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!
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 KPI's 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.