Site Data Integrity Lead

Site Data Integrity Lead
Duchnice
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 Data Integrity strategy improvements and implementations. Cross-functional relationships building and ability to conjoin understanding of potential risks with skillful mitigation of such via effective regulation and procedures within GMP regulated environment will be crucial.

Your responsibilities
  • Manage and support the data integrity improvement strategy for the site and serve as point of contact for the site for the data integrity improvement strategy
  • Provide structure, guidance, alignment, and monitoring of Data Integrity improvement strategy across all functions
  • Perform risk assessments to determine high risk/priority equipment and audit trails and take appropriate action to bring into compliance
  • Assist in sourcing, assessing, and recommending instrumentation/equipment for purpose that mitigates identified risks
  • Establishes and Chairs the site Data Integrity Governance Team Meetings
  • Deliver compliant regulatory data integrity strategy and processes
  • Develop and implement site specific Data Integrity improvement plan including all relevant analytical laboratories and manufacturing operations on the site
  • Build partnerships with key site functions (e.g., Production, Technical, Planning, Engineering and Quality) to ensure alignment with data integrity requirements based on regulatory standards
  • Support the business in process development, benefits management, planning, and change management with regard to Data Integrity
  • Ensure that strategies and programs are well defined such that they can successfully deliver the required outcomes, with understood and managed risks, deliverables, benefits, costs, resources and quality
  • Provide subject matter expertise to regulatory inspections and interact with auditors as necessary
  • Creates/updates procedures as necessary to ensure operations awareness and importance of regulatory requirements and expectations
  • Routinely evaluates regulatory inspection documents and updates site procedures accordingly
  • Keeps the governance team aware of industry trends all within the scope of Data Integrity
  • Trains and motivates staff of all levels on the Data Integrity fundamentals
  • Provides time delivery of KPIs for Data Integrity
  • Escalate critical incidents according to the escalation process
If you have
  • Master Degree in the field of Science
  • 3+ years experience as a Data Integrity Lead in a pharmaceutical or other highly regulated GMP manufacturing environment
  • Experience performing risk assessments to determine high risk/priority equipment and audit trails and taking appropriate action to bring into compliance
  • Project management skills
  • Experience interfacing cross functionally with operational and senior level management within the organization
  • Technical expertise in Quality Assurance, Validation, Equipment and/or Laboratory Automation
  • Strong analytical skills to identify business requirements and to provide solutions to complex issues
  • Experience in most or all of the systems lifecycle (i.e., strategy, prioritization, design, development, implementation and operations) stages
  • Possesses strong leadership qualities and ability to motivate teams of highly skilled and trained individuals
  • Experience in effective interaction (both verbal and written) with all levels of the organization
  • Good written and verbal skills, fluent English.
Join our Team!
Why you should work with us
Contact us
career@polpharmabiologics.com

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