Site Data Integrity Lead
Duchnice
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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!
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.
Poznaj
Rezon Bio
Dołącz do zespołu ponad 1300 specjalistów produkujących zaawansowane leki biologiczne, które poprawiają jakość życia pacjentów na całym świecie.
Bazując na doświadczeniu Polpharma Biologics, Rezon Bio działa jako partner CDMO (Contract Development and Manufacturing Organization).
Dzięki nowoczesnym centrom biotechnologicznym w Gdańsku i Warszawie-Duchnicach oferujemy szeroki wachlarz możliwości karierowych w obszarach naukowych, technicznych i biznesowych.