing the ongoing status/progress reporting
  • Collaborating, mentoring, and training of other team members in all departments to ensure Data Integrity is understood and embedded within the organisation
  • Assisting in the timely investigation and resolution of data integrity issues, and the definition of support and maintenance procedures and approaches
  • Developing a solution toolbox that will be used to provide typical solutions
  • Having frequent interaction with Polpharma Biologics Management across the business and Sites
  • Understanding both technical and procedural requirements of data integrity
  • Performing data integrity gap assessments for paper-based and computerized systems processes in production, IT, and quality control
  • Proposing solutions, organizing resources for remediation of systems’ gaps
  • Writing and revising system administration & operational SOPs for data integrity requirements
  • Maintaining Data Integrity compliant with the Polpharma Biologics Quality System and with applicable international regulations

If you have

  • University degree (Biology or Biotech preferably)
  • Minimum 5 years of experience in commercial manufacturing, regulated environment
  • Minimum 3 years of managing QMS elements, preferably data integrity, computerized systems in a regulated environment
  • 3+ years people and project leadership experience
  • Extensive knowledge of cGMP's with specific knowledge of Data Integrity and industry best practices e.g. GAMP
  • Excellent communication skills (verbal and written), leadership, influencing & negotiating, and collaboration skills in a fast pace project environment are essential  
  • Fluent English
  • Experience with data and computer technologies incl. databases, either integrated or standalone, in a SQA or validation capacity in a QC/Production/IT environment preferred
  • Proven track record of influencing management, resolving complex compliance issues, and delivering on business results is preferred
  • Strong decision making and analytical skills, and the ability to manage multiple projects at the same time

We offer

  • Private healthcare;
  • Life insurance;
  • Pension plan above national standards;
  • Relocation package;
  • Additional free day;
  • and more…
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Why you should work with us