Data Integrity Lead
Warszawa

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 be responsible for leading Data Integrity Programs and Strategy at the Company level, Expert on DI regarding implementation of processes, procedures and practices to assure alignment with regulatory expectations for data integrity. This position will also be responsible for leading Data Integrity activities at sites, and monitoring of quality issues within the sites to assure reliability and health of the Quality System elements, identify events or trends that require investigations and improvement.

Your responsibilities

  • Together with Group Head of Compliance, develop strategic direction and approach for Data Integrity. Develop a detailed tactical plan for Data Integrity implementation;
  • Ensure continues fostering of Data Integrity awareness and culture at all levels of the company;
  • Define and rollout the Data Integrity SOPs and supporting tools. Establish and maintain effective procedure for handling of DI related incidents;
  • Develop governance and establish cross-functional DI community. Lead and work cross-functionally to understand, prioritize and mitigate DI risks. Lead the remediation of data integrity gaps and manage the ongoing status/progress reporting;
  • Proactively contribute in a hands-on fashion to the timely investigation and resolution of DI problems;
  • Support investigations, reviews and audits related to DI;
  • Performs data integrity gap assessments for paper-based and computerized systems processes in production, IT and quality control;
  • Support regulatory inspections and responses to observations, including preparatory activities for upcoming inspections, related to DI;
  • Collaborate, mentor with and train other team members in all departments to ensure Data Integrity is understood and embedded within the organisation.

If you have

  • A bachelor’s degree and a minimum of 5 years of experience in commercial manufacturing, regulated environment is required, preferred in Biologics or Biotech;
  • Minimum 10 years of pharmaceutical industry experience, with 5 years of Quality Assurance in a cGMP manufacturing environment, FDA regulated. At least 3 years of management and or project management experience;
  • Experience as a SME and/or host during FDA inspection is required;
  • Extensive knowledge of cGMP's is required with specific knowledge of Data Integrity and industry best practice e.g. GAMP. Solid knowledge of 21CFR-Part-11 and CSV;
  • 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;
  • A proven track record of influencing management, resolving complex compliance issues, and delivering on business results is preferred;
  • Excellent communication (verbal and written), leadership, influencing & negotiating, and collaboration skills in a fast-paced project environment are essential;
  • Strong decision making and analytical skills and the ability to manage multiple projects at the same time is required;
  • Ability to network and communicate with various functions and strong business acumen.
  • Ability to domestic travel, this position will be located in Warsaw and will require mostly travel to Gdansk and Warsaw sites.

We offer

  • Private healthcare;
  • Life insurance;
  • Pension plan above national standards;
  • Relocation package;
  • Additional free day;
  • and more…
Join our Team!

Why you should work with us

Contact us
[email protected]